BET and sterility validation of microbiology
BET and sterility validation of microbiology consists of the following:-
Protocol No. for BET and sterility validation should be written in format PR/MV/AA/ BB/CC/DD and report No. should be written in format RP/MV/AA/ CC/DD .
PR refers to protocol, RP refers to Report,
MV refers to microbiology validation.
AA refers to type of validation or Product name,
BB refers for the Product code ,
CC refers Protocol no.
DD refers to revision no. of the protocol.
Revision No. of the protocol go through the proper change control procedure refer SOP on change control procedure SOP. For details of Protocol No. SOP on document numbering.
Protocol of the validation consists of the following
- Protocol Approval
- Validation Team
- Training Record
- Pre – Validation Requirements
- Acceptance Criteria
- Validation Procedure
- Validation Report & List of Exhibit
- Revalidation Criteria
- Observed Deviation
- Reference Documents (If Any)