Month: April 2023
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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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What is Air handling unit
What is Air handling unit? Air handling unit is a part of HVAC system (Heating ventilation and air conditioning system)Air handling unit processes the air by air filtration, cooling, dehumidification and temperature control. Purpose of AHU is to provide clean air that meets the requirements of clean room classification as per ISO. Air is filtered,…
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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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USFDA withdraws approval of drug Makena
USFDA withdraws approval of drug Makena, Pharmaceutical company failed to submitte post market study, to evaluate saftey and to confirm the efficacy to FDA. USFDA withdraws approval of drug Makena, the drug approved under accelerated approval pathway. The drug Makena is now no longer an approved drug, the drug was used for treatment as a…
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Air Pressure Difference between clean room
How to maintain air pressure difference between clean rooms and passages and air locks? Here is the systematic approach for maintaining the air pressure difference between clean rooms and air locks and passages before that lets understand that, the main function of a clean room is to prevent cross contamination, therefore clean rooms are supplied…
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Risk assessment tool FMEA and FMECA
Risk assessment tool FMEA FMECA, Failure mode effect analysis (FMEA ) Failure mode effect criticality analysis (FMECA ): How to do risk assessment? What is Risk Assessment tool FMEA FMECA, the Failure Mode Effect Analysis? Failure mode effect analysis (FMEA) as the word suggests this tool used for assessing the risk associated with the pharmaceutical…
Guidelines on Pharmaceutical Manufacturing Pharma Quality Assurance Quality Management System 