To: Navanethem Pillay: An exceptionally important report from IRAN
On Wednesday, January 1, 2014 2:24 AM, bagher mohammadpour <bmp1337@yahoo.com> wrote Masih Ali-nejad <Masih.author@gmail.com>;:
On Friday, January 8, 2010 5:35 PM, bagher mohammadpour <bmp1337@yahoo.com> wrote:
Dear Sir,
You can send use the below e-mail ID:
Registry@ohchr.org
Best regards.
bagher
mohammadpour
<bmp1337@yahoo.co To
m> InfoDesk@ohchr.org
cc
19/12/2009 11:08
Subject
email address of High Commissioner
Dear Madam/Sir
I am an Iranian pharmacist. I intend to send an email for the High
Commissioner for Human Rights, miss "Navanethem Pillay".
could you please send me her email?
This is a vital and critical request!!!
I am looking forward to hearing from you SOON.
faithfully yours
b mohammadpour
You can send use the below e-mail ID:
Registry@ohchr.org
Best regards.
bagher
mohammadpour
<bmp1337@yahoo.co To
m> InfoDesk@ohchr.org
cc
19/12/2009 11:08
Subject
email address of High Commissioner
Dear Madam/Sir
I am an Iranian pharmacist. I intend to send an email for the High
Commissioner for Human Rights, miss "Navanethem Pillay".
could you please send me her email?
This is a vital and critical request!!!
I am looking forward to hearing from you SOON.
faithfully yours
b mohammadpour
Right Honorable Navanethem Pillay
UN High Commissioner for Human Rights
Dear Navanethem Pillay my story is too long to be described in few lines. Here I describe the main points in few words and leave the rest to two writings. To be more precise and clear I number the points.
1-I am a 51 Iranian pharmacist with about twenty years of experience in the "pharmaceutical industries" if IRAN. Three years ago I left Iran for finding a solution or a way to divulge 'a national crisis' internationally.
2-According to too many official documents from the "Ministry of Health" and many "manufacturers" nearly all the most basic scientific and technical and legal principles "are violated" by both sides in the production of medicines in IRAN.
3-The "crisis" is so wide and dangerous that it could be called "A National Disaster" and the most serious and intentional "Violation of Human Rights" in the world.
4-In the following writings I have provided enough evidences and details on the issue. I tried a lot to do something in Iran in favor of "the people" but as you know, and it is more evident these days than anytime in the past, all my measures were unsuccessful for known reasons. The government is ready to put all of a country and it's inhabitants into danger in favour of his "Legitimacy and Power and Existence".
5-In Paris I tried a lot but unfortunately no one paid any attention to the danger all the Iranians are subjected to. I could provide you a lot communications which have received no positive reply yet. It seems "Human Rights" is only a "political mean" in the hands of politics and politicians!!!
6-Even "official bodies" of USA and GB did not dare send me their professional and legal assessments on this issue and some even did not reply my communications at all. But the Pfizer (http://www.nytimes.com/2009/09/03/business/03health.html) case put the final proof on the truth of my assessment and understanding of the problem. I am sure that no one on the earth is able to deny the extreme importance and danger of the situation on the public health!
7 -The only way in which I will be "able and safe" to divulge this crisis internationally is being granted an "asylum visa" by a non-European country like Canada, USA, Australia or New Zealand because it is a long time that Europe has lost its "safety" for Iranian activists. And this is possible only under the support of you.
Right Honourable Navanethem Pillay, Pfizer case is the final proof of the "absolute importance" of the crisis in the pharmaceutical industries if Iran. On the other side few days ago I read an old peace of news about Miss Malalai Joya (http://en.wikipedia.org/wiki/Malalai_Joya) who received a lot of " Awards and honors" for a "90-second historical speech" and became the most famous figure in Afghanistan and an international Hero. In her Nano-speech she said nothing no one did not know about Afghanistan and secondly no one benefited from in the world including Afghanistan. There are a lot of absolutely STRANGE and somehow crazy reactions to her and her Nano-speech (above address).
A Persian poet says:
"I am a dumb dreamer and the world are deaf;
Neither I can talk to them nor they could hear me."
This poem is the most exact and the best expression of my social and professional life and I found the West as closed to me as Iran.
Right Honourable Navanethem Pillay, I am in urgent need of your to divulge that crisis which has continued during the life of IRI. Please, please, please help me and save the rest of my life to be spend in that absolute Hell.
I am eagerly looking forward to hearing from you soon; I and whole of a nation are in urgent need of you.
Respectfully yours
B Momammadpour
Paris/ France.
Attachments:
(I did not edit or shorten the first two letters to show the theoretical background of the crisis and my critical approach.)
1-The letter originally prepared for some politicians.
2- My CV which contains some special and additional aspect of the crisis.
3&4-The replies of FDA and to my letter in it asked them to send me their comments and the assessment of the problem.
1-THE FIRST LETTER
A person may cause evil to others
not only by his actions
but by his INACTION,
and in either case he is justly
accountable to them for INJURY.
(page 70)
Very few facts
are able to tell their story
without comments
to bring out their meaning.
(page 80)
John Stuart Mill, On Liberty,
1058, Penguin Classics 1985
When the foundations are being destroyed,
what can the righteous do?
(Psalm 11:3
IN IRAN
the struggle between
Liberty and Authority
has never been so harsh and bloody
during the last century.
The government uses all his power
against his subjects
no less than against external enemies.
Mill says
“But in political and philosophical theories
success disclose defaults and infirmities
which failure might have concealed from observation.”
So the severity of this struggle
puts a further proof on
the Tyrannical nature of ideological and theological
(as happened in Europe) regimes.
