Good documentation practice: Difference between revisions

Revision as of 13:44, 19 June 2021

Revision as of 17:36, 13 July 2021

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== GDP / GDocP standards ==

=== Documentation creation ===

* Contemporaneous with the event they describe<ref name=EUGMP4 /><ref name=FDAGCP>[https://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm135196.htm US FDA. "Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS" April 1999] -– Accessed 4 February 2010</ref><ref name=WHO4 /><ref name=ICH7 />

* Not handwritten (except for handwritten entries thereon)<ref name=EUGMP4 />

* When electronically produced, the documentation must be checked for accuracy<ref name=EUGMP4 />

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* Errors (i.e. misspelling, illegible entries, etc.) are corrected and reason is documented

* Critical entries must be independently checked (SPV, or second person verified)<ref name=EUGMP4 /><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]</ref>

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

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=== Copies of documents ===

* Clear, legible<ref name=EUGMP4 /><ref name=WHO4>[http://whqlibdoc.who.int/trs/WHO_TRS_961_eng.pdf#page=106 WHO. TRS 961 "Good Manufacturing Practices for Pharmaceutical Products: Main Principles" 2011 (Annex 3, Section 15)]</ref><ref name=MHLW169>[http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf 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)] {{Webarchive|url=https://web.archive.org/web/20110722105510/http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf |date=22 July 2011 }} -– Accessed 7 January 2011</ref>

* Errors are not introduced<ref name=EUGMP4 /><ref name=WHO4 /><ref name=FDAJ />

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* 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 Interpretationinterpretation ==

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=live |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> -– Thethe 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.

* [[Calendar date#Date format|Date and time formats]]<ref name=GDP-TOC /> -– 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<ref name=GDP-TOC /> -– Aa 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 note]]s -– Intentionallyintentionally 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 -– Wherewhere 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.<ref name=GDP-TOC /> 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).

Departures from GDP that involved the regulator have included: documentation not contemporaneous,<ref>[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm271708.htm US FDA. "Warning Letter" UCM271708. Observation #1] -– Accessed 27 June 2013</ref><ref>[https://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://www.fda.gov/downloads/ICECI/EnforcementActions/WarningLetters/1999/UCM067076.pdf US FDA. "Warning Letter" FLA-99-29]</ref> signature stamps.<ref>[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2006/ucm075960.htm US FDA. "Warning Letter" UCM075960] -– Accessed 4 February 2010</ref><ref>[https://www.fda.gov/downloads/ICECI/EnforcementActions/WarningLetters/1997/UCM066113.pdf US FDA. "Warning Letter" UCM066113]</ref>, obscured original data,<ref name=SOL>[https://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://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 ==