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.
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[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
[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
- Regularly reviewed and kept current[1][5]
- Retained and available for appropriate duration[1][5][6][7][9]
- Electronic document management systems are validated[5]
- Electronic records are backed up[1][5]
[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"[10][11])
- Controls exist to prevent the inadvertent use of superseded documents[1][3][9]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]
[edit] GDP Interpretation
From the regulatory guidance above, additional expectations or allowances can be inferred by extension. Among these are:
- Prohibition against removing pages[12] - The removal of a page would obscure the data that were present, so this is not permissible.
- Page numbering[12] - 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[12] - 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[12] - 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 an 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.[12] 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.
[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] Documentation not contemporaneous
- US FDA Warning Letter UCM172108 to Caraco Pharmaceutical Laboratories, Ltd. (Caraco), May 12, 2009 [13]
[edit] Use of ditto marks
- US FDA Warning Letter FLA-99-29 to All Medicare Home Aids, Inc., January 28, 1999.[14]
- US FDA Warning Letter 2008-DAL-WL-19 to Simmons Pet Food, Inc., July 23, 2008[15]
[edit] Use of signature stamp
- 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]
[edit] Obscured original data
- US FDA Warning Letter 320-01-02 to SOL Pharmaceuticals Limited, NOV 21, 2000[18]
- US FDA Warning Letter UCM076246 to Gynetics Medical Products NV, JAN 16 2007[19]
[edit] Use of pencil
- US FDA Warning Letter 320-01-02 to SOL Pharmaceuticals Limited, NOV 21, 2000[18]
[edit] Inaccurate records
- US FDA Warning Letter 320-01-02 to SOL Pharmaceuticals Limited, NOV 21, 2000[18]
[edit] Hand changes not dated
- Form FDA 483 issued to L. Perrigo Co., NOV 7, 2008.[20]
[edit] References
- ^ 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).
- ^ a b c d e f g US FDA. "Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS" April 1999 - Accessed 04-Feb-2010
- ^ a b c d e f g h i WHO. TRS 908 "Good Manufacturing Practices for Pharmaceutical Products: Main Principle" (Annex 4, Section 15)
- ^ a b c d e f ICH. "Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients" (Section 6)
- ^ a b c d e f European Commission Directive 2003/94/EC. (Article 9)
- ^ a b EudraLex - Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use. (Part I, Chapter 6 Quality Control, Revised 01-June-2006)
- ^ a b c d e 21CFR211 Subpart J
- ^ US FDA. "HUMAN DRUG CGMP NOTES" (Volume 8, Number 3) September, 2000
- ^ 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
- ^ GMP Quality Up. Example SOP "Laboratory Workbook" section 2.6 - Accessed 01-Jun-2011
- ^ US EPA Office of Pesticide Programs. SOP No. ADM-05-02 "Standard Operating Procedure for Use and Maintenance of Laboratory Notebooks and Project Binders" section 10.3.13 (Revised 11-03-10) - Accessed 01-Jun-2011
- ^ a b c d e Hurd, Don, et al. "Good Documentation Practices" (Copyright 2010, Premier Validation) ISBN 0111-2323232-44-5
- ^ Caraco Pharmaceutical Laboratories, Ltd. Response to the FDA's May 12, 2009, 483. Observation #14a - Accessed 01-Jun-2011
- ^ US FDA. "Warning Letter" FLA-99-29
- ^ US FDA. "Warning Letter" 2008-DAL-WL-19 - Accessed 04-Feb-2010
- ^ US FDA. "Warning Letter" UCM075960 - Accessed 04-Feb-2010
- ^ US FDA. "Warning Letter" UCM066113
- ^ a b c US FDA. "Warning Letter" 320-01-02
- ^ US FDA. "Warning Letter" UCM076246, Observation #13b. - Accessed 01-Jun-2011
- ^ US FDA. Form FDA 483 issued to L. Perrigo Co., dated 11/07/2008. Observation #9A
