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 and medical device industries 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. the reasons of documentation Permanent traceable record. Consistent training. Consistent control over the operation. Regulatory authority. Control of deviation

GDP / GDocP standards

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

Document approval

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

Handwritten entries

• 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]
• Correction fluid are not allowed to be used in correcting errors

• A stamp in lieu of a handwritten signature is not acceptable

Copies of documents

• Clear, legible[1][3][9]
• Errors are not introduced[1][3][7]

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]

Document modification

• 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

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 GDocP 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

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

• US FDA Warning Letter 320-11-20 (UCM271708) to Yag-Mag Labs Private Limited (Hyderabad, India), 12 September 2011 [11]
• US FDA Warning Letter UCM172108 to Caraco Pharmaceutical Laboratories, Ltd. (Caraco), 12 May 2009 [12]
• US FDA Warning Letter UCM076496 to Kunshan Chemical and Pharmaceutical Co., Ltd. (Kunshan City, Jiangsu, China), 6 September 2007 [13]
• US FDA Warning Letter UCM075472 to Litron Laboratories, Ltd. (Rochester, NY), 1 July 2005 [14]

Use of ditto marks

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

Use of signature stamp

• US FDA Warning Letter UCM075960 to Scott A. Spiro, MD, 28 June 2006.[16]
• US FDA Warning Letter UCM066113 to Medtronic, Inc., 2 December 1997[17]

Obscured original data

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

Use of pencil

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

Inaccurate records

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

Hand changes not dated

• Form FDA 483 issued to L. Perrigo Co., 7 November 2008.[21]

See also

• Best practice
• Good manufacturing practice
• Site master file (pharmaceuticals)

References

1. EudraLex - Volume 4, Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use (Chapter 4: Documentation, Revision 1).
2. US FDA. "Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS" April 1999 - Accessed 4 February 2010
3. WHO. TRS 961 "Good Manufacturing Practices for Pharmaceutical Products: Main Principles" 2011 (Annex 3, Section 15)
4. ICH. "Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients" (Section 6)
5. European Commission Directive 2003/94/EC. (Article 9)
6. "Part I, Chapter 6 Quality Control" (pdf), The rules governing medicinal products in the European Union, Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use., 1 June 2006, p. 3
7. 21CFR211 Subpart J
8. US FDA. "HUMAN DRUG CGMP NOTES" (Volume 8, Number 3) September, 2000
9. 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) Archived 22 July 2011 at the Wayback Machine - Accessed 7 January 2011
10. 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 November 2012
11. US FDA. "Warning Letter" UCM271708. Observation #1 - Accessed 27 June 2013
12. Caraco Pharmaceutical Laboratories, Ltd. Response to the FDA's May 12, 2009, 483. Observation #14a - Accessed 1 June 2011
13. US FDA. "Warning Letter" UCM076496. Observation #1 - Accessed 16 August 2012
14. US FDA. "Warning Letter" UCM075472 . Observation #4 - Accessed 16 August 2012
15. US FDA. "Warning Letter" FLA-99-29
16. US FDA. "Warning Letter" UCM075960 - Accessed 4 February 2010
17. US FDA. "Warning Letter" UCM066113
18. US FDA. "Warning Letter" UCM069041
19. US FDA. "Warning Letter" UCM076246, Observation #13b. - Accessed 1 June 2011
20. US FDA. "Warning Letter" UCM221006. Observation #7.b. - Accessed 16 August 2012
21. US FDA. Form FDA 483 issued to L. Perrigo Co., dated 11/07/2008. Observation #9A