Audit your facility with respect to the following observations and fill the gaps as per the procedure if any:
OBSERVATION 1
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Description:
SOPs are not written properly.
Written SOPs are not followed.
OBSERVATION 2
Laboratory records do not include complete data derived from all tests, examinations, and assays necessary to assure compliance with established specifications and standards.
Description:
Documentation is incomplete.
All the tests and examinations are not recorded in the books/records.
Online documentation is not there.
No review system.
No control of compliance and quality.
OBSERVATION 3
Batch production and control records do not include complete information relating to the production and control of each batch.
Description:
Batch production and control records are not completed online.
In complete batch records.
OBSERVATION 4
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Description:
The Aseptic Process is not validated.
No validation system compliance.
OBSERVATION 5
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Description:
Out-of-specification, discrepancy, and product failure were not investigated properly.
Investigation, deviation procedure compliance not in place.
OBSERVATION 6
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Description:
Lack of adequate written procedures/SOPs/ system for production and process controls.
OBSERVATION 7
Appropriate controls are not exercised over computers or related systems to ensure that changes in master production and control records or other records are instituted only by authorized personnel.
Description:
21 CFR part 11 compliance is not there.
OBSERVATION 8
Changes to written procedures are not drafted, reviewed, and approved by the appropriate organizational unit.
Description:
Changes are done without change control procedure.
OBSERVATION 9
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Description:
Analytical methods are not validated.