Common Guidelines for Good Documentation Practices

 Good documentation practices (GDP) are essential in ensuring the integrity, traceability, and reliability of data and information in regulated industries, such as pharmaceuticals, medical devices, and biotechnology. The following are some common guidelines for good documentation practices:

  1. Write legibly: All entries should be clear and legible. Avoid using abbreviations or acronyms that are not well-known or may be easily confused.

  2. Use permanent ink: All entries should be made in permanent ink (e.g. black or blue ink).

  3. Date and sign: All entries should be dated and signed, including corrections and additions.

  4. Follow standard operating procedures (SOPs): All documentation should follow the relevant SOPs, including templates, formats, and requirements for documentation.

  5. Document everything: All critical information related to the process, such as the materials used, equipment calibration, environmental conditions, and test results, should be recorded in a timely and accurate manner.

  6. Use approved forms and documents: All documentation should use approved forms and documents, and all changes should be properly authorized and documented.

  7. Keep records organized: All records should be organized and stored in a secure and easily retrievable manner, with appropriate backups and retention periods.

  8. Avoid blank spaces: All documentation should be completed at the time of the activity, and any blank spaces should be crossed out with a single line, initialed, and dated.

  9. Use good documentation practices in electronic systems: Good documentation practices apply to electronic systems as well, and these systems should be validated, secure, and have appropriate access controls and audit trails.

Adherence to good documentation practices is critical in regulated industries to ensure compliance with regulatory requirements and to maintain the safety, efficacy, and quality of products and processes.


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