UMKU PB Details

Requirements

1. Standards and Requirements for Good Manufacturing Practice Certification

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2. Good Manufacturing Practice Standards based on examination by the agency responsible for government affairs in the field of drugs and food control

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3. Requirements for Good Manufacturing Practice Certification

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4. Good Manufacturing Practice Standards

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Responsibilities

1. Comply with Good Manufacturing Practice Standards during production activities

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2. Report production activities to the head of the agency responsible for government affairs in the field of drugs and food control, including:
   1. Reports on the import and use of Active Pharmaceutical Ingredients (API), drug production and distribution, API production and distribution, export and import of drugs and API;
   2. Reports on the import and use of API, drug production and distribution, API production and distribution, for Narcotics, Psychotropics, Pharmaceutical Precursors, and Specific Drugs;
   3. Reports on the realization of drug and API exports and imports for Narcotics;
   4. Reports on the realization of drug and API exports and imports for Psychotropics and/or Pharmaceutical Precursors;
   5. Pharmaceutical Industry master data reports containing information/profiles of the pharmaceutical industry, including production activities and production equipment used.

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3. Report the master documents of the pharmaceutical industry

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