VALIDATION PROTOCOLS & GUIDELINES
Validation of new equipment or an area for storage of TTSPP's requires IQOQPQ or mapping to be completed prior to use in your facility. Each stage of the qualification must have a protocol. This means individual Protocols will be needed to be written and approved by the company seeking the Qualification prior to beginning the execution stages. One for each of (IQ) Installation Qualification; (OQ) Operation Qualification; (PQ) Performance Qualification and a Mapping Protocol which is a step within the Operation/Performance Qualification. Some of the standard Guidelines to meet for the acceptable criteria for a protocol or for the period of the mapping study are the ICH Q1A(R2) Q6A & Q6B. WHO & Health Canada QAS/14.598 Supplement 7 & 8, cGMP, GUI009 etc.
TYPICAL FORMAT FOR A QAULIFICATION (IQOQPQ) INCLUDE THE FOLLOWING:
Prepare, review and approve a detailed and comprehensive protocol before the qualification process begins.
The qualification protocol should be a comprehensive document, which guides the user through the IQ, OQ and PQ processes and helps ensure that all temperature-controlled storage areas are correctly qualified. Each of the three protocols can be more or less generic. However generic documents should never be used unwisely; they should always be adapted to the specific type of temperature-controlled storage area; each installation must be linked to and qualified against its own specific qualification protocol.
The qualification protocol should include the following sections:
MAPPING REPORT TEMPLATE
The protocol should contain a template for the mapping report. This should include the sections listed below: