To ensures the quality of drugs and compliance with its Current Good Manufacturing Practice (cGMP), DRAP monitor 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 Good Manufacturing Practices are intended to make sure that a product is safe for use, and meet the prescribed standard of quality.
Although the Drugs (Licensing, Registering & Advertising) Rules, 1976 under the Drugs Act, 1976 provides detail requirements on Good Manufacturing Practices (GMP), however, DRAP intended to provide a compiled GMP guidance document stipulating Drug Regulatory Authority of Pakistan’s (DRAP) expectations on GMP from pharmaceutical & biological drugs manufacturers.
This Guideline is intended to provide guidance regarding the Good Manufacturing Practices (GMP) for the manufacturing of pharmaceutical & biological drug in accordance with the Drugs (Licensing, Registering & Advertising) Rules, 1976, under the Drugs Act, 1976, the good manufacturing practices aim at ensuring that:
- Products are consistently produced and controlled to the quality standards appropriate to their intended use
- Products are manufactured as required by the marketing authorization 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 final products.
This document will help industry and Regulators to conform the requirement of GMP for production, verification, and validation of manufactured products and ensure that they are effective and safe.