Let me first give my view on the observation noticed and I’ll explain why I feel the quality is outdated.
Observation 1: it says that the product would fail for with respect to the content of impurity if the product during production is stored at particular temperature for more than a particular time during production. A company manufacturing a product for a highly regulated market should be aware at what temperature the product, whether drug or intermediate is stable and for how may hours.
Observation 2: they have a contradiction in the self life and release specification. (Self life: how long the product is stable and fit for use both in respect to content of drug and impurity; specification: the condition based on which the batch of drug is released). It seems the specification for release of a drug is less than the self life of the drug. Also the impurity content is not mentioned in the release parameters for certain drug. (Content of impurities should be less than a particular value for drugs: plays a major role in safety).
Observation 3: cleaning plays a vital role in the manufacturing of drugs, particularly potent and cytotoxic drugs. The observation mentions either the cleaning is not properly performed or its not properly documented. Documentation is a very basic element, not only in pharma but also in any basic science.
Observation 4: it talks about REPETITIVE complaints and the failure to identify its root cause. So the mistake will occur in the future too. They have not considered the out of specification results. Again something very basic. If we get a mistake, all we have to ask is: why it occurs and what I have to do to avoid it.
Observation 5: it talks about the lacuna in sterile operations, right from the unwanted persons during media fill, to the maintenance of sterile conditions during filling. Sterility of injection is very important particularly in immunocompromised patients.
Observation 6: the stability studies were not performed correctly to monitor all the impurities. (Observation 1 may be the result of this).
Observation 7: it talks about the the permission given to the analyst to change the criteria for the quantification of impurities. E.g. the system will not detect the impurity below a certain quantity, certain time etc. (related to observation 1 and 6),
Observation 8: it mentions that the testing and release criteria of the final product is not reliable.
Observation 9: it says that the sample size is not statistically acceptable.
Observation 10: the training for visual inspectors is not adequate.
The Pharma production is moving towards parametric release i.e. the quality of the drug will not fail so that the final testing is not necessary (because each and every stage of the production is controlled) - The exact meaning for quality assurance (quality is assured).
These 10 observations mentions that they are still struggling with the very basic elements of recording the data itself. Also they are not concentrating on impurities (during stability study itself), cleaning (may be they have cleaned, but only record speaks), investigation of complaints (oos), etc. - all these are very elemental.
On the brighter side there were no data integrity issues. So they can correct the issues through CAPA and revamp their quality mindset - it would be better for the company in the long run.
Disc: not invested.
