Category Archives: Pharmaceutical and Biotechnological

Compliance to regulatory requirements in Pharmaceutical industries

Current regulatory inspection is come up with lots of recommendations. In this article will be discussing regarding the different regulatory requirements. This is the time to evaluate our existing procedure and mitigating the risk. Here will discuss about the recommendation … Continue reading

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Recipe control in manufacturing system

Now a day’s regulators looking for control on the product /system recipe. Recipes  are very critical part of process. Because process are control through validated recipe. If firm calming that their system complying 21 CFR par 11/EU annex 11, in … Continue reading

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Design, Operation, Qualification and maintenance of Isolator

Isolators have been around the Pharmaceutical Industry since the early 1980s and in the Nuclear Industry (glovebox technology) since the 1950s. The intent of isolators is to create an airtight barrier or enclosure around a piece of equipment or process … Continue reading

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Media fill FAQ

1. What is the acceptable media fill frequency in relation to the number of shifts? Normally, media fills should be repeated twice per shift per line per year. Is the same frequency expected of a process conducted in an isolator?A … Continue reading

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Use of Nitrogen gas in lyophilizer during media fill

Process simulation studies (media fills) are simulating the whole process in order to evaluate the sterility confidence of the process. Process simulation studies include formulation (compounding), filtration and filling with suitable media. Simulations are made to ensure that the regular … Continue reading

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Regulatory guidace on Smoke study

Air pattern or “smoke” studies demonstrating laminarity and sweeping action over and away from the product under dynamic conditionsshould be conducted.   The studies should be well-documented with written conclusions.  Videotape or other recording mechanisms have been found to be useful … Continue reading

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Label Control

Overview   Controlling the storage and issuing of labels and labeling helps prevent mix-ups. Technology, such as bar-codes and vision systems, has reduced the number of   label – related recalls, but controlling label storage and issuance is still very important. … Continue reading

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Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 8)

Requested By: for KVR SudhirOrganization: PharmaceuticalsCategory : Parenterals Questions A.     VIAL WASHING  MACHINE QUESTIONS 1. What is purpose of vial washing machine? Objective: Cleaning of Vial externally and internally to reduce the bio-burden. Note:  It is used as a primary … Continue reading

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Define re-test period of API and Excipients

Stability – Definition: How the quality of an API or FPP varies with time under factors such as temperature, humidity and light.Studies also show how product-related factors influence stability: the properties of API/excipients, FPP composition, manufacturing process, and container-closure system. … Continue reading

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