Documentation In Pharma Industry

Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized. It consequently strengthens the quality, and its consistency of all goods and services, as those responsible for the specific operations have clear, unambiguous instructions to follow including active drug substances, is legally mandatory.

To define the specifications  and procedures for all materials and method of manufacture and control. To ensure that all personal concern with manufacture know what to do and when to do it. To ensure that authorized persons have all the information necessary to decide whether or not to realize a batch of a drug it ensures the availability of the data needed for validation, review and statistical analysis.The pharmaceutical Industry is heavily dependent on the development of new molecules to replace the revenue stream of older drugs that have come to the expiration of their patent terms.

  • GMP/GCP Documentation
  • BMR/BPR
  • Quality Assurance Documentation
  • Quality Control Documentation

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