Department | Quality Management | Document no | QMS-020 | ||
Title | Documentation Rule for GMP Documents | ||||
Prepared by: | Date: | Supersedes: | |||
Checked by: | Date: | Date Issued: | |||
Approved by: | Date: | Review Date: | |||
Document Owner
Quality Assurance Manager
Affected Parties
All Colleagues
Purpose
To outline the procedure for the correct way to fill out documents which have a direct bearing on the quality of the product, as required by the Code of Good Manufacturing Practice.
Scope
All Quality documents, and recorded information relating to the batch history of products manufactured at the site.
It is the responsibility of all personnel who make an entry in a GMP document to follow this procedure.
Definition
SOP | Standard Operating Procedure |
Related Documents
Form-400 | Employee Signature Register |
LAB-025 | Laboratory Workbook |
MAN-030 | Production Logbook |
QMS-015 | Quality Documentation Management and Change Control |
QMS-090 | Evaluation of Batch Documentation and Release for Sale |
EHS Statement
There is no EHS impact.
Procedure
Purposes of GMP Documentation
There are many different reasons for the creation and maintenance of GMP documentation. GMP documents are required for one or more of the following reasons:
– Keep track of activities
– Create legal documents
– Provide a historical record
– Provide information
– Comply with regulations.
Nine Characteristics of Quality GMP Record
– Permanent
– Legible
– Accurate
– Prompt (Written at the time activity was done)
– Clear (so anyone can read and understand what it meant)
– Consistent
– Complete
– Direct
– Truthful
Signature Register (Form-400)
A register of all employee signatures and initials is kept in the Signature Register folder located at QA division.
Only the signature or initials used on the Register is permitted to be written on documents.
Signatures
Operators must not sign or initial a document unless they have been trained in the task associated with the signature and in the significance of this signature.
Your signature on a document represents that the task has been performed in accordance with the documented requirements and any deviations have been recorded.
Your signature on a documented must be entered immediately after completion of the task.
If you are signing or initialling a document on behalf of another person, the identity of this person must be entered and you must have authority to do this, (via Delegation of Authority).
Entry of Data and Information
No part of a document that requires information or data to be entered is to be left blank.
If no data entry is required, then “N/A” must be written in the space provided.
Hand written entries must only be made with permanent Blue or Black ink (ballpoint pens). Felt or other water-based pens must not be used due to their tendency to smudge and “run”.
Pencil is not permitted. Red pen is limited to recording of information by the Quality Assurance Officer and only on the ‘Batch Documentation Checklists’.
Hand written data and additional information must be clearly legible. No overwriting is permitted. Corrections to errors must only be made in the manner described in the Section “Corrections” of this SOP.
The recording of information on scrap pieces of paper is not permitted. All recorded information relevant the batch history of a product must only be made on controlled documents, logbooks or workbooks.
Documents including Logbooks and Work Books that require data or any other information to be entered manually must be designed in a way that allows:
– Sufficient space for the entry
– Adequate spacing between entries, and
– For a clear indication of what is to be entered.
Where any headings, items or spaces on a document cease to be used, it should be removed as soon as possible. See SOP QMS-015, for initiating a change to a Quality document.
– Be consistent with date and time.
– Be current. Never use deleted or obsolete document.
Corrections
Any corrections made to a document must be initialled or signed and dated by the person making the change. The correction must permit the reading of the original information. Only a single line through the middle of the original, incorrect entry should be made. If an entry error is made, no explanation for the correction is required. If the error was made for any other reason, a detailed reason for the error and correction must be recorded.
The use of correction fluid or “Liquid Paper” must not be used for correcting errors or for any other reason. The use of erasers is also prohibited.
[Example of CORRECT way to correct errors]
[Example of INCORRECT way to correct errors]
Summary of Changes
Version # | Revision History |
QMS-020 | New |