Validation steps recommended in GMP guidelines:

  The validation steps recommended in GMP guidelines can be summarized as follows:

1.      As a pre-requisite, all studies shouldbe conducted in accordance with adetailed, pre-established protocol orseries of protocols, which in turn issubject to formal – change control procedures.

2.      Both the personnel conducting thestudies and those running the processbeing studied should be appropriatelytrained and qualified and be suitableand competent to perform the task assigned to them.

3.      All data generated during the course ofstudies should be formally reviewedand certified as evaluated againstpre-determined criteria;

4.      Suitable testing facilities,equipment, instruments andmethodology should be available.

5.      Suitable clean room facilities shouldbe available in both the ‘local’ andbackground environment. Thereshould be assurance that the cleanroom environment as specified issecured through initial commissioning(qualification) and subsequently through the implementation of a program of re-testing – in-processequipment should be properlyinstalled, qualified and maintained. 

6.      When appropriate attention has beenpaid to the above, the process, ifaseptic, may be validated by means of“process simulation” studies.

7.      The process should be revalidated atintervals.

8.      Comprehensive documentation should be available to define support and record the overall validation process.

Protocols should specify the following in detail:

o   The objective and scope of study.There should already be a definition ofpurpose.

o   A clear and precise definition ofprocess equipment system or subsystem, which is to be the subject of study with details of performance characteristics.

o   Installation and qualification requirement for new equipment.

o   Any upgrading requirement for existing equipment with justification for the change(s) and statement of qualification requirement.

o   Detailed stepwise statement of actions to be taken in performing the study (or studies).

o   Assignment of responsibility for performing the study.

o   Statement on all test methodology to be employed with a precise statement of the test equipment and/or materials to be used.

o   Test equipment calibration requirements.

o   References to any relevant standard operating procedures (SOP).

o   Requirement for the current format of the report on the study.

o   Acceptance criteria against which the success (or otherwise) of the study is to be evaluated.

o   The personnel responsible for evaluating and certifying the acceptability of each stage in the study and for the final evaluation and certification of the process as a whole, as measured against the pre-defined criteria.