SIX Golden Rules of Validation

1.0 DRAFT A PERFECT PLAN FOR VALIDATIONS

Normally, entire validation activities in any organization is performed using

Master Validation Program. If MVP is perfect, success in validation is assured. Exercise following precautions in drafting MVP

Avoid Critical Miss Outs:

Many of MVP,s have critical miss outs. Very often atypical MVP includes Equipment validation, Process validation, HVAC & Water system validations and Method validation but misses out Computer System validation. Some MVP,s even do not provide scope for revalidation. Retrospective validations for the existing system and equipments are also missed out many times.

Specify frequency of Validation/ Revalidations.

Master validation Plan shall provide clear statement of frequency of Validation / Revalidation so as to ensure that systems are maintained in validated state through out their life cycle.

Provide detailed information on validation team

MVP shall clearly state Name/ Designation of validation team members and their individual and joint responsibilities.

Cover all the critical validation activities

The validation activities require the following steps

· Drafting validation protocol

· Approval of the protocol.

· Experimentation and observation as per the protocol.

· Recording of results

· Interpretation of results

· Comparison of results with acceptance criteria.

· Remarks

· Final validation report(validation summary and recommendation

Final certification and approval by all team members