Monthly Archives: October 2012

Component Of Master Validation Plan

Content may include the following descriptions (but not be limited to): 1. Introduction1.1 Project Description1.2 What a Validation Master Plan Is1.3 Scope of Validation Master Plan1.4 Definition for the Term Validation1.5 Validation Team Member1.6 Validation Team Responsibility 2. Concept of … Continue reading

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Basic Concept Of Validation

1. Definition of Validation   Action of proving, in accordance with the principles of good manufacturing practice, that any procedure, process, equipment, material, activity, or system actually leads to the expected result Documented evidence which provides a high degree of assurance … 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 1)

Interview questions mostly asked during technical round in Production : 01. Q. Which type of tablets are exempted from Disintegration testing? A. Chewable Tablets 02. Q.What are the common variables in the manufacturing of tablets?A.·       Particle size of the drug … Continue reading

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Cleaning Validation And Its Importance In Pharmaceutical Industry

Pharmaceutical manufacturers must validate their cleaning process to ensure compliance with cGMP regulations. Minimizing equipment downtime has the potential to impact the efficiency and economics of pharmaceutical production. The main purpose of cleaning validation is to prove the effectiveness and … Continue reading

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Steam Quality Parameters And Effects Of Their Deviations From Accepted Values

Steam Dryness: The measure of the water content of steam deliverd to the sterilizer chamber.Acceptable values are 0.9 or greater (<10% water) for non-metallic loads and 0.95 or greater (<5% water) for metallic loads. Wet steam can cause an unsterile … Continue reading

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Steam Purity Checks Before Start Sterile Operation In Biopharmaceutical Industries

In the pharmaceutical manufacturing and health-care industries, there are basically two types of steam–process steam and pure steam. Process steam is also known as plant steam, black steam, utility steam, boiler steam etc. Pure steam is sometimes known as clean … Continue reading

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7 steps of Corrective Action Preventive Action (CA-PA)

CAPA (Corrective Action Preventive Action) and failure investigation become more and more important for the pharmaceutical industry. This becomes clear in a series of guidance documents. Above all with the ICH Q10 document, CAPA was introduced as a new quality-assuring … Continue reading

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Quality Assurance(QA) role In Pharma Industry

Technology Transfer : Receipt of product design documents from Research Center. Distribution of documents received from Research Center (RC). Checking & approval of documents generated based on RC documents i.e. Batch Manufacturing Record. Scale-up and validation of product Validation : … Continue reading

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APPLICATION OF THE D,Z AND F0 VALUE CONCEPT TO STEAM STERILISATION

The F0 value of a saturated steam sterilisation process is the lethality expressed in terms of the equivalent time in minutes at a temperature of 121 °C delivered by the process to the product in its final container with reference … Continue reading

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Quality Assurance activity in Pharma industry

Quality Assurance Department handles the following activities :: Technology Transfer : Receipt of product design documents from Research Centre (RC). Distribution of documents received from RC. Checking & approval of documents generated based on RC documents i.e. Batch Manufacturing Record. … Continue reading

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