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 →

Some useful guideline reference for Pharmaceutical industry but not limited to....

CQA : Corporate Quality assurance PV : Pharmacovigilance MK : Marketing QA : Quality assurance

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 →

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 name

Note : Same procedure can be followed for Filled Capsules Reference Supplementary guidelines on GMP: validation, non-sterile process validation. In: WHO ExpertCommittee on Specifications for Pharmaceutical Preparations: forty-ninth report. Geneva: WorldHealth Organization; 2015: Annex 3 (WHO Technical Report Series, No. 992)

1.0 Introduction Cleaning is necessary to avoid cross contamination from one product to another. Cleaning process used for cleaning of equipment needs to be established to ensure that it is capable of consistently achieving desired level of cleanliness, to ensure the state of cleaning Hold time Study is required. This validation study to be executed … Continue reading Hold Time Study of Cleaned Equipment (CEHT) →