Good Documentation Practices in Pharmaceutical Industry

I n a Pharmaceutical industry, “If it isn’t documented, it didn’t happen”. Therefore, it is mandatory for every Pharmaceutical industry to maintain proper documentation and records. These documents are a reliable evidence for GMP compliance and acts as a tool for communication both internally and externally.

A Pharmaceutical Industry uses various documents. To name a few,

  • Master Filectives
  • Clinical Trial Reports
  • Specifications
  • Standard Operating Procedures
  • Test Methods
  • Work and General Instructions
  • Process and Method Validation
  • Batch Records
  • Policies
  • Check Lists
  • Instrumentation Records
  • Change Controls
  • Access Forms and many more

According to WHO the purpose of documentation is,

  • To define the specifications and procedures for all materials and methods of manufacture and control.
  • To ensure that all personnel concerned with manufacture know what to do and when to do it.
  • To ensure that authorized persons have all the information necessary to decide whether to release a batch or not.
  • To ensure the existence of documented evidence, traceability, and to provide records and an audit trial that will permit investigation.
  • To ensure the availability of the data needed for validation, review and statistical analysis.

Many pharmaceutical industries have received warning letters from FDA for not being compliant with Good Documentation Practices.
Some of the commonly faced documentation issues are:

  1. Missing Documents
  2. Falsified data
  3. Illegible data
  4. Missing Signature
  5. Documents with missing/false date, time and Version number, etc.

Consequences of these activities will lead to penalties and in some case, legal action against the organization. Following the GDP practices will ensure the quality standards and deliver of quality products to the consumers.