Category: Quality Management System
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Installation Qualification IQ
What is Installation Qualification? When installation qualification is done? Definition of Installation qualification: Installation qualification IQ is a part of the validation process of equipment, system or the manufacturing area where the equipment is verified for its compliance with respect to its design, operation and correctness after the equipment system or the area is installed…
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User Requirement Specification
What is User Requirement Specification? URS is abbreviation for “User requirement specification” in pharmaceutical manufacturing, before procurement of any machine or commissioning of any department area, clean room or any equipment, Each and every requirement of the department area clean room or equipment is mentioned in clear details, in a document, this document after listing…
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Annual product quality review
Points which are ignored during preparation of Annual product quality reveiw APQR. Annual product quality review APQR is very important document it’s not mandatory document yet it is demanded by almost all regulatory agencies, as a part of comiance to Guidelines issued by WHO and USFDA. The purpose of preparing an annual product quality review…
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Recall Classification Mock Recall
Recall Classification Mock Recall detail information. Q: Why are Pharmaceutical Product is Recalled by pharmaceutical manufacturing companies? Q: What is the Mock recall? How mush is Time limit set by FDA for recall? Classification of Recall in pharmaceutical. Give procedure for doing mock recall. Q: What is type1, 2,3 recall or What is Class A,B,C…
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Document Control System in a Pharmaceutical Company
Documentation control In a Pharmaceutical Manufacturing Company Standard operating procedure is the originator of the documents, in a standard operating procedure instructions are provided for doing an activity. In the same SOP a format is provided for monitoring the parameters of the activity with time etc. This is there in the SOP at the end…
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Quality management system in Pharmaceutical Company
Quality management system in a pharmaceutical manufacturing company What is quality management system QMS in pharma company? Following functions all together when driven together forms, every function is more or less interlinked or impacting other, therefore systematic operating of every function is important to achieve compliance and quality aspects as defined in guidelines of regulatory…
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Important aspects of Deviation how to handel
What you should know for effective handling deviations in a pharmaceutical company Definition of Deviation: Any observed and non-observed departure of value or an event or procedure or action from set parameter, written and approved standards or acceptable limits or statements is called as deviation. If someone do not follow or finds a difference in…
Guidelines on Pharmaceutical Manufacturing Pharma Quality Assurance Quality Management System 