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Pakistan DRAP Guidance: GMP for Manufacturing Sites of Drugs

Earlier today (09-January-2022), the Drug Regulatory Authority of Pakistan released an updated guidance on "Good Manufacturing Practices for Manufacturing Sites of Drugs".

The purpose of this guideline is to provide guidance on Good Manufacturing Practices (GMP) for pharmaceutical & biological drug manufacturing to ensure that:

  1. Products are consistently produced and controlled to the quality standards appropriate to their intended use

  2. Products are manufactured as required by the marketing authorization or product specification; and

  3. 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.

In order to ensure the quality of drug products and compliance with its Current Good Manufacturing Practices (cGMP), DRAP monitors the manufacturers to ensure that the facilities, methods, and controls used to manufacture, process, and pack a drug product comply with minimum requirements.

A harmonized approach to ensuring compliance with current GMP requirements is provided in this guidance document regarding aspects of GMP as specified by Schedule B-II of The Drugs Rules 1976.

Click this LINK to know more details on legal framework, considerations for implementation etc.


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