Process Validation Stages process qualification protocol

During Process Validation the protocol of process qualification is also prepared, following are some of the points which are included into protocol of process qualification, so let us check it out some points:

The manufacturing condition including processing limits, the operating parameters as well as the components used such as raw materials are included in protocol.

The sampling plan with complete details of the number of sampling points, frequency of sampling of each unit are to be mentioned in protocol.

The number of the samples should be adequate in order to provide sufficient statistical data.

The description of the statistical method to be used should be mentioned in protocol.

Design of facilities and the qualification of the utilities and equipment must be available.

Training records of personnel during handling or operating of the equipment must be present.

Verification of materials in use.

Status of the validation of the analytical methods should be available.

Review and approval of the protocol.

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