Follow
To lay down the procedure for facility qualification
Responsibility:
> Engineering Manager or his/her designee will be responsible for initiating facility qualification.
> Validation manager will be responsible for checking sufficiency in protocols and reports and requirement of facility qualification exercise.
> Quality Assurance Manager will be responsible for checking possible impacts on product quality and assurance of current Good Manufacturing Practices in facility qualification exercise.
> Quality Control Manager will be responsible for providing chemical and microbiological analytical support to facility qualification exercise.
> ProductionWarehouse Manager will be responsible for checking possible impacts on process coming through facility qualification exercise.
> Environment, Health and Safety (EHS) Manager will be responsible for safety and sanitation issues of the facility and minimization of impacts of operation on environment.
> Engineering officer will be responsible for preparation of protocol and report.
> A team of Engineering, production, EHS and QA officer will be responsible for facility qualification exercise.
> Executive Director, Quality will be responsible for of review necessity of the exercise, result and recommendation of report and give the approval in protocol and report.
Precautions:
> The engineering officer who has sufficient knowledge on current Good Manufacturing Practices, HVAC system, clean room technology, materials of construction, in-house practices and different engineering approaches related to finished pharmaceuticals manufacturing units should be involved in facility qualification.
> All critical attributes should be considered in facility qualification.
> Test(s) to be performed both for resting and operation conditions.
> Challenge test(s) to be done based on scientific reasoning.
> Relevant current SOPs should be followed in each steps of facility qualification. If there are no relevant SOPs for a certain step, cGMP and scientific procedure should be followed with proper justification.
> It should be ensured that the facility is usable for manufacturing, packing and/storage of pharmaceuticals.
Procedure:
> Engineering officer will prepare a protocol for facility qualification. Manager of Engineering, Production, Quality Control, Validation and Quality Assurance will check the document as per the responsibility defined in the SOP and forward to Executive Director, Quality for approval.
> Protocol should consider following matters
> Review of layouts of the facility to ensure suitable size and space for orderly placement of equipment and materials to prevent mix ups between different components, drug product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination. Change room(s) and related facilities should be sufficient to ensure personal hygiene, cleanliness, and gowning and other change procedure to minimize risk of contamination.
> Review of layouts of the facility to ensure dedicated area for
a) Receipt, identification, storage and withholding from use of components, drug product containers, closures, and labeling, pending the appropriate sampling, testing, or examination by the quality control unit before release for manufacturing or packaging
b) Holding rejected components, drug product containers, closures, and labeling before disposition
c) Storage of released components, drug product containers, closures, and labeling
d) Storage of in-process materials
e) Manufacturing and processing operations
f) Packaging and labeling operations
g) Quarantine storage before release of drug products
h) Storage of drug products after release
i) Control and laboratory operations
j) Aseptic processing, which includes as appropriate
