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{{Short description|Document standards in pharmaceutical and medical device industry}}
{{Use dmy dates|date=April 2017}}
'''Good documentation practice''' (
In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers.
==
=== Documentation creation ===
* Contemporaneous with the event they describe<ref name=EUGMP4 />{{Rp|___location=¶4.8}}<ref name="FDAGCP">
* 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.}}
* Free from errors<ref name=FDAGCP /><ref name=EC94>[http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf European Commission Directive 2003/94/EC. (Article 9)]</ref>
* For some types of data, it is recommended that records are in a format that permits trend evaluation<ref name=EUGMP6>{{citation |chapter-url=https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-4/chapter4_01-2011_en.pdf |chapter-format=pdf <!-- |work=EudraLex --> |title=The rules governing medicinal products in the European Union |volume=4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use. |chapter=Part I, Chapter 6 Quality Control |date=1 June 2006 |page=3}}</ref>
=== Document approval ===
* Approved, signed, and dated by appropriate authorized personnel <ref name="EUGMP4">
=== Handwritten entries ===
* Adequate space is provided for expected handwritten entries<ref name=EUGMP4 />{{Rp|___location=¶4.6}}<ref name=WHO4 />
* Handwritten entries are in [[indelible ink]]<ref name=EUGMP4 />{{Rp|___location=¶4.6}}<ref name=WHO4 /><ref name=ICH7 />
* 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 />{{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
=== Copies of documents ===
* Clear, legible<ref name=EUGMP4 />{{Page needed|date=October 2022|reason=Cannot find this in the document; needs additional reviewer to confirm.}}<ref name="WHO4">
* Errors are not introduced<ref name=EUGMP4 />{{Rp|___location=¶4.2}}<ref name=WHO4 /><ref name=FDAJ />
=== Document maintenance ===
* 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>
|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 />
* Electronic [[document management system]]s are [[Validation (drug manufacture)|validated]]<ref name=EC94 />
* Electronic records are backed up
=== Document modification ===
* Handwritten modifications are signed and dated<ref name=EUGMP4 />{{Rp|___location=¶4.9}}<ref name=FDAGCP /><ref name=WHO4 /><ref name=ICH7 />
* Altered text is not obscured (e.g., no [[correction fluid]])<ref name=EUGMP4 />{{Rp|___location=¶4.9}}<ref name=FDAGCP /><ref name=WHO4 /><ref name=ICH7 />
* Where appropriate, the reason for alteration must be noted<ref name=EUGMP4 />{{Rp|___location=¶4.9}}<ref name=FDAGCP /><ref name=WHO4 /><ref name=FDAJ />
* Controls exist to prevent the inadvertent use of superseded documents
* Electronic versions can only be modified by authorized personnel
* A history ([[audit trail]]) must be maintained of changes and deletions to electronic versions<ref name=
▲* A history ([[audit trail]]) must be maintained of changes and deletions to electronic versions<ref name=EUGMP4 /><ref name=FDAGCP /><ref name=ICH7>[http://www.ich.org/cache/compo/363-272-1.html#Q7A ICH. "Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients" (Section 6)]</ref><ref name=EC94 />
* 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.)
==
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=
* 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
== See also ==
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