Category: Validation
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Media fill aseptic filling validation
What is media fill aseptic process simulation, why media fill run is conducted in sterile dosage form filling. Detail information on media fill aseptic filling Validation: Media fill aseptic filling validation is a type of validation in sterile dosage form filled aseptically, where the product is filled in aseptic condition, media fill run has many…
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Operation Qualification and Performance qualification
What Is Operation Qualification and Performance qualification? Let’s understand what is operation Qualification Performance qualification, for an equipment, instrument or and clean room area itself, approval of an URS, Design qualification, installation Qualification, Operational Qualification and Performance qualification are steps in the equipment validation process. These all together form the validation process of an equipment…
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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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Design qualification DQ
What is DQ and its importance? Understanding The purpose of design qualification DQ. Any equipment used in pharmaceutical manufacturing, is developed and engineered with the intended objectives. The objectives behind the designing an equipment is clearly defined in the user requirement specification (URS). The specifications and requirements listed in URS are the tests which the…
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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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Hold time study in cleaning validation
Hold time study for clean and unclean equipments must be carried out during cleaning validation. It’s one of important aspect that many pharma companies forget to do Hold time study for clean and unclean equipments during Cleaning Validation. What is Clean equipment hold time dirty equipment hold time ? During validation of cleaning procedures, hold…
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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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Isolator systems Isolator Validation in pharmaceutical manufacturing technical guide
What is an Isolator in pharmaceutical manufacturing? how to do validation of Pharma Isolator As the name suggests, an isolator is an equipment designed to isolate a drug product during manufacturing from the external environment in the clean room. Isolators separate the drug product from the external environment and protect the drug product from getting…
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Clean Room Validation Recovery test
How a recovery test is done during validation of AHU/clean room in pharmaceutical manufacturing? Recovery test in AHU or clean room validation is a test where the ability of the clean room or AHU to maintain the level of cleanliness or the particle count below the rated classification limit. In the process clean room is…
Guidelines on Pharmaceutical Manufacturing Pharma Quality Assurance Quality Management System 