1.0 Approval The user requirement specification for Compression Machine for Compression of Blend which is to be used in Production Area have been prepared, reviewed, approved & authorized by concerns from the following area. 2.0 Scope: The URS document is generated by the User to provide details of structural, functional, cGMP and statutory requirements … Continue reading User Requirement Specification for Compression Machine
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User Requirement Specification for Rapid Mixer Granulator (RMG)
1.0 Approval The user requirement specification for Rapid Mixer Granulator (RMG) for Mixing, Wet Binding & Size reduction which is to be used in Granulation Area have been prepared, reviewed, approved & authorized by concerns personnel from Production, Engineering and QA. https://pharmaceuticalupdates.com/2020/04/27/working-and-principle-of-rapid-mixer-granulator-rmg/ 2.0 Scope: The URS document is generated by the User to provide … Continue reading User Requirement Specification for Rapid Mixer Granulator (RMG)
Preparation of a Site Master File as per MHRA
These notes are intended to provide guidance on the recommended content of the SiteMaster File. A requirement for a Site Master File is referred to in Chapter 4 of the GMPGuide. INTRODUCTION1.1 The Site Master File is prepared by the pharmaceutical manufacturer and shouldcontain specific information about the quality management policies andactivities of the site, … Continue reading Preparation of a Site Master File as per MHRA
Human Error Evaluation Flow Chart
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Ten important tips for HPLC Mobile Phase
Guideline Reference in Pharmaceutical industry
Some useful guideline reference for Pharmaceutical industry but not limited to....
Market Compliant Process Flow
CQA : Corporate Quality assurance PV : Pharmacovigilance MK : Marketing QA : Quality assurance
Types of Airlocks in Pharmaceutical Manufacturing Plants
Definition of Airlock: Commonly used in the pharmaceutical industry to maintain cleanliness and prevent contamination of the manufacturing environment. Airlock is a small, enclosed space that is used to transition between clean and non-clean areas. It typically consists of two or more doors that can be opened and closed to allow personnel or material to … Continue reading Types of Airlocks in Pharmaceutical Manufacturing Plants
Vendor Management Flow Chart
Abbreviations : FRD : Formulation Research Development ARD : Analytical Research Development CQA : Corporate Quality Assurance COA : Certificate of Analysis Note : Consider FPL as Site name or Organization nam
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