BET and sterility validation of microbiology 

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
  • Overview
  • Objective
  • scope
  • Responsibility
  • Validation Team
  • Training Record
  • Pre – Validation Requirements
  • Acceptance Criteria
  • Validation Procedure
  • Validation Report & List of Exhibit
  • Revalidation Criteria
  • Observed Deviation
  • Reference Documents (If Any)
  • Abbreviations

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Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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