Good Documentation Practices is an integrity part of a manufacturer, which if records are written properly with less error makes an auditor/customer impressed.
Why Good Documentation Practices Required?
1. Regulatory requirement and standard industrial practices
2. To maintain accountability
3. To provides an audit trails, this would enables investigation in to history of any defective drugs
All documents shall be signed in full or short signature with indelible blue. All the signatures should be accompanied with date. Use standard familiar English when writing information. Write clearly to avoid misunderstandings.
Data should be recorded correctly and promptly at the time of each action, and on completion of each activity, the records shall be immediately signed and dated by the person carrying out the activity and also counter checked, signed and dated by second authorized person.
Correction of error
An error in entry shall be corrected by cutting with a single horizontal line so that the original (wrong) entry is still visible and writing the correct data after putting initial and date on which the correction is made. Where necessary, reason(s) for correction(s) shall also be recorded, initialed and dated.
Verification of data, information, calculations and tasks
Verification of data, information, calculations or tasks performed by another person means that the verifier has independently determined that the data, information, calculations or tasks are accurate and correct. For e.g. when a calculation is being verified, the verifier will repeat the calculation before signing for it.
Missed information/data and blank spaces in documents
There should be no gaps in information on a document. Always complete all required information and be consistent when documenting units of measure, dates, acronyms, and abbreviations.
If an entry missed on a controlled document (e.g.) Incase where there is a missing data that is retrievable from another document or database then make a copy or printout of the information and write an explanation, initials, and date on it, and attach it to the record.
In case any particular information asked for, is not applicable in certain cases then “NA” shall be written with sign & date in the space provided for the entry means “not applicable”.
In case after making the required entries, if some space is left blank then these space shall be crossed with a single line starting from the left hand side top diagonally to right hand side bottom and it shall be initialed & dated.
DO’s in Good Documentation Practices
All entries shall be done by Blue ballpoint pens only.
Proper units of measurements (o C, Kg & L) are used.
Data shall be recorded in the proper place
Report difficulties in carrying out the instructions to the senior
Suggest improvements in BPR
Report errors and get it corrected.
Record the observation in approved worksheet
Don’ts in Good Documentation Practices
Do not use Pre-inked stamps for signatures or initials on Documents.
Do not use any other ink-color, pencil and “post it tags’’.
Do not erase, scratch out, or cover over once recorded.
Do not use correction fluid, correction tapes.
Do not trace over any written information or data (Overwriting) in an attempt to make it clearer.
Do’s, Ditto’s and curved brackets are not accepted in the documents.
Points to note:
Use of Ditto’s stamps, pencil, inaccurate records and changes without proper justification has been observed by FDA audits and listed in warning letters.
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