B. Mohammad pour,
Paris, France.bmp1337@yahoo.com
--------------------------------------------------------------------
The Right Honorable Stephen Harper
The prime minister of Canada
In reply to my previous letter on a national disaster in the pharmaceuticals industries of Iran, you advised me to present my documents to the Canadian embassy in Paris, but unfortunately they neither took your letter nor my documents and claims serious and simply solved the problem by saying their mere mission is on the relations between Ottawa and Paris. They disregarded that special and urgent cases need deeds and reactions of the same kind. Once again in Vienna I contact your Embassy but they did what I had experienced in Paris: it seemed to me finding a simple legal basis to justify their inaction and having something LEGAL to put in hands of people is their ultimate ability and seems a remarkable achievement to them. Today it is an received opinion and belief, both nationally and internationally, that: Any commitment to Human Rights in Iran must be asserted by deeds, for words, on this subject, it is a long time, have nearly exhausted their POWER.
What I am writing you about is an absolutely incredible and disastrous case of nationwide HRs violation in the history of the Islamic Government and the worst of them. If only critics and social activists and political and journalists figures are subject to political and judicial persecution and torture, this crisis affects all innocent members of a whole nation and no one could escape from its dangers. The simplest cases of those mistakes deserve up to few million dollars of fine and about ten years jail in the North America and something like this in Europe. If violation on human rights in Iran, like in all other countries is measured according to the current international and accepted understanding of the subject, I assure you what I try to divulge is the worst case in the world of a deliberate and nationwide violation has ever been committed by any government against its people. My claims are totally based on too many official documents from many
manufacturers and the ministry of health and they prove that this problem is a STRUCTURAL defect and has no simple and easy solution; no expert could believe what is going on in Iran in this field.
I and my people are in Urgent need of a minute part of international humanitarian aids of your country as a serious critics of the Islamic Government for his tyrannical and inhumane deeds and behavior. I presented the enclosed letter to the Canadian embassy in Vienna but unfortunately they did what I had experienced in Paris. Till now European countries have rejected my request for help in favor of my nation four times and proved their commitments on support and advancement of human rights, especially in Iran: they proved they love law too much more than justice (like the ruler of Lillipot in Gulliver story). Spending more than thirty months in Europe has depleted all my financial supports. My long experience in pharmaceutical industries and abilities in English language (more information in the enclosed letter) make my settlement an easy and successful task and here I promise to pay back the cost of my reaching there.
I hope your humane interests and commitment of your country to advancement of HRs help me urgently to bring this lifelong struggle on which I scarified all my life and legitimate social interests to its victorious end in favor of a big nation who are spending the absolute darkest period of their social life during the last century.
This section be corrected according to the reply/not reply of pharm asso of Canada
Few days ago and through an eamil I asked FDA, absolutely the best and biggest organization of the world on the subject, to send me their opinion and judgment on the nature and consequences of this crisis; you find their reply and my letter at the of this letter. But because of those reasons that you know them better than me, they rejected to state their opinion, but they would Tell You all the story and Only They could tell you the truth about the dimensions of this crisis. Normally organizations like FDA are the best international sources for this kind of counseling and always welcome it but silence of FDA does not deter experts from hearing the truth. Unfortunately many rejected my documents and claims been evaluated by official professionals and FDA’s will be its first ,and I believe they will confirm my opinions and claims on the vital importance and threatening nature of the crisis in pharmaceutical industries of Iran. Without their assessment
and evaluation all the truth will miss because according to J. S. Mill:
Since many year ago Europe has lost its safety and security and nearly all active oppositions have moved to the USA and Canada. So my request for support and being in your country is not a kind of ordinary immigration requests which are normally subject of a long and time-consuming procedure; it is somehow a political and national request that requires your special favor and supports. I hope receive your supports very soon till all the Iranians benefit from the righteous commitment of your country to their well-being.
Respectfully yours
B Mohammad pour
----------------------------------------------------------------------
1-FROM Tabriz university in Iran I received my Pharm. D. degree at the beginning of 1985. I have spent all my professional life in service of the pharmaceutical industries of Iran. From the very first weeks I faced a lot of huge scientific and practical mistakes in all aspect of production of medicinals. Unfortunately leaving a company and joining another only changed my mistrust in inadequacy of theoretical and practical arrangements into an absolute faith in existence of a nationwide disaster in these industries.
My DISASTEROUS and incredible findings in every company put them in danger of a devastating earthquake with unpredictable consequences not only for themselves but for MoH who carried all and also the final responsibility of everything industries did & DO. So I always forced to move (actually I was dismissed) to another company and repeating the same story.
2-ABOUT fifteen years ago I wrote a long and critical article on this subject but no one dared to publish it for having serious consequences on Government’s legitimacy and would put both the publisher and writer in danger of harsh reactions of the regime.
3-THE followings are only a short list of those serious mistakes:
§- Usage delicate and unstable materials like vitamins five to seven years after the end of their Expiration Dates.
§- Huge mistakes in laboratory control methods of Raw Materials and finished products so that mistakes up to fifty percent, and usually more, could not be detected or could be introduced.
§- Mixing of raw well water with syrups for too many years because of a design defect in the filling machine.
§- correction of a totally wrong manufacturing procedure reduced the manufacturing time from ten hours in tow days to three hours in one day. A further correction of its formulation reduced its excipients about 1300 kg per 3000 l: this means their ignorance put the metabolic system of children under a severe pressure for absolutely no benefit or necessity. Its bitter taste and disgusting smell vanished for ever.
