Risk Based Joint Inspection Part 2
Pharmaceutical building and premises require meticulous design and construction. Key considerations include…
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Referance Document
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Risk Based Joint Inspection Part 1
The Risk-Based Joint Inspection of CDSCO in Pharma refers to a strategic approach to pharmaceutical inspections…
Pharmaceutical Definitions
Batch (or lot)
A defined quantity of starting material, packaging material, or product processed in a single…
QUALIFICATION OF PROTOCOL CUM REPORT OF COMPRESSED AIR GENERATION AND DISTRIBUTIONSYSTEM
Compressed air qualification in the pharmaceutical industry is a critical process to ensure that the air used in…
DOWNLOAD QUALIFICATION PROTOCOL OF DISPENSING / SAMPLING BOOTH (RLAF)
PERFORMANCE QUALIFICATION OF DISPENSING / SAMPLING BOOTH (RLAF)
Reverse Laminar Airflow (RLAF), also known as a…
DOWNLOAD AREA QUALIFICATION PROTOCOL IN PHARMA
Area Qualification in the pharmaceutical industry is a critical process that ensures that specific areas within…
Download Analytical Method Validation / Verification Protocol
Analytical methods include identification test, quantitative test for impurities,limit test for impurities,…
Download Microbial Limit Test (MLT) validation Protocol
Microbial Limit Test (MLT) validation in pharma is the process of verifying the suitability and effectiveness of…
Download the Disinfectant Validation Protocol
Disinfectant validation is the process of verifying the effectiveness of a disinfectant or sanitizer against…
Download Sterility Test Method Validation Protocol
Sterility Test Method Validation is the process of verifying that a sterility testing method is capable of…