India Releases Draft Guideline on GDP for Pharmaceuticals

The Indian regulatory authority CDSCO (Central Drugs Standard Control Organization) has published a 21-page draft on GDP for pharmaceutical products. The objective of the guidelines is to ensure the quality and identity of pharmaceutical products during all aspects of the distribution process. These aspects include e.g. procurement, purchasing,...

The Indian regulatory authority CDSCO (Central Drugs Standard Control Organization) has published a 21-page draft on GDP for pharmaceutical products.

The objective of the guidelines is to ensure the quality and identity of pharmaceutical products during all aspects of the distribution process. These aspects include e.g. procurement, purchasing, storage, distribution, transportation, documentation and record-keeping practices.

The draft covers the topics well known from other GDP guidelines. Here are some of the requirements:

  • Each company must hold one person responsible for ensuring a quality system is implemented and maintained.
  • All distributors of pharmaceutical products have to establish and maintain a quality system supported by a documented quality system.
  • Senior management has to ensure that all parts of the quality system are adequately resourced with competent personnel and suitable and sufficient premises, equipment and facilities.
  • Pharmaceutical products should be traceable over the full length of the supply chain, from manufacturer to retailer, using the available documentation.
  • All documents have to be retained until one year after the expiry date of the product they relate to.
  • The management of recalls has to be laid down in a written procedure and a designated responsible person has to be appointed.
  • Spurious pharmaceutical products have to be completely segregated from other pharmaceutical products, clearly labeled as not for sale and national regulatory authorities and manufacturer of the original product must be informed immediately.
  • A designated, competent person shall conduct self-inspection in an independent and detailed way.

Stakeholders are requested to forward their comments within the next three weeks.

Source:

CDSCO: Notice on GDP-Draft Guideline

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