§- Defect in installation of a washing machine led to remaining about two milliliters of an extremely concentrated Chlorine water, one of the most dangerous Oxidizing agents, in the washed bottles used for bottling the above mentioned pediatric antibiotic suspension.
§- Usage an totally Inactive microbial preservative in an antacid suspension for too many years for the complete ignorance of the most basic principles of chemistry and biology.
§- For a while a company introduced a preparation without any Active component (drug molecules) into market for Economical reasons.
§- Active ingredient of an antacid suspension and tablets were respectively 25% and 16% less than the label amounts in at least two company.
§- In a comprehensive report, in more than one hundred pages, I proved that nearly what I knew till then in that company were wrong to the strongest and widest meaning of the word of wrong.
§- And there are too many other cases which I could not mention them for ,at least, the matter of space.
§- correction of filtering technique of a sugar syrup prevented the entrance of considerable amount of any kinds of particles into a pediatric antibiotic suspension.
§- Some people died in a hospital in Tehran under the usage of an imported general anesthetic for the wrong quality control process in the Central QC Laboratory of MoH.
§- Some imported blood preparations by a governmental department infected too many by HIV because of the poor QC methods employed by MoH.
§- A manufacturer sent seven files to MoH to gain production licenses. My comprehensive analysis proved that they were ABSOLUTLY, in the strongest meaning of the word, wrong and no one can find even a scientific or literal sentences in ALL of them. Many correspondences from MoH proved and yet proves that none of those huge and disastrous mistakes were detected by MoH officials or many pharmacist employees oh that company. Some of those drugs were Cardiac and anti-Asthmatic.
§- All bottles of a Pediatric dried suspension of Doxycycline released to market in spite of being degradated because of the high humidity of filling department.
§- Contaminated injectables (Oxytertracycline) with DUST of Carbon during the sealing step, released to market by the previous case company.
§- A hyperosmotic local anesthetic which was prepared by a governmental agent paralyzed some, especially from both legs following its injection into the spinal cord.
§- Washings and rain water entered the main water reservoir of a company for an unknown period of time in spite of repeated inspections of MoH agents and too many pseudo-pharmacist employees during in all those long years.
§- GMP is an antiproductive concept, for its exercising would stop everything. Instead manufacturers strictly obey BMP(Bad Manufacturing Process). Violation of any GMP rules, according to current regulations would lead a preparation to be recognized as rejected and in the light of this principles we are only able to produce rejected preparations.
4- On 29,09,2006 I entered Paris for an international exhibition on pharmaceutical materials. In hope of finding a solution for that crisis I stayed there but failed to gain any support to divulge this absolute case of Human Rights violation. In France I received tow negatives and after about twenty seven months decided to go back to Iran. In Vienna airport and after a short stopI experienced an intolerable anxiety and stress and lost my flight. In hope of finding a solution I applied in Austria but as in France I received tow negatives. By the rule of “No one can believe what he does not understand”, I asked in both countries my claims and documents be evaluated by experts but they disregarded this legal request.
5-During all of my professional life, somehow I was the best between my colleagues. All information and documents by help of them I discovered all those huge mistakes were also available to them but no one detected and noticed any mistakes. Successful and important improvements in nearly all aspect of pharmaceutical industry also include in my professional background. Opportunities for exercising habit of critical thinking and the exceptional capacity in application of creativity tied me strongly to my job in spite of depriving from all legitimate economical and social benefits. My collection of scientific books is more than three thousand volumes in different subjects including natural and human sciences. My studies in many aspect of English language are noticeable and are based on more than two hundred books on subjects like usual textbooks to linguistics and psychology of learning and teaching foreign languages. About sixty monolingual dictionaries in
different types and size and more than fifteen volumes on grammar at different levels are some subsets of my personal library. In Paris I studied three books on grammar two times and in more then three thousand pages. This language background and long and active experience in pharmaceutical industries make settlement a simple and short task at both social and professional levels. Considerable studies in Management, Organization, Organizational behavior, Ergonomy, Sociology, Social psychology, Psychology, Cognitive psychology, Educational and learning psychology, Philosophy and Philosophy of education provided me a nearly reliable mental awareness and critical mind.
My DISASTEROUS and incredible findings in every company put them in danger of a devastating earthquake with unpredictable consequences not only for themselves but for MoH who carried all and also the final responsibility of everything industries did & DO. So I always forced to move (actually I was dismissed) to another company and repeating the same story.
2-ABOUT fifteen years ago I wrote a long and critical article on this subject but no one dared to publish it for having serious consequences on Government’s legitimacy and would put both the publisher and writer in danger of harsh reactions of the regime.
3-THE followings are only a short list of those serious mistakes:
§- Usage delicate and unstable materials like vitamins five to seven years after the end of their Expiration Dates.
§- Huge mistakes in laboratory control methods of Raw Materials and finished products so that mistakes up to fifty percent, and usually more, could not be detected or could be introduced.
§- Mixing of raw well water with syrups for too many years because of a design defect in the filling machine.
§- correction of a totally wrong manufacturing procedure reduced the manufacturing time from ten hours in tow days to three hours in one day. A further correction of its formulation reduced its excipients about 1300 kg per 3000 l: this means their ignorance put the metabolic system of children under a severe pressure for absolutely no benefit or necessity. Its bitter taste and disgusting smell vanished for ever.
§- Defect in installation of a washing machine led to remaining about two milliliters of an extremely concentrated Chlorine water, one of the most dangerous Oxidizing agents, in the washed bottles used for bottling the above mentioned pediatric antibiotic suspension.
§- Usage an totally Inactive microbial preservative in an antacid suspension for too many years for the complete ignorance of the most basic principles of chemistry and biology.
