good documentation practice

• Contemporaneous with the event they describe{{Rp|location=¶4.8}}{{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=dead |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}}}}
• Not handwritten (except for handwritten entries thereon){{Rp|location=¶4.6}}
• When electronically produced, the documentation must be checked for accuracy{{Page needed|date=October 2022|reason=Cannot find this in the document; needs additional reviewer to confirm.}}
• Free from errors[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)]
• For some types of data, it is recommended that records are in a format that permits trend evaluation{{citation |chapter-url=https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-4/chapter4_01-2011_en.pdf |chapter-format=pdf |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}}

• Approved, signed, and dated by appropriate authorized personnel {{Cite report |chapter-url=https://health.ec.europa.eu/system/files/2016-11/chapter4_01-2011_en_0.pdf |title=Volume 4. Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use |date=2010 |access-date=15 October 2022 |url-status=live |archive-url=https://web.archive.org/web/20220719030317/https://health.ec.europa.eu/system/files/2016-11/chapter4_01-2011_en_0.pdf |archive-date=19 July 2022 |chapter=Chapter 4. Documentation |publisher=European Commission, Health and Consumer Directorate-General |location=Brussels }}{{Rp|location=¶4.3}}

• Adequate space is provided for expected handwritten entries{{Rp|location=¶4.6}}
• Handwritten entries are in indelible ink{{Rp|location=¶4.6}}
• Errors (i.e. misspelling, illegible entries, etc.) are corrected and reason is documented
• Critical entries must be independently checked (SPV, or second person verified){{Page needed|date=October 2022|reason=Cannot find this in the document; needs additional reviewer to confirm.}}
• 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[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}}
• Correction fluid are not allowed to be used in correcting errors
• A stamp in lieu of a handwritten signature is not acceptable

• Clear, legible{{Page needed|date=October 2022|reason=Cannot find this in the document; needs additional reviewer to confirm.}}{{Cite tech report |url=https://apps.who.int/iris/bitstream/handle/10665/44079/WHO_TRS_961_eng.pdf |chapter-url=https://apps.who.int/iris/bitstream/handle/10665/44079/WHO_TRS_961_eng.pdf#page=106 |last=WHO Expert Committee on Specifications for Pharmaceutical Preparations |title=Forty-fifth Report |number=961 |institution=World Health Organization |date=2011 |series=WHO Technical Report Series |chapter=Annex 3. WHO good manufacturing practices for pharmaceutical products: main principles |url-status=live |archive-url=https://web.archive.org/web/20220901051256/https://apps.who.int/iris/bitstream/handle/10665/44079/WHO_TRS_961_eng.pdf |archive-date=1 September 2022 }}[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
• Errors are not introduced{{Rp|location=¶4.2}}

• Regularly reviewed and kept current{{Rp|location=¶4.5}}
• Retained and available for appropriate duration{{Rp|location=¶4.12}}{{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}}

• Electronic document management systems are validated
• Electronic records are backed up

• Handwritten modifications are signed and dated{{Rp|location=¶4.9}}
• Altered text is not obscured (e.g., no correction fluid){{Rp|location=¶4.9}}
• Where appropriate, the reason for alteration must be noted{{Rp|location=¶4.9}}
• 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{{Cite web|title=ICH Official web site : ICH|url=https://www.ich.org/index.html|access-date=2023-03-07|website=www.ich.org}}
• 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{{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=usurped |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 }} – the removal of a page would obscure the data that were present, so this is not permissible.
• Page numbering – 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 – 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 – 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. 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.

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,[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[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 use of ditto marks,[https://web.archive.org/web/20090712112312/http://www.fda.gov/downloads/ICECI/EnforcementActions/WarningLetters/1999/UCM067076.pdf US FDA. "Warning Letter" FLA-99-29] signature stamps.,[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[https://web.archive.org/web/20090712084315/http://www.fda.gov/downloads/ICECI/EnforcementActions/WarningLetters/1997/UCM066113.pdf US FDA. "Warning Letter" UCM066113] obscured original data,[https://web.archive.org/web/20090712085504/http://www.fda.gov/downloads/ICECI/EnforcementActions/WarningLetters/2000/UCM069041.pdf US FDA. "Warning Letter" UCM069041] Use of pencil, inaccurate records, and not dating changes.[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]

• Best practice
• Good manufacturing practice
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