DRAP’s document on guidelines for manufacturers

KARACHI: The Drug Regulatory Authority of Pakistan (DRAP) has issued a consolidated guidance document for drug manufacturers to ensure the quality of drugs and compliance with its Current Good Manufacturing Practices (CGMPs).

DRAP monitors the manufacturers to ensure compliance to minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. These protocols are intended to make sure that a product is safe for use, and meets the prescribed standards of quality.

Although the Drugs (Licensing, Registering & Advertising) Rules, 1976 under the Drugs Act, 1976, provide detailed requirements on the CGMPs, Drap intended to provide compiled guidelines in the form of a document for the pharmaceutical and biological drugs manufacturers.

Through these guidelines, DRAP wants to ensure that the products are consistently produced and controlled to the quality standards appropriate to their intended use; they are manufactured as required by the marketing authorisation or product specification  and all those risks have been diminished that are inherent in any pharmaceutical / biological production operation, including contamination, cross contamination and mix-ups (confusion), that cannot be detected completely through the testing of the final products.

This document will help the industry as well as the regulators to conform to the requirement of GMP for production, verification, and validation of the manufactured products and ensure that they are effective and safe.