Good Documentation Practices
Good documentation practices (GDP) are a necessity when working within a current good manufacturing practices environment.
This white paper reviews the importance of following GDP when documenting data and information within a cGMP environment.
Table of Contents
- Clearly Written Documentation
- Amending Data
- Indelible Ink
- Reviewing & Approving
- Page Numbering
- Handwritten Documentation
- Common GDP Errors
Let’s dive in.
Overview of Good Documentation Practices
Good documentation practices are a clearly defined method for documenting data and records within a cGMP business environment. GDP should be used on any cGMP document or logbook. Companies should have an SOP or policy that defines all the specific requirements for documenting within that company.
It’s important to use GDP to ensure industry standards are being met.
Good documentation practices to define include:
- Ink color
- EE = Entry Error
- WD = Wrong Date
- NA = Not Applicable
- Date formats
- Types of logbooks / binders / forms that can be used
Clearly Written Documentation
All data entries must be accurately recorded in a manner consistent with the governing procedure or policy in order to prevent errors. Everything should be documented — if it is not written down according to procedure, it will be assumed that it didn’t happen.
Any corrections made to existing data or documentation must be done clearly in accordance with the procedure. When correcting, data should never be covered up or destroyed in the process. A single line through the incorrect data with an explanation, initials and date is how it should be done.
Use Indelible Ink
cGMP records need to be permanent and last indefinitely. Therefore, pencil or erasable ink should not be used. The acceptable color of ink should be defined by the governing procedure — this is typically blue or black ink. This also helps provide consistency throughout the documentation within the business.
Reviewing & Approving
All cGMP documents should be reviewed by a properly trained individual who did not perform the actual task to ensure there are no errors. A signature and date of the reviewer/approver signifies that the data has been reviewed and is complete and accurate.
All cGMP pages or forms should be numbered “Page number X of Y” to indicate total number of pages within the document.
All handwritten entries need to be recorded as neatly as possible so the entry is legible for future reference. All entries must be made at the time the task is performed, initialed and dated. Remember never to sign for other individuals.
Common GDP Errors to Avoid
- Write overs
- Illegible entry
- Ditto marks ” “
- Drawing a line with an arrow down a row of spaces to indicate “the same thing should be written there”
- Complete cover up of or scribble over any data when crossing out. Always use one line cross-outs only.