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News about GMP/cGMP

2016-10-21

CFDA: Draft Guidance on Data Management

According to RAPS, the CFDA (Chinese Food and Drug Administration) has released a draft guidance on drug data management practices. The paper is addressed to manufacturers, developers and distributors of pharmaceutical products and aims at an accurate, timely and traceable recording of data.

 

The focus of the document lies on:

  • The need for senior management to establish a “Quality Culture” that values data integrity
  • Structures and procedures that identify risk to data integrity
  • The investigation of potential violations in line with deviation handling procedures
  • Training of personal in data reliability
  • Establishment of a system that limits the potential for individuals for any data fraud
  • A signature-system to support data identification
  • A traceability system
  • Audit trail requirements.

The draft document is avialable in Chinese only.

Source:

RAPS: Regulatory Roundup

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