Good documentation practice

Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical industry to describe standards by which documents are created and maintained. While some GDP / GDocP standards are codified by various competent authorities, others are not but are considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or adopt guidelines, and they may include non-codified GDP / GDocP expectations. While not law, authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers.

GDP / GDocP standards

Documentation creation

Document approval

Handwritten entries

Copies of documents

Document maintenance

Document modification

GDP / GDocP Interpretation

From the regulatory guidance above, additional expectations or allowances can be inferred by extension. Among these are:

Enforcement

The competent authorities are empowered to inspect establishments to enforce the law and the interpretations of the law (e.g., the content of guidance documents and the cGMPs). Here are some examples where such enforcement has occurred that included departures from GDP:

Documentation not contemporaneous

Use of ditto marks


Use of signature stamp

Obscured original data

Use of pencil

Inaccurate records

Hand changes not dated

References

  1. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 EudraLex - Volume 4, Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use (Chapter 4: Documentation, Revision 1).
  2. 1 2 3 4 5 6 7 US FDA. "Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS" April 1999 - Accessed 04-Feb-2010
  3. 1 2 3 4 5 6 7 8 9 WHO. TRS 961 "Good Manufacturing Practices for Pharmaceutical Products: Main Principles" 2011 (Annex 3, Section 15)
  4. 1 2 3 4 5 6 ICH. "Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients" (Section 6)
  5. 1 2 3 4 5 6 European Commission Directive 2003/94/EC. (Article 9)
  6. 1 2 "The rules governing medicinal products in the European Union", EudraLex (pdf), Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use., Revised 01-June-2006, p. 3 Check date values in: |date= (help); |chapter= ignored (help)
  7. 1 2 3 4 5 21CFR211 Subpart J
  8. US FDA. "HUMAN DRUG CGMP NOTES" (Volume 8, Number 3) September, 2000
  9. 1 2 3 Japan MHLW. Ministerial Ordinance No. 169, 2004, "Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostic Reagents" (Chapter 2, Section 2, Article 8, Paragraphs 2 and 4) - Accessed 07-Jan-2011
  10. 1 2 3 4 5 Hurd, Don (2010), Good Documentation Practices (PDF), et al., Premier Validation, pp. 11,17,30,39, ISBN 978-1-908084-00-2, archived (PDF) from the original on 13 Nov 2012
  11. US FDA. "Warning Letter" UCM271708. Observation #1 - Accessed 27-Jun-2013
  12. Caraco Pharmaceutical Laboratories, Ltd. Response to the FDA's May 12, 2009, 483. Observation #14a - Accessed 01-Jun-2011
  13. US FDA. "Warning Letter" UCM076496. Observation #1 - Accessed 16-Aug-2012
  14. US FDA. "Warning Letter" UCM075472 . Observation #4 - Accessed 16-Aug-2012
  15. US FDA. "Warning Letter" FLA-99-29
  16. US FDA. "Warning Letter" UCM075960 - Accessed 04-Feb-2010
  17. US FDA. "Warning Letter" UCM066113
  18. 1 2 3 US FDA. "Warning Letter" UCM069041
  19. US FDA. "Warning Letter" UCM076246, Observation #13b. - Accessed 01-Jun-2011
  20. US FDA. "Warning Letter" UCM221006. Observation #7.b. - Accessed 16-Aug-2012
  21. US FDA. Form FDA 483 issued to L. Perrigo Co., dated 11/07/2008. Observation #9A
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