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New Discussion

Can we use an API after expiry date of that on the provided COA or is there any way to use it by getting retested. What is the reference for this?

QUALITY MANAGEMENT SYSTEM

04-02-2018


Agreed with Himanshu as per Schedule M if any API have shorter expiry then product shelf life then product shelf life should not be more than API shelf life. In that case short expiry of API to be assign to product. If supplier only provide expiry of any raw material then we can not re-test and use in product however if he declare that retest period of raw material then you can retest and use.

What is objectionable microorganism and their significance in pharmaceutical industry..

Pharmaceutical Microbiology

01-02-2018


Hi All,

Its a very interesting topic and I can discuss and learn on this topic for the whole day. some of our notorious micro visitor in the pharmaceutical facility has always been a big concern. since the day of 1970 when a gram-negative bacteria was highlighted for creating serious health hazard as a contaminant present in a topical preparation to till date, all these nuisance creators are called as objectional microorganisms. when we talk about objectional microorganisms our mind restricts ourself for only those microorganisms which are listed in respective monographs, and it's true that beyond this if you got any microorganism you opt for releasing the batch. the problem is not that you released the batch, the problem is still pharma company gives a second thought to non-sterile drug products as compared to sterile preparations. But there is no objectional kind of microorganism in sterile preparations, contamination means contamination for sterile and batch should be restricted for sale to market. one of the other problems is also that still people either don't investigate the source or lazy in microorganism identification (especially dosage form other than sterile preparations) or they don't have identification method for identification of identified microorganisms from the product. For example, Pseudomonas cepacia contamination in Povidone-Iodine was one of the problems reported of major health hazard and there is no testing method for identification of this microorganism in pharmacopeia. 

It is the need of the hour that microbiologist across the world in pharmaceutical industry should differentiate between specified indicator organism listed in  pharmacopeia and understand that monograph cannot cover all objectional microorganism. Its site's responsibility to identify the source based on their geographies and environmental factors to investigate, isolate and perform identification of pathogenic microorganisms up to species level. There should be adequate method to control the observed pathogenic microorganism from the facility, and selection of media to support identified microorganism. Further, it should not be restricted to bacteria, yeast and molds should also be considered which most of the time they are neglected or ignored or not reported when identified. there were several problems reported for yeast and mold contamination in formulated drugs for rectal, urethral and vaginal applications. 

Even the health regulators are more concerned about these objectional microorganisms and approach of pharmaceutical industry to handle that. you will be surprised that USP in chapter 61 they are removing the retest provision. Now if you get any contamination it should be reviewed and investigated that the contamincaiton is not evenly distributed across the lot/batch. and unless and until justified site should not consider retesting of the samples. 

I hope you enjoyed reading...have a lot of stuff to discuss...but I appreciate your feedback and please come back if you need further information. 

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