QAS-018 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 329

SOP No. QAS-018.00 Effective date: mm/dd/yyyy
Approved by:

Level 3: Quality-related reporting formats stated or not stated in the SOP, but permanently
used. The format should be signed by the supervisor and if additional formats are used,
mention the reason with signature of the supervisor for additional format.

Level 4: Quality-related reporting formats under trial may or may not be the part of
SOP.

document security check

Level 1 Distribution to be documented and controlled

Level 2 Distribution to be documented and controlled

Level 3 Formats can be photocopied by individual departments for reporting

Level 4 Formats can be photocopied by individual departments for reporting

2. The documents are stored in relevant departments as appropriate.
3. The superseded documents are withdrawn.
4. The changes are incorporated in the documents in the reasons for revision and approved.
The following documents identified to have reasons for revision are:
a. Finished product specification
b. Raw material specification
c. Packaging material specification
d. Master packaging instruction
e. SOPs
f. STMs
g. Stability report
5. For MFM a separate register is maintained for all the changes carried out.
6. The development documents are reviewed according to the written SOP.
7. The files are well maintained and segregated.
8. The responsibilities for the writing, issue, and holding of documents are clearly defined.
9. The indices are maintained to indicate the current status of the documents.
10. The registers are maintained to indicate distribution of records.
11. The documents received from the external organizations are recorded on registers.
12. The technical documents and SOPs produced are formally drafted, reviewed, approved,
and authorized for distribution.

13. The documents are issued formally describing their purpose and responsibility as
applicable.

14. The documents are reviewed as and when necessary to ensure recipients receive updated
copies.

15. All departmental managers are allowed to make one set of photocopy of the document in
use to incorporate changes and send it to the QA and R&D department for relevant changes.
The changes should be documented in the reasons for revision column.

16. The level 3 and 4 documents can be copied for regular use.

37.4 good documentation guideline

1. SOPs and the technical documents are to be signed with a blue pen.

2. Overwriting is not allowed in SOPs and other technical documents.

3. As a part of a good documentation skill, if a wrong entry is made, delete the previous entry
in a way that it should be visible. Make a new entry beside, below, or above and sign.