Tuesday, 17 July 2018

GDP(Good Documentation Practices)

Good Documentation Practices are the soul of many regulated industries. The FDA, like all other regulatory agencies, makes GDP a central element of its regulations, and bases it on the principle of evidence. For the FDA and other regulatory agencies across the world, what is not documented is nonexistent.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 and medical device industries to describe standards by which documents are created and maintained.

What to write, and how to
GDP should not only be about just writing down; it is about what to write and also, how, meaning, in what manner. If there has been an intervention in any method of manufacture or any other activity in the regulated industries; the change should be noted down in the proper format as prescribed by the FDA. This enables everyone concerned, from the people in the organization to the auditors to the regulatory agencies, to clearly identify what action was carried out, by whom and when. This further leads to a discovery of the impact of the actions. This is the key to determining the effectiveness of the application of the GDP principles in the particular case.

GDP / GDocP standards

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, it is recommended that records are in a format that permits trend evaluation

Document approval

  • 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

Copies of documents

  • 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

Document modification

  • 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.)

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