Good Documentation Practice

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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[edit]

Documentation creation[edit]

  • 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, it is recommended that records are in a format that permits trend evaluation[6]

Document approval[edit]

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

Handwritten entries[edit]

  • Adequate space is provided for expected handwritten entries[1][3]
  • Handwritten entries are in indelible ink[1][3][4]
  • Errors (i.e. misspelling, illegible entries, etc.) are corrected and reason is documented
  • 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

Copies of documents[edit]

Document maintenance[edit]

Document modification[edit]

  • Handwritten modifications are signed and dated[1][2][3][4]
  • Altered text is not obscured (e.g., no correction fluid)[1][2][3][4]
  • Where appropriate, the reason for alteration must be noted[1][2][3][7]
  • Controls exist to prevent the inadvertent use of superseded documents[1][3][9]
  • 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]
  • Supporting documents can be added to the original document as an attachment for clarification or recording data. Attachments should be referenced at least once within the original document. Ideally, each page of the attachment is clearly identified (i.e. labeled as "Attachment X", "Page X of X", signed and dated by person who attached it, etc.)

GDP / GDocP Interpretation[edit]

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

  • Prohibition against removing pages[10] - The removal of a page would obscure the data that were present, so this is not permissible.
  • Page numbering[10] - the addition of page numbers, particularly in "Page x of y" format, allows a reviewer to ensure that there are no missing pages.
  • Stamped signatures in Asia - the culture of certain Asian countries, and the controls they employ, are such that their use of a stamp in lieu of handwritten signatures has been accepted.
  • Date and time formats[10] - dates may be written in a variety of formats that can be confusing if read by personnel with a different cultural background. In the context where different cultures interact, a date such as "07-05-10" can have numerous different meanings and therefore, by GDP standards above, violates the requirement for being clear.
  • Transcription[10] - A transcription of data, where the original document is not retained, effectively obscures the original data and would be prohibited. Transcription may be helpful where the original is of poor quality writing or is physically damaged, but it should be clearly marked as a transcription and the original retained nevertheless.
  • Scrap paper, Post-it notes - Intentionally recording raw data on non-official records is a set-up for transcription and is therefore prohibited.
  • Avoiding asterisks as part of the notation of a hand-change - Where insufficient white space permits a fully notated hand change, a common practice is to use an asterisk (or other mark) near the correction, and elsewhere record the same mark and the notation. The risk is that additional changes are made by another person who uses the same mark, and now the notation can be interpreted to apply to all changes with the mark. Some will therefore advise against the use of the asterisk.[10] Others will accept it, if the notation clearly includes the number of changes that it applies to, such as, "* Three entries changed above due to entry errors. KAM 13-Jan-2011". There are no known instances of an agency rejecting such a notation.

Enforcement[edit]

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[edit]

  • US FDA Warning Letter 320-11-20 (UCM271708) to Yag-Mag Labs Private Limited (Hyderabad, India), Sep 12, 2011 [11]
  • US FDA Warning Letter UCM172108 to Caraco Pharmaceutical Laboratories, Ltd. (Caraco), May 12, 2009 [12]
  • US FDA Warning Letter UCM076496 to Kunshan Chemical and Pharmaceutical Co., Ltd. (Kunshan City, Jiangsu, China), Sep 06 2007 [13]
  • US FDA Warning Letter UCM075472 to Litron Laboratories, Ltd. (Rochester, NY), Jul 01, 2005 [14]

Use of ditto marks[edit]

  • US FDA Warning Letter FLA-99-29 to All Medicare Home Aids, Inc., January 28, 1999.[15]


Use of signature stamp[edit]

  • US FDA Warning Letter UCM075960 to Scott A. Spiro, MD, 28-Jun-06.[16]
  • US FDA Warning Letter UCM066113 to Medtronic, Inc., DEC 2 1997[17]

Obscured original data[edit]

  • US FDA Warning Letter UCM069041 to SOL Pharmaceuticals Limited, NOV 21, 2000[18]
  • US FDA Warning Letter UCM076246 to Gynetics Medical Products NV, JAN 16 2007[19]

Use of pencil[edit]

  • US FDA Warning Letter 320-01-02 to SOL Pharmaceuticals Limited, NOV 21, 2000[18]
  • US FDA Warning Letter UCM221006 to Haw Par Healthcare Limited (Singapore), July 20, 2010[20]

Inaccurate records[edit]

  • US FDA Warning Letter 320-01-02 to SOL Pharmaceuticals Limited, NOV 21, 2000[18]

Hand changes not dated[edit]

References[edit]

  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, Medicinal Products for Human and Veterinary Use (Chapter 4: Documentation, Revision 1).
  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 961 "Good Manufacturing Practices for Pharmaceutical Products: Main Principles" 2011 (Annex 3, 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 Part I, Chapter 6 Quality Control, (pdf), "The rules governing medicinal products in the European Union", EudraLex, Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use., Revised 01-June-2006: 3 
  7. ^ a b c d e 21CFR211 Subpart J
  8. ^ US FDA. "HUMAN DRUG CGMP NOTES" (Volume 8, Number 3) September, 2000
  9. ^ a b c 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. ^ a b c d e Hurd,, Don (2010), Good Documentation Practices, et al., Premier Validation, ISBN 01112323232445 Check |isbn= value (help) [page needed]
  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. ^ a b c 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