Good documentation practice: Difference between revisions

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{{Short description|Document standards in pharmaceutical and medical device industry}}

{{Use dmy dates|date=April 2017}}

'''Good documentation practice''' (commonly abbreviated '''GDP''', recommended to abbreviate as '''GDocP''' to distinguish from "good [[drug distribution|distribution]] practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which [[document]]s are created and maintained. While some GDP / GDocP standards are [[Codification (law)|codified]] by various [[Competent authority|competent authorities]], others are not but are considered [[Good manufacturing practice|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.

== GDocP standards ==

=== Documentation creation ===

* Contemporaneous with the event they describe<ref name=EUGMP4 />{{Rp|___location=¶4.8}}<ref name="FDAGCP">{{HHS content|source={{Cite web |date=April 1999 |title=Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS |url=https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/guidance-industry-computerized-systems-used-clinical-trials |url-status=livedead |archive-url=https://web.archive.org/web/20200924221420/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/guidance-industry-computerized-systems-used-clinical-trials |archive-date=24 September 2020 |access-date=15 October 2022 |website=U.S. Food and Drug Administration}}}}</ref><ref name=WHO4 /><ref name=ICH7 />

* Not handwritten (except for handwritten entries thereon)<ref name=EUGMP4 />{{Rp|___location=¶4.6}}

* When electronically produced, the documentation must be checked for accuracy<ref name=EUGMP4 />{{Page needed|date=October 2022|reason=Cannot find this in the document; needs additional reviewer to confirm.}}

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* Critical entries must be independently checked (SPV, or second person verified)<ref name=EUGMP4 />{{Page needed|date=October 2022|reason=Cannot find this in the document; needs additional reviewer to confirm.}}<ref name=FDAJ />

* No spaces for handwritten entries are left blank – if unused, they are crossed out or "N/A" (or similar text) entered

* [[Ditto mark]]s or continuation lines are not acceptable<ref name=FDAnotes>[https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Manufacturing/UCM193421.pdf US FDA. "HUMAN DRUG CGMP NOTES" (Volume 8, Number 3) September, 2000]{{dead link|date=May 2025|bot=medic}}{{cbignore|bot=medic}}</ref>

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

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

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* Regularly reviewed and kept current<ref name=EUGMP4 />{{Rp|___location=¶4.5}}<ref name=EC94 />

* Retained and available for appropriate duration<ref name=EUGMP4 />{{Rp|___location=¶4.12}}<ref name=EC94 /><ref name=EUGMP6 /><ref name=FDAJ>{{Cite web|title=Code of Federal Regulations Title 21|url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211&showFR=1&subpartNode=21:4.0.1.1.11.10

|archive-url=https://web.archive.org/web/20091010065231/http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211&showFR=1&subpartNode=21:4.0.1.1.11.10

|url-status=dead

|archive-date=10 October 2009

| volume= 4 | id = 21CFR211 Subpart J

|access-date=2023-03-07|publisher= U.S. Food and Drug Administration}}</ref><ref name=MHLW169 />

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== GDocP interpretation ==

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

* Prohibition against removing pages<ref name=GDP-TOC>{{citation|last=Hurd |first=Don |others=et al. |title=Good Documentation Practices |date=2010 |pages=11, 17, 30, 39 |publisher=Premier Validation |url=http://www.askaboutvalidation.com/wp-content/uploads/2012/07/51371-contents.pdf |url-status=liveusurped |archive-url=https://web.archive.org/web/20121113215747/http://www.askaboutvalidation.com/wp-content/uploads/2012/07/51371-contents.pdf |archive-date=13 November 2012 |isbn=978-1-908084-00-2 }}<!-- For the original url etc, see oldid=626360228 --></ref> – the removal of a page would obscure the data that were present, so this is not permissible.

* Page numbering<ref name=GDP-TOC /> – the addition of page numbers, particularly in "Page x of y" format, allows a reviewer to ensure that there are no missing pages.

* [[Seal (East Asia)|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.

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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).

Departures from GDocP that involved the regulator have included: documentation not contemporaneous,<ref>[https://web.archive.org/web/20111223061001/http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm271708.htm US FDA. "Warning Letter" UCM271708. Observation #1] – Accessed 27 June 2013</ref><ref>[https://web.archive.org/web/20090806152611/http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM172108.pdf Caraco Pharmaceutical Laboratories, Ltd. Response to the FDA's May 12, 2009, 483. Observation #14a] – Accessed 1 June 2011</ref> use of [[ditto mark]]s,<ref>[https://web.archive.org/web/20090712112312/http://www.fda.gov/downloads/ICECI/EnforcementActions/WarningLetters/1999/UCM067076.pdf US FDA. "Warning Letter" FLA-99-29]</ref> signature stamps.,<ref>[https://web.archive.org/web/20090710053141/http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2006/ucm075960.htm US FDA. "Warning Letter" UCM075960] – Accessed 4 February 2010</ref><ref>[https://web.archive.org/web/20090712084315/http://www.fda.gov/downloads/ICECI/EnforcementActions/WarningLetters/1997/UCM066113.pdf US FDA. "Warning Letter" UCM066113]</ref> obscured original data,<ref name=SOL>[https://web.archive.org/web/20090712085504/http://www.fda.gov/downloads/ICECI/EnforcementActions/WarningLetters/2000/UCM069041.pdf US FDA. "Warning Letter" UCM069041]</ref> Use of pencil,<ref name=SOL /> inaccurate records,<ref name=SOL /> and not dating changes.<ref>[https://web.archive.org/web/20121017205413/http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM214731.pdf US FDA. Form FDA 483 issued to L. Perrigo Co., dated 11/07/2008. Observation #9A]</ref>

== See also ==