On Thursday, May 21, 2009 1:37 PM, CDER DRUG INFO <druginfo@fda.hhs.gov> wrote:
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.
-----Original Message-----
From: druginfo@fda.hhs.gov [mailto:druginfo@fda.hhs.gov]
Sent: Monday, May 18, 2009 9:49 PM
To: CDER DRUG INFO
Subject: DrugInfo Comment Form FDA/CDER Site
Name: mohammadpou, bagher
E-Mail: bmp1337@yahoo.com
Comments: Dear Madam Sir
I am an Iranian pharmacist with more than 20 years of experience in the pharmaceutical industries of Iran.
The following list is not a sample, it shows the NATURE of nearly all activities which are needed to be done in a typical pharmaceutical company to be a pharmaceutical company, in nearly all domestic manufacturers of medicinals. As a colleague of you from a remote country, I like to know professional, scientific, and legal assessment and evaluation of Pharmacy, as an established international discipline, on them and that National System (including Ministry of Health) which supports them. You do not need here to hear more and again why no one dares to speak of this kind of problems in Iran. What would be the consequences of such mistakes in Europe or the North America, according to current law and regulations for such manufactures and officials?
�- 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.
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 hear from you as soon as possible. Your favor would not be forgotten and I am in need of your guidance.
Faithfully your
B Mohammad pour,
Pharm. D.
bmp1337@yahoo.com
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