SA: GMP "Not Enough" To Assure Quality Generics

good manufacturing Practices and routine quality control will not be enough to assure the quality of interchangeable multi-source pharmaceutical products (IMPP) in future, the Southern African Pharmaceutical Regulatory Affairs Association conference heard (Marketletter March 27). Tough inspection procedures will be crucial, because an applicant's ability to manufacture drugs within a tightly-controlled environment is essential if IMPPs are to remain reproducible and efficacious, said Johann Schlebusch, South Africa's Registrar of Medicines.

Over the past three years, the number of new drug applications has gone up 75%, against a norm established over 23 years, said Prof Schlebusch. Most of these are IMPP applications from new players in the field of industrial pharmacy, and due to the worldwide swing to IMPP, many small, inexperienced companies are acting as applicants and will ultimately oversee the production and quality assurance of IMPPs. Appropriate action has to be taken in time, he told the meeting.

This is why he does not agree with the statement made at the African Drug Regulatory Authority conference in Berlin in April 1994, that "in order to promote faster procedures for the registration of essential drugs, the drug regulatory authority should concentrate on GMP of the manufacturer and quality control of the product." The World Health Organization recommends in vitro/in vivo testing when significant post-marketing changes are made, ie to formulation, site or process of manufacture, etc. But GMP companies generally prefer to speak of "validation," required when a new formula, method of preparation or significant amendment is made to manufacturing aspects which may affect quality or reproducibility.