§- For a while a company introduced a preparation without any Active component (drug molecules) into market for Economical reasons.
§- Active ingredient of an antacid suspension and tablets were respectively 25% and 16% less than the label amounts in at least two company.
§- In a comprehensive report, in more than one hundred pages, I proved that nearly what I knew till then in that company were wrong to the strongest and widest meaning of the word of wrong.
§- And there are too many other cases which I could not mention them for ,at least, the matter of space.
§- correction of filtering technique of a sugar syrup prevented the entrance of considerable amount of any kinds of particles into a pediatric antibiotic suspension.
§- Some people died in a hospital in Tehran under the usage of an imported general anesthetic for the wrong quality control process in the Central QC Laboratory of MoH.
§- Some imported blood preparations by a governmental department infected too many by HIV because of the poor QC methods employed by MoH.
§- A manufacturer sent seven files to MoH to gain production licenses. My comprehensive analysis proved that they were ABSOLUTLY, in the strongest meaning of the word, wrong and no one can find even a scientific or literal sentences in ALL of them. Many correspondences from MoH proved and yet proves that none of those huge and disastrous mistakes were detected by MoH officials or many pharmacist employees oh that company. Some of those drugs were Cardiac and anti-Asthmatic.
§- All bottles of a Pediatric dried suspension of Doxycycline released to market in spite of being degradated because of the high humidity of filling department.
§- Contaminated injectables (Oxytertracycline) with DUST of Carbon during the sealing step, released to market by the previous case company.
§- A hyperosmotic local anesthetic which was prepared by a governmental agent paralyzed some, especially from both legs following its injection into the spinal cord.
§- Washings and rain water entered the main water reservoir of a company for an unknown period of time in spite of repeated inspections of MoH agents and too many pseudo-pharmacist employees during in all those long years.
§- GMP is an antiproductive concept, for its exercising would stop everything. Instead manufacturers strictly obey BMP(Bad Manufacturing Process). Violation of any GMP rules, according to current regulations would lead a preparation to be recognized as rejected and in the light of this principles we are only able to produce rejected preparations.
4- On 29,09,2006 I entered Paris for an international exhibition on pharmaceutical materials. In hope of finding a solution for that crisis I stayed there but failed to gain any support to divulge this absolute case of Human Rights violation. In France I received tow negatives and after about twenty seven months decided to go back to Iran. In Vienna airport and after a short stopI experienced an intolerable anxiety and stress and lost my flight. In hope of finding a solution I applied in Austria but as in France I received tow negatives. By the rule of “No one can believe what he does not understand”, I asked in both countries my claims and documents be evaluated by experts but they disregarded this legal request.
5-During all of my professional life, somehow I was the best between my colleagues. All information and documents by help of them I discovered all those huge mistakes were also available to them but no one detected and noticed any mistakes. Successful and important improvements in nearly all aspect of pharmaceutical industry also include in my professional background. Opportunities for exercising habit of critical thinking and the exceptional capacity in application of creativity tied me strongly to my job in spite of depriving from all legitimate economical and social benefits. My collection of scientific books is more than three thousand volumes in different subjects including natural and human sciences. My studies in many aspect of English language are noticeable and are based on more than two hundred books on subjects like usual textbooks to linguistics and psychology of learning and teaching foreign languages. About sixty monolingual dictionaries in
different types and size and more than fifteen volumes on grammar at different levels are some subsets of my personal library. In Paris I studied three books on grammar two times and in more then three thousand pages. This language background and long and active experience in pharmaceutical industries make settlement a simple and short task at both social and professional levels. Considerable studies in Management, Organization, Organizational behavior, Ergonomy, Sociology, Social psychology, Psychology, Cognitive psychology, Educational and learning psychology, Philosophy and Philosophy of education provided me a nearly reliable mental awareness and critical mind.
--------------------------------------------------------------------------------------
I like to bring this letter to its end by some quotations from Mill whose wisdom and humanity glazes eyes of the wise and no one ignores him without a great loss of knowledge and discoveries on nature of Human and Power as a necessary and unavoidable Evil of his life in societies.
Usually there are persons
who form an exception
to the apparent unanimity of the world on any subject… and truth would lose something
by their silence
(page111, On Liberty).
The mere refusal to bend the knee
to the customs and power
is itself a service
(page 130, On Liberty).
Usually there are persons
who form an exception
to the apparent unanimity of the world on any subject… and truth would lose something
by their silence
(page111, On Liberty).
The mere refusal to bend the knee
to the customs and power
is itself a service
(page 130, On Liberty).
Whatever precautions
might be taken against
the oppressive exercise of power
(page?, On Liberty)
----------------------------------------------------------------------
E P I L O G U E
Regarding current legal system and scientific status of pharmaceutical industries in the modern world, I strongly believe that divulging the crisis in the pharmaceutical industries of IRAN would discover a new and incredible dimension of dark and brutal nature of the Islamic government and would have its vital and devastating consequences in practical criticism of theological and ideological types of governments and, at the same time will be the biggest defense in favor of Iranians against the tyrannical application power of Islamic regime.
And at the personal level I hope your and your Country’s support provide me the opportunity of life in an Open, Democratic and Modern society after a long struggle with a wild Authority in the most hidden and darkest border of fight.
And at the personal level I hope your and your Country’s support provide me the opportunity of life in an Open, Democratic and Modern society after a long struggle with a wild Authority in the most hidden and darkest border of fight.
