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 industry 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.
Contemporaneous with the event they describe
Not handwritten (except for handwritten entries thereon)
When electronically produced, the documentation must be checked for accuracy
Free from errors
For some types of data, it is recommended that records are in a format that permits trend evaluation
Approved, signed, and dated by appropriate authorized personnel
Handwritten entries
Adequate space is provided for expected handwritten entries
Handwritten entries are in indelible ink
Errors (i.e. misspelling, illegible entries, etc.) are corrected and reason is documented
Critical entries must be independently checked (SPV, or second person verified)
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
A stamp in lieu of a handwritten signature is not acceptable
Clear, legible
Errors are not introduced
Document maintenance
Regularly reviewed and kept current
Retained and available for appropriate duration
Electronic document management systems are validated
Electronic records are backed up
Handwritten modifications are signed and dated
Altered text is not obscured (e.g., no correction fluid)
Where appropriate, the reason for alteration must be noted
Controls exist to prevent the inadvertent use of superseded documents
Electronic versions can only be modified by authorized personnel
Access to electronic versions must be controlled by password or other means
A history (audit trail) must be maintained of changes and deletions to electronic versions
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 - 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). Here are some examples where such enforcement has occurred that included departures from GDP:
US FDA Warning Letter 320-11-20 (UCM271708) to Yag-Mag Labs Private Limited (Hyderabad, India), Sep 12, 2011
US FDA Warning Letter UCM172108 to Caraco Pharmaceutical Laboratories, Ltd. (Caraco), May 12, 2009
US FDA Warning Letter UCM076496 to Kunshan Chemical and Pharmaceutical Co., Ltd. (Kunshan City, Jiangsu, China), Sep 06 2007
US FDA Warning Letter UCM075472 to Litron Laboratories, Ltd. (Rochester, NY), Jul 01, 2005
US FDA Warning Letter FLA-99-29 to All Medicare Home Aids, Inc., January 28, 1999.
US FDA Warning Letter UCM075960 to Scott A. Spiro, MD, 28-Jun-06.
US FDA Warning Letter UCM066113 to Medtronic, Inc., DEC 2 1997
US FDA Warning Letter UCM069041 to SOL Pharmaceuticals Limited, NOV 21, 2000
US FDA Warning Letter UCM076246 to Gynetics Medical Products NV, JAN 16 2007
US FDA Warning Letter 320-01-02 to SOL Pharmaceuticals Limited, NOV 21, 2000
US FDA Warning Letter UCM221006 to Haw Par Healthcare Limited (Singapore), July 20, 2010
US FDA Warning Letter 320-01-02 to SOL Pharmaceuticals Limited, NOV 21, 2000
Hand changes not dated
Form FDA 483 issued to L. Perrigo Co., NOV 7, 2008.
