Good Documentation Practice (GDP) is a term in the pharmaceutical industry to describe standards by which document

Document

The term document has multiple meanings in ordinary language and in scholarship. WordNet 3.1. lists four meanings :* document, written document, papers...

s are created and maintained. While some GDP standards are codified by various competent authorities

Competent authority

A competent authority is any person or organization that has the legally delegated or invested authority, capacity, or power to perform a designated function....

, others are not but are considered cGMP

Good Manufacturing Practice

"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...

 (with emphasis on the "c", or "current"). Some competent authorities release or adopt guidelines, and they may include non-codified GDP 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.

Documentation creation

• 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, the documentation must be in a format that permits trend evaluation

Handwritten entries

• Adequate space is provided for expected handwritten entries
• Handwritten entries are in indelible ink
• 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 mark
  Ditto mark
  The ditto mark is a typographic symbol indicating that the word or figure above it are to be repeated. For example:It has Unicode code-point U+3003 , though in practice closing double quotation marks or straight double quotation marks are often used instead...
  
  s or continuation lines are not acceptable
• A stamp in lieu of a handwritten signature is not acceptable

Document maintenance

• Regularly reviewed and kept current
• Retained and available for appropriate duration
• Electronic document management system
  Document management system
  A document management system is a computer system used to track and store electronic documents and/or images of paper documents. It is usually also capable of keeping track of the different versions created by different users . The term has some overlap with the concepts of content management...
  
  s are validated
  Validation (drug manufacture)
  Validation in the pharmaceutical, medical device, food, blood establishments, tissue establishments, and clinical trials industries is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the...
  
  
• Electronic records are backed up

Document modification

• Handwritten modifications are signed and dated
• Altered text is not obscured (e.g., no Wite-Out
  Wite-Out
  Wite-Out is a trademark for a line of correction fluid, originally created for use with photocopies, and manufactured by the BIC Corporation.-History:...
  
  )
• Where appropriate, the reason for alteration must be noted ("E.E." is a common abbreviated reason, indicating "Entry Error")
• 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
  Audit trail
  Audit trail is a sequence of steps supported by proof documenting the real processing of a transaction flow through an organization, a process or a system.....
  
  ) must be maintained of changes and deletions to electronic versions

GDP Interpretation

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 GDP 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 an transcription and the original retained nevertheless.
• Scrap paper, Post-it note
  Post-it note
  A Post-it note is a piece of stationery with a re-adherable strip of adhesive on the back, designed for temporarily attaching notes to documents and other surfaces. Although now available in a wide range of colours, shapes, and sizes, Post-it notes are most commonly a square, canary yellow in colour...
  
  s - 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
  Asterisk
  An asterisk is a typographical symbol or glyph. It is so called because it resembles a conventional image of a star. Computer scientists and mathematicians often pronounce it as star...
  
   (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.

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). Here are some examples where such enforcement has occurred that included departures from GDP:

Documentation not contemporaneous

• US FDA Warning Letter
  FDA Warning Letter
  The United States Food and Drug Adminstration defines a Warning Letter as "...a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations...
  
   UCM172108 to Caraco Pharmaceutical Laboratories, Ltd. (Caraco), May 12, 2009

Use of ditto marks

• US FDA Warning Letter FLA-99-29 to All Medicare Home Aids, Inc., January 28, 1999.
• US FDA Warning Letter 2008-DAL-WL-19 to Simmons Pet Food, Inc., July 23, 2008

Use of signature stamp

• US FDA Warning Letter UCM075960 to Scott A. Spiro, MD, 28-Jun-06.
• US FDA Warning Letter UCM066113 to Medtronic
  Medtronic
  Medtronic, Inc. , based in suburban Minneapolis, Minnesota, is the world's largest medical technology company and is a Fortune 500 company.- History :...
  
  , Inc., DEC 2 1997.

Obscured original data

• US FDA Warning Letter 320-01-02 to SOL Pharmaceuticals Limited, NOV 21, 2000
• US FDA Warning Letter UCM076246 to Gynetics Medical Products NV, JAN 16 2007

Inaccurate records

• US FDA Warning Letter 320-01-02 to SOL Pharmaceuticals Limited, NOV 21, 2000