2-THE SECOND LETTER
"MY CV"
MOHAMMAD POUR, BAGHER (Male, PHARM. D.)NO 32, BARZEGARPOUR LANE,
HKOSH ST.,
MORTAZAVI CROSS,
TEHRAN 13547,
IRAN.bmp1337@yahoo.com
HKOSH ST.,
MORTAZAVI CROSS,
TEHRAN 13547,
IRAN.bmp1337@yahoo.com
(At the moment I am in Paris)
PERSONAL DETAILS:
FAMILY NAME: MOHAMMAD POUR
NAME: BAGHER
DOB: 30/04/1958
POB: TEHRAN/IRAN
NO OF ID CARD: 2047
FATHER: MOHAMMAD HOSSEIN
MARRAGE: DIVORCED
CHILDREN: MOHAMMAD; 20 YEARS OLD; TEHRAN/IRAN; UNIVERSITY STUDENT OF PHYSICS IN TEHRAN.
EDUCATION:
1-HIGHSCHOOL DIPLOMA: 1976, NATURAL SCIENCES
2-UNIVERSITY DIPLOMA: PHARM. D.; TABRIZ UNIVERSITY, TABRIZ, IRAN; 1976-1985 (INCLUDING REVOLUTION & CULTURAL REVOLUTION OFF-DAYS)
3-OTHERS: ISO 9000 SERIES, TWO COURSES: 1-STRUCTURE & DEVELOPMENT, 2-QUALITY MANAGEMENT AUDITOR.
PROFFESSIONAL BACKGROUND:
1-APR 1985-JUL 1986; RAZAK PHARMA CO, MANAGER OF PACKING DEPT.
2-JUL 1986-NOV 1988; EMERGENCY MILLITARY SERVICE.
3-MAR 1986-NOV 1990; MANDATORY SERVICE FOR MOH.
4-JAN 1991-AUG 1992; ALBORZ DAROU PHARM CO, MANAGER OF LIQUID DEPT.
5-JAN 1993-OCT 1994; PHARMA CHIMIE; R&D DEPT. MANAGER.
6-OCT 1994-SEP 1995; PYRAIEH COSMETIC & HYGIENIC CO; RESPONSIBLE PHARMACIST.
7-DEC 1995-JAN 1997; LOGHMAN PHARM CO; PRODUCTION MANAGER.
8-NOV 1997-VOV 1999; ALHAVI PHARM CO; PRO- DUCTION MANAGER.
9-JUN 2000-JUN 2001; TEHRAN DAROU PHARM CO;
RESPONSIBLE PHARMACIST.
10-SEP 2002-DEC 2006; SHAHRE DAROU PHARM CO;
LIQUID PRODUCTION MANAGER; the last position:
QC MANGAER for more than three years.
ACHIEVEMENTS:A NECESSARY INTRODUCTION: Because of my special interests in nearly all aspect of pharmaceutical production, always I was involved in many different kind of professional and scientific activities. At the same moment there were two others reason for the diversity of my interests and engagement in different aspect of pharmaceutical production. The first reason is that any kind of industrial production is an integrated chain and steps of different activities that form, or MUST form a logical sequence of tasks in each, the previous step object is the initial material for the next: thus the successful result or end of each step MUST be evaluated on, first, the quality of initial material (as defined above) and, second, the correctness of the next step activity AND its proper and successful exercise. So, under the light of the mentioned principle, I was always aware that detection of the nature of each single activity OR problem depends totally and absolutely
on our understanding of all the production procedure as a Single and Unified Activity, and secondly without having a clear mental map and theoretical understanding of what WE are doing, neither we could evaluate the correctness of each step achievement nor we would be able to Detect, Define, and solve our problems. This was the first reason of my notice to and interest in different fields of pharmaceutical production from QC of materials to Formulation and Process Design up to the definitions of quality parameters and the methods of their assessment.
And on the basis of my understanding and familiarity with the educational deficiencies in universities, and more importantly, the gross dependence and reliance of Pharmaceutical industry as a branch of Chemical Industry on Natural Sciences, I have tried to compensate what educational system was never able to provide, AND KNOWING THAT without a basic understanding of them nothing could be done without a gross inclusion of errors and fatal mistakes, I tried, as far as I could, to Absorb what I needed as an Industrial pharmacist, what usually none of my colleagues could provide me as a pharmacist and colleague. For example, my first official position as QC manager was in Shahre Darou but I was the main participant of QC lab in Alhavi or in Alborz Darou, and as the manager of Production my engagement in understanding all possible scientific or technical basis of our activity was clear, deep, and firm. This can be believed noticing the diversity of my
activities and corrections which spread from too early initial step of Water System up to designing and writing the most com-prehensive and practical and Scientific based Analytical Procedure FOR QC Laboratory and up to Stability and Organoleptic properties of medicinals. Two principles have always guided my professional life, from biology and manage- ment: Nature Does Nothing for Nothing (We need have reasons for our choices) & Always There Could Be a Better Way (We must keep our mind open to new ideas and to the future). Therefore all the below cases are the fruits of one or both of the above Principles.
Here I could not provide a complete list of my activities nor I could provide necessary convincing information on them. This list only mentions the core and heart of the problems without necessarily any notice to the company and some time out of historical order and under the force of limited time. (a late contemporary Iranian poet says: And suddenly/ Very soon/ It becomes late; Ghaisar-e Amin Pour.)
A SHORT LIST OF ACHIEVEMENTS
1)Correction of many mistakes in different laboratory control methods of Raw Materials and finished products in many companies; mistakes up to fifty percent, and usually more, could not be detected or could be introduced.
2)Mixing of raw well water with syrups after too many years prevented and it was because of a design defect in the filling machine.
