Tag: sterilizer

Where should airflow velocity measurements be taken, with respect to a filling line or other aseptic processing areas?

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| Validation

  Recommendation Airflow velocity measurements should be taken at locations where meaningful and reproducible results can be obtained. This typically at a distance of 15-30 cm from the filter face. Rationale for Recommendation The primary reason for airflow velocity measurements in unidirectional airflow areas (e.g, area where products , product contact packaging components, and product contact surfaces are exposed) is to ensure adequate airflow to protect […]

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Application of near infrared spectroscopy to the analysis and fast quality assessment

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| fnd and production

NIRS combined with appropriate mathematical models and pattern recognition techniques allows analysis of a wide variety of sample types rapidly. Second, NIRS is a non-destructive technique which avoids complex sample preparation by chemical or physical processes. In fact, both solid and liquid samples in different types of packaging stored under different conditions can all be […]

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When the FDA Inspector visits your firm, What are the Chances of a Really Bad Outcome?

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| Drug regulatory and guidelines

It’s generally nerve-wracking when the US Food and Drug Administration (FDA) shows up at your door for an inspection. Even if you’re confident that everything is in good shape around every corner. To ensure compliance with regulations, the FDA conducts inspections of all registered establishments.  Once the inspection is closed out, it is categorized in […]

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

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| Uncategorized

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 packing material. 2. Why compressed air and recirculated water used for washing? Compressed air used […]

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HVAC Control and Monitoring System Validation

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| Air Handling System

The control and monitoring systems are considered the core of the environmental control system. The final performance of the environmental control system can be evaluated only after these have been validated. PQ protocols covering this system, in general, include the performance challenges for the all the components of the environmental control system described in the […]

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Major USFDA warning Letters observation from 2000

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| Drug regulatory and guidelines, News Updates

The United States Food and Drug Administration (FDA) defines a Warning Letter as “…a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be […]

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Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 7)

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| Interview & Placement

GMP Question and Answers Why is GMP important?Poor quality medicines are not only a health hazard, but a waste of MONEYfor both governments and individual consumers. Poor quality medicines can damage health?A poor quality medicine may contain toxic substances that have been unintentionally added.A medicine that contains little or none of the claimed ingredient will […]

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Define re-test period of API and Excipients

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| Uncategorized

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. API: Active Pharmaceutical IngredientFPP: Finished Pharmaceutical Products Stability – purpose: a) To establish a re-test […]

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