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Good Documentation Practice

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Good Documentation Practice (GDP) is a term in the pharmaceutical industry to describe standards by which documents are created and maintained. While some GDP 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 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.

Contents

[edit] GDP standards

[edit] Documentation creation

  • Contemporaneous with the event they describe[1][2][3][4]
  • Not handwritten (except for handwritten entries thereon)[1]
  • When electronically produced, the documentation must be checked for accuracy[1]
  • Free from errors[2][5]
  • For some types of data, the documentation must be in a format that permits trend evaluation[6]

[edit] Document approval

  • Approved, signed, and dated by appropriate authorized personnel [1][4][7]

[edit] Handwritten entries

  • Adequate space is provided for expected handwritten entries[1][3]
  • Handwritten entries are in indelible ink[1][3][4]
  • Critical entries must be independently checked (SPV, or second person verified)[1][7]
  • No spaces for handwritten entries are left blank - if unused, they are crossed out or "N/A" (or similar text) entered
  • Ditto marks or continuation lines are not acceptable[8]
  • A stamp in lieu of a handwritten signature is not acceptable

[edit] Copies of documents

[edit] Document maintenance

[edit] Document modification

  • Handwritten modifications are signed and dated[1][2][3][4]
  • Altered text is not obscured (e.g. no Wite-Out)[1][2][3][4]
  • Where appropriate, the reason for alteration must be noted[1][2][3][7] ("E.E." is a common abbreviated reason, indicating "Entry Error")
  • Controls exist to prevent the inadvertent use of superseded documents[1][3]
  • Electronic versions can only be modified by authorized personnel[1][2]
  • Access to electronic versions must be controlled by password or other means[1]
  • A history (audit trail) must be maintained of changes and deletions to electronic versions[1][2][4][5]

[edit] 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:

[edit] Use of ditto marks

  • US FDA Warning Letter FLA-99-29 to All Medicare Home Aids, Inc., January 28, 1999.[9]
  • US FDA Warning Letter 2008-DAL-WL-19 to Simmons Pet Food, Inc., July 23, 2008[10]

[edit] Use of signature stamp

  • US FDA Warning Letter UCM075960 to Scott A. Spiro, MD, 28-Jun-06.[11]
  • US FDA Warning Letter UCM066113 to Medtronic, Inc., DEC 2 1997.[12]

[edit] Obscured original data

  • US FDA Warning Letter 320-01-02 to SOL Pharmaceuticals Limited, NOV 21, 2000[13]

[edit] Use of pencil

  • US FDA Warning Letter 320-01-02 to SOL Pharmaceuticals Limited, NOV 21, 2000[13]

[edit] Inaccurate records

  • US FDA Warning Letter 320-01-02 to SOL Pharmaceuticals Limited, NOV 21, 2000[13]

[edit] References

  1. ^ a b c d e f g h i j k l m n o p q r s EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines. (Chapter 4)
  2. ^ a b c d e f g US FDA. "Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS" April 1999 - Accessed 04-Feb-2010
  3. ^ a b c d e f g h i WHO. TRS 908 "Good Manufacturing Practices for Pharmaceutical Products: Main Principle" (Annex 4, Section 15)
  4. ^ a b c d e f ICH. "Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients" (Section 6)
  5. ^ a b c d e f European Commission Directive 2003/94/EC. (Article 9)
  6. ^ a b EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines. (Chapter 6)
  7. ^ a b c d e 21CFR211 Subpart J
  8. ^ US FDA. "HUMAN DRUG CGMP NOTES" (Volume 8, Number 3) September, 2000
  9. ^ US FDA. "Warning Letter" FLA-99-29
  10. ^ US FDA. "Warning Letter" 2008-DAL-WL-19 - Accessed 04-Feb-2010
  11. ^ US FDA. "Warning Letter" UCM075960 - Accessed 04-Feb-2010
  12. ^ US FDA. "Warning Letter" UCM066113
  13. ^ a b c US FDA. "Warning Letter" 320-01-02
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