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Message History
In pharmaceutical manufacturing, the product must not be contaminated by previous product as well as it should not be contaminated with the cleaning agent used for equipment cleaning.
To verify the cleaning process it is validated by taking the sample fro...
Concept of Revalidation in PharmaceuticalsMar 17, 2025
The revalidation process is essential to maintain the validated status of the plant, equipment, manufacturing processes, and computer systems. It should be as important as calibration and maintenance.
Possible reasons for starting the revalidati...
Transport Validation for Pharmaceutical ProductsMar 17, 2025
In the past, it was not important to validate the transportation of the pharmaceutical products but now it is recommended by all major regulatory agencies. Storage conditions during transit of the pharmaceutical products should be validated because it may ...
FDA Warning Letters for Cleaning ValidationMar 17, 2025
Cleaning of equipment was first published in the Code of Feral Regulations (CFR) as 21CFR211.67 Equipment Cleaning and Maintenance in 1978. After that a lot of document guidelines are published on cleaning validation and nowadays cleaning validation is the...
Cleaning Validation of Pharmaceutical EquipmentMar 17, 2025
The Cleaning validation is performed to demonstrate the effectiveness of procedures for cleaning to remove the residue of the previous product.
After the process, equipment used for manufacturing of the product shall be cleaned as mentioned in respectiv...
