Plot No. Z104-106, Dahej SEZ II, Tal: Vagra, Dist. Bharuch. Gujarat

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OOS indicates quality issues with the product itself, when analytical results observe out of specification against an established specification limit., while OOL highlights a process control or monitoring concern, when any limits are observed out of limit against established limits.

Hi, you can reach out at [email protected].

cdn.who.int/media/docs/default-source/biologicals/gmp/annex-2-who-good-manufacturing-practices-for-biological-products.pdf?sfvrsn=995d5518_2&download=true#:~:text=URL%3A%20https%3A%2F%2Fcdn.who.int%2Fmedia%2Fdocs%2Fdefault www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice www.fda.gov/vaccines-blood-biologics/biologics-guidances/vaccine-and-related-biological-product-guidances

During Qualification and Validation approach few organizations used Discrepancy term and few used Deviation term but more or less this is the same. Organisation used short kind of form or some automated tools to generate the discrepancy observed during the validation. Discrepancies during CSV should be documented, analyzed, and resolved promptly. Implement corrective actions, update relevant documentation, and conduct a re-validation. Will make on video soon.

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Thats great you are having the experience in AIQ and I believe your practical experience and logic thinking, critical thinking, risk based thinking are required for CSV. Process knowledge and guidelines knowledge are very important to define the validation approach. I would recommend that you must have hands on experience for any system.

Yes, you are right. 21 CFR Part 11 is a regulation, since it is part of the CFR issued by the FDA. Thank you so much for the correction. Everyone please consider this, and I apologise.

There are several ways to act on such situation based on the Quality head approval, few examples are below: 1. Assign the IPQA/Lab QA person to record the data along with operator and there should be the justification for such situation. 2. Some approved paper-based logs or annexure can be used to quickly enter the data and later can transcribed into data sheet/BMR etc. 3. If automated system is there then voicing recognition software can use to interface the data into the original software. And many more...

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When changing the supplier for an excipient, it should be managed through a change control process. Generally, it should be initiated by the QA and evaluate for potential risks and impacts on product quality and compliance.

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Bhai freshers jaa sakte hai?

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Thanks for the suggestion.

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In the pharmaceutical industry, we must follow rules made by government agencies like the FDA or EMA. These rules make sure that medicines are safe, work well, and are good quality. Following these rules is called regulated activity.

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