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Good Manufacturing Practice in Pharmaceuticals

The Cost of Quality Control Cannot be the Lives of Citizens

by Gerhard G. Doege
THE recent Issue on paracetamol syrup and the suspicion or fact of its containing dicthylenc glycol. which, according to the Merck Index" and "Martindale'' is highly toxic for human consumption, prompt us to pay serious attention to the following facts:
THE MANUFACTURING LICENCE: Any company who wants to manufacture drugs in Bangladesh must obtain a manufacturing licence. Before the Drug Administration issues this licence ft inspects the premise and satisfies'itself that building, equipment Including Quality Control allows a 'to the state-of-the-art production'. The manufacturing licence number Is to be printed on the labcl/blister/strlp of each drug.
RESPONSIBLE
PHARMACIST: In order to obtain the above licence one has to nominate a registered pharmacist including his credentials. A pharmacist knows very well which chemicals to use, which ones not.
TESTING OF RAW MATERIALS: Each and every raw material, whether active substance or auxiliary, entering
the company must be labelled "Quarantine" on each container, i.e. it can not yet be used for production.
Each and every container must be analyzed on the basis of "analytical methods" and Its standard requirements.
A random testing of entry material from "approved suppliers" is not to the state-of-the-art. Approved suppliers only minimize the risk of a failure but one never can shift the manufacturing liability to the fact that the material came from an "approved" supplier.
Only after satisfactoiy Quality Control each and every container of raw material is labelled "Released" and can be used for production. Sample and QC-Certificate of each test must be kept for 12 years for all documents, 7 years for ail samples.
Each manufactured batch of a drug gets a number and Is accompanied by In-process controls in each production step with clearly determined tests and standard requirements. Documents are kept 12 years!
The final release of a batch Is testified with a QC-
Certificate which again shows standard requirements and findings. Only after all these above "quality assurance' mca sures a batch can be sold.
Samples of finished goods of each batch must be- kept for 7 years! In the present case It should be easy to prove the "Good Manufacturing Practice (GMP)" out of these samples. Exactly for such a case they have to be kept.
Are they available?
QUALITY CONTROL , EQUIPMENT: Pbr each and every raw material, whether active substance or auxiliary, there is a specification and quality control — "Method of Analysis".
Each test requires a certain set of instruments and apparatus.
If any material needs a ccr lain apparatus, c.g. a gaschromatograph and a manufacturer wants to produce and market a product containing such a material then he either must have this equipment or cannot market such a product if he docs not invest into appropriate quality control
equipment.
A gas-chromatograph costs Tk. 2,000,000 (USD 55.000) and many of our drugs arc sold at a fraction of a Taka only!
However, the cost of quality control cannot be the lives of citizens!
CONCLUSION: The above facts show that our Drug Administration has a strong role in assuring one quality of drugs. There Is no room for any compromise, it docs not allow an "acceptable" qualify even (what Is that and for whom?)
It is cither quality or nonquality. The definition of Quality is: The continuous conformance with agreed upon standards. Below the standards is substandard, above the standards is luxury.
When a present "Drug Policy" says: same sub-stancc/samc price and completely dentes — therapeutic differences: production technology differences; quality assurance differences.
how can different quality
standards be allowed.
Our Deputy Leader of the House, Prof Badruddoza Chowdhury rightly said recently In a workshop on treatment of tuberculosis: "Every citizen has the right for the best available treatment, second class drugs arc not acceptable."
Even though it is the Drug Administration to licence or to close drug companies it strongly needs the subscription of each manufacturer to "Good Manufacturing Practice (GMP)" and self-responsibility whenever the medical profession shall rely on drugs to be prescribed.
The Manufacturers Association (BASS) is supposed to be the forum to monitor the reliability of Its members. Right now any company can become a member against Taka lOOO/p.a. without fulfillment of any pre-requtsitc.
When Bangladesh wants to get out of the bad reports of any World Health Assembly (WHA) in Geneva. the Manufacturers Association shall screen members according to GMP.
Bangladesh is not yet u
member of the International Federation as It does not comply with the most basic GMP-rules. But this must become our target. The present president of the association Mr Salman F Rahman takes courageous and entrepreneurial steps to achieve this target. He deserves followers and support.
CONSEQUENCES: The production of drugs (at low standards) cannot be a vehicle for profit only rather a manufacturer of drugs contributes also to our health care system with reliable drugs.
The production of reliable quality drugs needs a fair price taking into consideration the facts which are mentioned above. Otherwise, the triangle of quality, Cost and Price comes Into conflict — in our country too many times at the detriment of quality and patients. Our present pricing policy docs not take into account these GMP aspects but compromises on’quality. Is this in the Interest of our citizens?
The writer Is Managing Director. Ctba-Geigy (Bangladesh) lad.