On Saturday, January 22, 2011 1:51 PM, "Postmaster@hc-sc.gc.ca" wrote:
----- Forwarded Message -----
Your message Subject: "Re: providing you more evidence" was not delivered to: no_reply-ne_pas_repondre@hc-sc.gc.ca because:
FROM MY CV
I believe that you mention this letter and its content Strictly confidential and professional as your reply would be considered so.
Thank you for your attention, time and kindness. I am eagerly looking forward to hearing from you as soon as possible. Your favour would not be forgotten and I am in grat need of your guidance.
Faithfully your
B Mohammad pour,
Pharm. D.
bmp1337@yahoo.com
From: GMP_Questions_BPF
To: bagher mohammadpour
Sent: Thu, January 20, 2011 2:19:59 PM
Subject: Re: From an Iranian pharmacist
(le français suit)
Thank you for contacting the Drug Good Manufacturing Practices (GMP) Inspection Unit of Health Canada.
We aim to answer your questions as quickly as possible. If your inquiry is more complex or requires input from a technical committee, our response time will be longer.
Your message has been forwarded to a knowledgeable member of our staff for consideration and response.
If you do not hear from us in 20 working days, please feel free to inquire as to the status of your initial request.
Should you have any further questions related to GMP, please do not hesitate to contact the Drug GMP Inspection Unit at
Drug Good Manufacturing Practices Unit
Health Products and Food Branch Inspectorate
Health Canada
250 Lanark Avenue
Ottawa, Ontario
K1A 0K9
Tel: 613-957-1492
Fax: 613-957-6709
gmp_questions_bpf@hc-sc.gc.ca
Sincerely,
The Drug Good Manufacturing Practices (GMP) Inspection Unit
Nous vous remercions d’avoir contacté l’Unité d’inspection des bonnes pratiques de fabrication (BPF) des médicaments de Santé Canada.
Nous tentons de répondre à vos questions le plus rapidement possible. Cependant, nos délais peuvent être plus longs si votre question est plus complexe ou nécessite l'avis de notre comité technique.
Nous avons fait parvenir votre message à un membre bien renseigné de notre personnel, afin qu’il l’étudie et y réponde.
N'hésitez pas à communiquer avec nous si vous ne recevez pas une réponse dans 20 jours ouvrables.
Si vous avez toute autre question reliée aux BPF, veuillez ne pas hésiter à communiquer avec l’Unité d’Inspection BPF des médicaments, aux coordonnées suivantes:
Santé Canada
Inspectorat de la Direction générale des produits de santé et des aliments
Unité d'inspection des bonnes pratiques de fabrication des médicaments
250, avenue Lanark
Ottawa (Ontario)
K1A 0K9
Tél: 613-957-1492
Télecopieur: 613-957-6709
gmp_questions_bpf@hc-sc.gc.ca
Veuillez agréer nos sincères salutations,
L’Unité d’Inspection bonnes pratiques de fabrication (BPF) des médicaments
Your message Subject: "Re: providing you more evidence" was not delivered to: no_reply-ne_pas_repondre@hc-sc.gc.ca because:
Delivery time expired
Dear Madam/Sir
Thank you for your prompt reply. I know that this kind of requests
may take some time to reply more than usual matters but the main problem
with me and this case is that I am in an extremely bad situation and
may be not able to wait for about three weeks. Hereby I intend to
request if possible inform me sooner; It is a vital and crucial matter
to me. To provide you more evidence on the importance of the matter and
making the assessment of request easier,I send you more information from
my CV on similar problems.
I hope to receive your reply in the first few days of next week.
Faithfully yours
B Mohammadpour
And here are more cases taken from my CV:
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.
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.
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.
I believe that you mention this letter and its content Strictly confidential and professional as your reply would be considered so.
Thank you for your attention, time and kindness. I am eagerly looking forward to hearing from you as soon as possible. Your favour would not be forgotten and I am in grat need of your guidance.
Faithfully your
B Mohammad pour,
Pharm. D.
bmp1337@yahoo.com
From: GMP_Questions_BPF
To: bagher mohammadpour
Sent: Thu, January 20, 2011 2:19:59 PM
Subject: Re: From an Iranian pharmacist
(le français suit)
Thank you for contacting the Drug Good Manufacturing Practices (GMP) Inspection Unit of Health Canada.
We aim to answer your questions as quickly as possible. If your inquiry is more complex or requires input from a technical committee, our response time will be longer.
Your message has been forwarded to a knowledgeable member of our staff for consideration and response.
If you do not hear from us in 20 working days, please feel free to inquire as to the status of your initial request.
Should you have any further questions related to GMP, please do not hesitate to contact the Drug GMP Inspection Unit at
Drug Good Manufacturing Practices Unit
Health Products and Food Branch Inspectorate
Health Canada
250 Lanark Avenue
Ottawa, Ontario
K1A 0K9
Tel: 613-957-1492
Fax: 613-957-6709
gmp_questions_bpf@hc-sc.gc.ca
Sincerely,
The Drug Good Manufacturing Practices (GMP) Inspection Unit
Nous vous remercions d’avoir contacté l’Unité d’inspection des bonnes pratiques de fabrication (BPF) des médicaments de Santé Canada.
Nous tentons de répondre à vos questions le plus rapidement possible. Cependant, nos délais peuvent être plus longs si votre question est plus complexe ou nécessite l'avis de notre comité technique.
Nous avons fait parvenir votre message à un membre bien renseigné de notre personnel, afin qu’il l’étudie et y réponde.
N'hésitez pas à communiquer avec nous si vous ne recevez pas une réponse dans 20 jours ouvrables.
Si vous avez toute autre question reliée aux BPF, veuillez ne pas hésiter à communiquer avec l’Unité d’Inspection BPF des médicaments, aux coordonnées suivantes:
Santé Canada
Inspectorat de la Direction générale des produits de santé et des aliments
Unité d'inspection des bonnes pratiques de fabrication des médicaments
250, avenue Lanark
Ottawa (Ontario)
K1A 0K9
Tél: 613-957-1492
Télecopieur: 613-957-6709
gmp_questions_bpf@hc-sc.gc.ca
Veuillez agréer nos sincères salutations,
L’Unité d’Inspection bonnes pratiques de fabrication (BPF) des médicaments
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