3)Correction of a totally wrong manufacturing procedure reduced the manufacturing time of a pediatric liquid antibiotic from ten hours in tow days to three hours in one day and consequently production capacity of that production increased 600%. A further correction of its formulation reduced its excipients about 1300 kg per 3000 Liter (And scientific proof for the former procedure being mistake and justification of correctness of the new were totally based on the best texts of the time.) Its bitter taste and disgusting smell and taste and permanent default of undispessed agglomerates vanished for ever.
4)Defect in installation of a washing machine led to remaining about two milliliters of an extremely concentrated Chlorine water in the washed bottles used for bottling the above mentioned pediatric antibiotic suspension.
5)Usage an totally Inactive microbial preservative in an antacid suspension corrected after too many years and by the aid of the most basic principles of chemistry and biology an active one selected.
6)Active ingredients of an antacid suspension and tablets were respectively 25% and 16% less than the label amounts in at least two company and for an unknown time; I corrected them.
7)In a comprehensive report, in more than one hundred pages, I proved that nearly what I knew till then in that company were wrong to the strongest and widest meaning of the word of wrong and provided detailed comments on all of them in three field: Production, QC, and Management.
8)Correction of filtering technique of a sugar syrup prevented the entrance of a considerable amount of any kinds of particles into a pediatric antibiotic suspension.
9)My comprehensive analysis (in about two hundred pages), as the Responsible Pharmacist, of seven files on design, production, and QC procedures of six important medicines (some were life-saving) proved that they were ABSOLUTLY wrong in the strongest meaning of the word.
10)Correction of design of entrance of the main water reservoir of a company prevented entrance of washings and rain water in it and it continued for an unknown period of time
11)Correction of an administrative procedure reduced the usage of plastic spoons and aluminum caps up to 25%.
12) Correction of water purifying system where the saline water for regeneration of ion-exchanging resins was prepared in old and oxidized iron container and was dark-brown by plentifullnes of Ferric Oxide.
A SHORT LIST OF ACHIEVEMENTS
1)Correction of many mistakes in different laboratory control methods of Raw Materials and finished products in many companies; mistakes up to fifty percent, and usually more, could not be detected or could be introduced.
2)Mixing of raw well water with syrups after too many years prevented and it was because of a design defect in the filling machine.
3)Correction of a totally wrong manufacturing procedure reduced the manufacturing time of a pediatric liquid antibiotic from ten hours in tow days to three hours in one day and consequently production capacity of that production increased 600%. A further correction of its formulation reduced its excipients about 1300 kg per 3000 Liter (And scientific proof for the former procedure being mistake and justification of correctness of the new were totally based on the best texts of the time.) Its bitter taste and disgusting smell and taste and permanent default of undispessed agglomerates vanished for ever.
4)Defect in installation of a washing machine led to remaining about two milliliters of an extremely concentrated Chlorine water in the washed bottles used for bottling the above mentioned pediatric antibiotic suspension.
5)Usage an totally Inactive microbial preservative in an antacid suspension corrected after too many years and by the aid of the most basic principles of chemistry and biology an active one selected.
6)Active ingredients of an antacid suspension and tablets were respectively 25% and 16% less than the label amounts in at least two company and for an unknown time; I corrected them.
7)In a comprehensive report, in more than one hundred pages, I proved that nearly what I knew till then in that company were wrong to the strongest and widest meaning of the word of wrong and provided detailed comments on all of them in three field: Production, QC, and Management.
8)Correction of filtering technique of a sugar syrup prevented the entrance of a considerable amount of any kinds of particles into a pediatric antibiotic suspension.
9)My comprehensive analysis (in about two hundred pages), as the Responsible Pharmacist, of seven files on design, production, and QC procedures of six important medicines (some were life-saving) proved that they were ABSOLUTLY wrong in the strongest meaning of the word.
10)Correction of design of entrance of the main water reservoir of a company prevented entrance of washings and rain water in it and it continued for an unknown period of time
11)Correction of an administrative procedure reduced the usage of plastic spoons and aluminum caps up to 25%.
12) Correction of water purifying system where the saline water for regeneration of ion-exchanging resins was prepared in old and oxidized iron container and was dark-brown by plentifullnes of Ferric Oxide.
13)Granulating procedure of an antibiotic tablet was totally unjustified and wrong so dried granules were completely incompressible and pressing were divided into many small time-consuming and hard steps and finally lead to extremely fragile and rough surface tablets.
14)Application the simplest rules of Algebra and Arithmetic proved that nearly all QC calculations are wrong and interpretation of results were arbitrary and had no scientific basis or support in the eyes of International Authorities like FDA and...
15)As a responsible person in a hygienic company I did a vast investigation on formulation of Dishwashing Liquids and to a great extent discovered none knew the exact scientific basis of making a chemically (at least) justified product and usually the mixing order of components were wrong so unwanted chemical reaction between those that had not to bear it, lead to destruction of chemicals and a production of unknown components with unpredictable
activity and side effects. That article is available.
16)Correction of preparation method of a cellulosic gum increased its viscosity 300% and reduced its usage to one-third.
17)Investigation of spectroscopic method of analysis in USP proved that it was (and ‘is’ till today) incomplete and BP provided no method; even the USP method requires you the answer to be able to solve your problem!! I find a very simple and extremely useful formula to complete USP method and removed its logical controversy. Further examination of that formula showed that it can be used successfully in designing in-home methods of spec- troscopic measurements and make us able to do what we want by positive application of our limitations and possibilities. The reply of the Chief Editor of that part of USP was the strangest possible by a USP’s Editor:
We do not have time to study your formula and letter.
