In Process Quality Control in the Manufacture of Essential Drugs

Abstract

During the Thirty First World Health Assembly of the World Health Organization, Resolution WMA 31.32 on the Action Programme on Essential Drugs which recognized the importance of an adequate supply of essential drugs and vaccines to meet the real health needs of people living in developing countries was passed. The resolution also recognized the legitimate aspiration of developing countries to establish local production of those essential drugs wherever feasible.

In implementing the resolution, the WHO has called a meeting of its Expert Committee on the Selection of Essential Drugs in October 1977. The report of that Meeting resulted in a model list of essential drugs which appeared in the WHO Technical Report Series 615.

Continuing its efforts to fully implement WHA 31.32, the WHO has called the Meeting on Drug Policies: formulation and dosage forms and in-process quality control of essential drugs in developing countries in April 1979. The meeting discussed recommendations on criteria for the development of formulation, packaging and in-process quality control for the local manufacture of essential drugs including problems which may be encountered in local conditions.

The present paper which was presented at the Arpil 1979 meeting, discusses the importance of and recommends guidelines for in-process quality control, discusses problems which are anticipated and suggests solutions in the manufacture of drug products in small and medium scale formulation plants.

The paper cites the potential of drugs to cause serious injury/death, the inadequacy of sampling plans, the need for and an explanation of validation of critical steps in the manufacturing process and methods for assurance of quality. The paper classifies the list of essential drugs into seven categories based on complexity of manufacturing and discusses suggestions on how to initiate and maintain cost effective indigenous pharmaceutical manufacturing including a scheme of complementary/cooperative activities within and among nations in a region, “turn key” type contracts for facilities, personnel training, and the acquisition of manufacturing and control of manufacturing technology through purchase/licensing.