On what ground a Drug is Rejected during Quality Check

The pharmaceutical quality control laboratory is a crucial step in pharmaceutical production and control. A set CGMP regulation is set for quality control lab and product testing. Drug Quality control check aims to check the specific methodology used in manufacturing, assessment of laboratory’s conformance with GMP’s, and the aspects of laboratory operations.

Quality assurance in Pharmaceutical industry

The inspection of the drug quality by CGMP combines the inspection of the observation of the laboratory and the law laboratory data to evaluate the compliance. The lab reports and records are a source of information for evaluation. Additionally, raw laboratory data, laboratory procedures, equipment’s, techniques, calibration, and method validation data are other resources of information that should comply with the cGMP guidelines. The pharmaceutical supply chain is also reviewed for the same.

The inspections determine the data submitted with the application is authentic or not. It keeps a close check on the manufacturing process to related the data presented with the actual data. The analytical report submitted by the manufacturer contains only the test results and matters. The analysis report tells why the drug is safe and effective for approval. But, the end decision is of the inspection team.

The team looks for a valid scientific justification for its decision. If the report is in compliance with the CGMP guidelines, the product is approved and accepted. In the case of non-compliance or the inability of the product to meet the predetermined specifications, the product is rejected. A complete report of rejection is provided stating the grounds of rejection.

Reason for Drug rejection during quality check

A drug is rejected on multiple factors. Type of laboratory test failures suggests whether a product may be rejected or may be sent again for retesting and resampling. FDA identifies the product failure as out of specification lab results. The out of specification result tells about the factors that have led to failure. It may be a laboratory error, a non-process related or operator error, and a process related or manufacturing process error.

Laboratory errors occur there are mistakes in analysis method, incorrect standards, and miscalculation. The laboratory investigation is done to discuss the testing procedure, the calculation, examination of the instruments, and reviewing the notes of OOS results.

The results of the quality check are provided to the manufacturer stating analytical mistakes, calculation errors, manufacturing method faults, inaccurate process, safety errors etc. A written documentation with conclusion and justification is provided. The failure investigation is submitted within 20 days of the occurrence of problems.

For Retesting and resampling again a laboratory investigation is required. It can be done on the same sample, not a different sample. For retesting the second aliquot is taken from the same portion of the sample for which the first testing was done. Resampling can alone not give approval. As per the guidelines, a successful resample test alone can’t invalidate an initial OOS result. For the test to be validated there should be an evidence that discloses that the original sample was not prepared properly. Thus, FDA approval is a long procedure and once rejected requires a lot of research to find out the cause of rejection.


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