18)In reply to request of a General Manager I wrote a detailed report on nearly all aspect of the life of that organization. In that letter I proved scientific mistakes had invaded all era of Organizational Life and quality is Accidental and Unintentional. That letter contains about fifty comments on all aspects, directly or indirectly, quality both as an activity or a goal and, the importance of production as the heart of an industrial unit. In another activity I corrected the analytical methods of the following materials with the stated percentage of errors:
MgO, minus 40%; Fe Fum., plus 900%; assay test of a Decongestant in a syrup, minus 92.5 in one respect and plus 1250% in another; Ca(ion) in a capsule minus 100%. And too many others, for example wrong adjustment of a Colloid Mill lead to destruction of about 200,000 bottles of Chloramphenicol suspension.
19)Stabilization of an extremely unstable Ferrous solution in a new formulation and reducing its Coloring effect on teeth.
20)Designing and improving many technical forms of production, QC laboratory, and administrative department by: Application of similarity in similar forms; Canceling unrelated information and/or items; Inclusion of necessities; and Finally adaptation of their design and follow with the administrative procedures and require- ments of GMP, ISO, and Internal Design of organization. Importance of this principle has made it a feature and criteria of suitability of organizations by this formula:
Structure and efficiency of a well-designed organization,
And the competence of its creators ,
are defined in, and mirrored by its FORMS respectively.
(in other words: good FORMS are self-defining and the best guidance and MAP on your location in the organization.) Many forms by application of this principle were corrected.
21)Application of ‘USP Introduction’s recommendation, or what can be even interpreted as ORDER ,on the Necessity of Internalizing and Absorption of scientific basis of each test and monograph, proved that by simple translation of them into the mother-tongue of technicians and rewriting or typing them in a tidy format nearly Nothing of knowledge would be gained and no responsibility would be fulfilled, and brings not even a small portion of practical efficiency and expert: Any activity in the filed of application of Natural Sciences, in their most modern meaning of them, without bearing a Good and Deep understanding of their theoretical ground in mind, is Only and Only a ‘sleepwalking’ and sleepwalker fells and stops very soon by the first obstacle.
Some sample were done. All the above huge mistakes in analytical procedures and results were the fruits of ignorance to that order and its importance and were solved only ay its application. Those samples proved that in some cases the Supporting Information of an analysis could be up to ten times of its text and need a lot of references be used at the same time.
MORE POINTS ON PERSONAL INTERESTS:
1)My personal library has about three thousand volumes of books. They could be divided into two main category; first books on Human sciences and second those on Natural sciences. Some books in the former part have some applications on organizations and by this way find some links to environmental parameters of scientific
Of human society; for example principles of philosophy, psychology, sociology, management or even politics and some concepts of biology have strong applications in organizations and through this way could help in understanding of those specific problems which have been a constant part of human life in society and history.
2)My Natural Sciences books are on the subjects: Physics (as the king, head and spring of all other discipline in this field), Calculus, Linear Algebra, Geometry, Statistics, Pharmaceutical statistics, Statistical design, Thermodynamic, General chemistry, Organic chemistry, Inorganic chemistry, Medicinal chemistry, Pharmaceutical chemistry, Physical chemistry, Instrumental analytical chemistry, Unit operations in chemical engineering, Perry’s handbook of chemical engineering, Engineering and mechanical design, Industrial pharmacy(many), Pharmacology: Basic, Clinical, Molecular; Drug information, Internal medicine, Biopharmaceutics, Pharmacokinetics, Quality control, Statistical quality control, GMP regulations, and …
3)My Human sciences books on related fields to Organizations are on subjects: Sociology, Psychology, Social psychology, Management, Organizational Behavior,
Organization design, Ergonomy, Job design, ISO applications and …
4)My main interest is reading and reading and reading, and then Hiking, Photography, Handicraft, Persian Poem and Language and Vocabulary and Prose style; English language (more than two hundred books on different aspect of English language including about sixty volume monolingual English-English dictionaries of different kinds and size and publishers).
5)This letter is the example of my writing ability in English and, my speaking is nearly at the same level and I have no difficulty in reading, understanding and interpretation of scientific and pharmaceutical texts and references.
B Mohammad pour
Pharm. D.
May 2009
14)Application the simplest rules of Algebra and Arithmetic proved that nearly all QC calculations are wrong and interpretation of results were arbitrary and had no scientific basis or support in the eyes of International Authorities like FDA and...
15)As a responsible person in a hygienic company I did a vast investigation on formulation of Dishwashing Liquids and to a great extent discovered none knew the exact scientific basis of making a chemically (at least) justified product and usually the mixing order of components were wrong so unwanted chemical reaction between those that had not to bear it, lead to destruction of chemicals and a production of unknown components with unpredictable
activity and side effects. That article is available.
16)Correction of preparation method of a cellulosic gum increased its viscosity 300% and reduced its usage to one-third.
17)Investigation of spectroscopic method of analysis in USP proved that it was (and ‘is’ till today) incomplete and BP provided no method; even the USP method requires you the answer to be able to solve your problem!! I find a very simple and extremely useful formula to complete USP method and removed its logical controversy. Further examination of that formula showed that it can be used successfully in designing in-home methods of spec- troscopic measurements and make us able to do what we want by positive application of our limitations and possibilities. The reply of the Chief Editor of that part of USP was the strangest possible by a USP’s Editor:
We do not have time to study your formula and letter.
