21 CFR Part 210-211 Sec. 211.192 Production Record Review Requirements

[medic]

Hello,
I work in Quality Assurance department in a pharmaceutical company. Our main production is solid dosage forms.
According to 21 CFR Part 210-211 Sec. 211.192 "Production record review":
"All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed."

My question: Is there any option to review only critical parameters by quality assurance before releasing the batch? Or we must always review the entire batch record?
Thank you!

[Jennifer Kirley]

Welcome to the Cove!

It would help if we knew what your product is, and what standard you are working to. For example, the automotive standard TS 16949 wants us to control and inspect based on critical parameters, but to also prevent/screen out cosmetic flaws on visible surfaces.

[sagai]

Is it really in Part11?
Cheers!

[v9991]

PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
http://www.accessdata.fda.gov/script...t=211&showFR=1

purpose&scope of the QC/QA-review is outlined in the regulation..

Sec. 211.192 Production record review.
Any unexplained discrepancy (including a percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records) or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed. The investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and followup.

same is reinforced earlier in the

Sec. 211.22 Responsibilities of quality control unit.
(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.

'whatever/whichever procedure is employed by QA/QC for review',
1) Devising a checklist highlighting critical points to guide the review process
2) delegating the review of activities to respective HODs. (viz., QC to sign off the clearance of analytical compliance, production to sign off on yields etc)
3) automating the collation-verification of all activities with appropriate flagging of exceptions

irrespective of the procedure devised/implemented by QA/QC for batch release, final accountability lies with QA/QC.

[Ajit Basrur]

In Reply to Parent Post by medic

Hello,
I work in Quality Assurance department in a pharmaceutical company. Our main production is solid dosage forms.
According to 21 CFR Part 210-211 Sec. 211.192 "Production record review":
"All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed."

My question: Is there any option to review only critical parameters by quality assurance before releasing the batch? Or we must always review the entire batch record?
Thank you!

Batch Release is an important activitiy which includes all aspects of the batch and hence review of just critical parameters by QA is not acceptable.