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) →

Cleanrooms are specialized zones that are designed in such a manner that it has very low levels of particulate matter. These particulate entities may comprise of dust, airborne organisms, or vaporized particles. The cleanroom pass boxes are used for transporting items or components in and out of the cleanrooms. Apart from providing full protection, the … Continue reading Importance of Pass Box in Pharmaceutical industry →