18)In reply to request of a General Manager I wrote a detailed report on nearly all aspect of the life of that organization. In that letter I proved scientific mistakes had invaded all era of Organizational Life and quality is Accidental and Unintentional. That letter contains about fifty comments on all aspects, directly or indirectly, quality both as an activity or a goal and, the importance of production as the heart of an industrial unit. In another activity I corrected the analytical methods of the following materials with the stated percentage of errors:
MgO, minus 40%; Fe Fum., plus 900%; assay test of a Decongestant in a syrup, minus 92.5 in one respect and plus 1250% in another; Ca(ion) in a capsule minus 100%. And too many others, for example wrong adjustment of a Colloid Mill lead to destruction of about 200,000 bottles of Chloramphenicol suspension.
19)Stabilization of an extremely unstable Ferrous solution in a new formulation and reducing its Coloring effect on teeth.
20)Designing and improving many technical forms of production, QC laboratory, and administrative department by: Application of similarity in similar forms; Canceling unrelated information and/or items; Inclusion of necessities; and Finally adaptation of their design and follow with the administrative procedures and require- ments of GMP, ISO, and Internal Design of organization. Importance of this principle has made it a feature and criteria of suitability of organizations by this formula:
Structure and efficiency of a well-designed organization,
And the competence of its creators ,
are defined in, and mirrored by its FORMS respectively.
(in other words: good FORMS are self-defining and the best guidance and MAP on your location in the organization.) Many forms by application of this principle were corrected.
21)Application of ‘USP Introduction’s recommendation, or what can be even interpreted as ORDER ,on the Necessity of Internalizing and Absorption of scientific basis of each test and monograph, proved that by simple translation of them into the mother-tongue of technicians and rewriting or typing them in a tidy format nearly Nothing of knowledge would be gained and no responsibility would be fulfilled, and brings not even a small portion of practical efficiency and expert: Any activity in the filed of application of Natural Sciences, in their most modern meaning of them, without bearing a Good and Deep understanding of their theoretical ground in mind, is Only and Only a ‘sleepwalking’ and sleepwalker fells and stops very soon by the first obstacle.
Some sample were done. All the above huge mistakes in analytical procedures and results were the fruits of ignorance to that order and its importance and were solved only ay its application. Those samples proved that in some cases the Supporting Information of an analysis could be up to ten times of its text and need a lot of references be used at the same time.
MORE POINTS ON PERSONAL INTERESTS:
1)My personal library has about three thousand volumes of books. They could be divided into two main category; first books on Human sciences and second those on Natural sciences. Some books in the former part have some applications on organizations and by this way find some links to environmental parameters of scientific
Of human society; for example principles of philosophy, psychology, sociology, management or even politics and some concepts of biology have strong applications in organizations and through this way could help in understanding of those specific problems which have been a constant part of human life in society and history.
2)My Natural Sciences books are on the subjects: Physics (as the king, head and spring of all other discipline in this field), Calculus, Linear Algebra, Geometry, Statistics, Pharmaceutical statistics, Statistical design, Thermodynamic, General chemistry, Organic chemistry, Inorganic chemistry, Medicinal chemistry, Pharmaceutical chemistry, Physical chemistry, Instrumental analytical chemistry, Unit operations in chemical engineering, Perry’s handbook of chemical engineering, Engineering and mechanical design, Industrial pharmacy(many), Pharmacology: Basic, Clinical, Molecular; Drug information, Internal medicine, Biopharmaceutics, Pharmacokinetics, Quality control, Statistical quality control, GMP regulations, and …
3)My Human sciences books on related fields to Organizations are on subjects: Sociology, Psychology, Social psychology, Management, Organizational Behavior,
Organization design, Ergonomy, Job design, ISO applications and …
4)My main interest is reading and reading and reading, and then Hiking, Photography, Handicraft, Persian Poem and Language and Vocabulary and Prose style; English language (more than two hundred books on different aspect of English language including about sixty volume monolingual English-English dictionaries of different kinds and size and publishers).
5)This letter is the example of my writing ability in English and, my speaking is nearly at the same level and I have no difficulty in reading, understanding and interpretation of scientific and pharmaceutical texts and references.
B Mohammad pour
Pharm. D.
May 2009
3&4- THE REPLIES OF "FDA" AND
RE: DrugInfo Comment Form FDA/CDER Site
Thu, May 21, 2009 1:34:23 PM
| From: |
CDER DRUG INFO <DRUGINFO@fda.hhs.gov>
| |
| To: | bmp1337@yahoo.com |
Dear B Mohammad pour:
Thank you for your message to the Center for Drug Evaluation and Research (CDER), one of the five centers within the Food and Drug Administration (FDA).
I am sorry, but we can not provide opinions or advice in this situation. We would suggest that you review our manufacturing regulations at the following link for guidance http://www.fda.gov/cder/dmpq/
Sincerely,
Division of Drug Information
D202D
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
RE: An Incredable Report From....a little pharmacist
Thu, June 25, 2009 5:20:33 PM
| From: |
MHRA Information Centre <info@mhra.gsi.gov.uk>
| |
| To: | bmp1337@yahoo.com |
Dear Mr B Mohammad pour,
Manufacturing sites in the UK and sites in countries that manufacture product for the UK are regularly inspected to ensure compliance to the
EU Good Manufacturing Practice Guidelines (GMP). If a site fails to meet applicable GMP standard then their license to manufacture pharmaceuticals can be varied or revoked.
If a site continues to manufacture (ie manufactures without a license and hence illegally) then Enforcement powers exist such that individuals in the UK can be prosecuted under the Medicines Act. The penalties applicable in such cases are 2 years imprisonment and/or unlimited fine.
We can not comment on what should or does happens in non EU countries if Good Manufacturing Practice is not adhered to.
Your sincerely
B J Wright Group Manager Inspection
Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000
Tel: 020 7084 2000
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