Follow
1.0 OBJECTIVE
To lay down the procedure for facility qualification.
2.0 SCOPE
All manufacturing, packaging, storage and other relevant area in (Compnay Name).
3.0 RESPONSIBILITY
3.1 Engineering Manager or his/her designee will be responsible for initiating facility qualification.
3.2 Validation manager will be responsible for checking sufficiency in protocols and reports and requirement of facility qualification exercise.
3.3 Quality Assurance Manager will be responsible for checking possible impacts on product quality and assurance of current Good Manufacturing Practices in facility qualification exercise.
3.4 Quality Control Manager will be responsible for providing chemical and microbiological analytical support to facility qualification exercise.
3.5 ProductionWarehouse Manager will be responsible for checking possible impacts on process coming through facility qualification exercise.
3.6 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.
3.6 Engineering officer will be responsible for preparation of protocol and report.
3.7 A team of Engineering, production, EHS and QA officer will be responsible for facility qualification exercise.
3.8 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.
4.0 ACCOUNTABILITY
4.1 Executive Director, Quality
5.0 PRECAUTIONS
5.1 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.
5.2 All critical attributes should be considered in facility qualification.
5.3 Test(s) to be performed both for resting and operation conditions.
5.4 Challenge test(s) to be done based on scientific reasoning.
5.5 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.
5.6 It should be ensured that the facility is usable for manufacturing, packing and/storage of pharmaceuticals.
6.0 PROCEDURE
6.1 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.
6.2 Protocol should consider following matters
6.2.1 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.
6.2.2 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
6.2.3 Review of material of construction and check the current status of floors, walls, ceilings or any other hard surface for smoothness and easy cleaning.
6.2.4 A temperature mapping exercise is to be performed to identify hot spots considering operations and to check temperature and relative humidity variability in worst case(s).
6.2.5 Review of status of all clean rooms and perform test against related specifications.
6.2.6 Review of layout of HVAC system. Any dust or smoke should not enter into premises again through air recirculation.
6.2.7 HEPA filters and perform integrity test.
6.2.8 Air pressure differentials and air flow rate.
6.2.9 Microbiological environmental monitoring for the facility.
6.2.10 Airborne particle count
6.2.11 Air changes per hour. Recycled air should be free from dusts and contaminants and should not exaggerate air quality. For example, carbon dioxide concentration in air should exceed acceptable limit.
6.2.12 Adequacy of lighting
6.2.13 Review of layouts for complaint and convenient man and material flow
6.2.14 Review of plumbing layouts to check
a) Possible contamination. The plumbing system should not have detrimental impact on the potable and purified water quality.
b) Sanitization procedure and records
c) Possible backflow in drainage system. Air break or other mechanical device should be effective to prevent back-siphonage.
6.2.15 Review of sewage, trash and disposal system.
6.2.16 Review of the safety and sanitary issue. EHS will review safety requirements, sanitizing exercise and will recommend additional requirement(s) to be followed. EHS will review impacts of environment of the operation of the facility and will recommend additional requirement(s) to be followed.
6.2.17 Review of entry/exit system. An effective system should be in place to ensure no unauthorized access to the facility.
6.2.18 Review of possible paths for infestation by rodents, birds, insects and other vermin. Review the preventive pest control procedure and program.
6.2.19 Review of procedure, report and status of cleaning and sanitation.
6.2.20 Review and checking of wash room and toilets for facilities of proper cleaning and personal hygiene. Wash room and toilets should be sufficient and easily accessible to working area and provided with sufficient water supply, cleaning agents and air dries or single-service towels, and clean toilet facilities.
6.2.21 Review of maintenance procedures and related precautions.
6.2.22 Review of changes, incidents, deviations and related corrective and preventive actions.
6.2.23 Review of validation and calibration status of equipments and utilities.
6.3 Facility qualification should be reviewed yearly. Facility qualification review will include followings
6.3.1 Review of changes in facility, incidents and related corrective and preventive actions.
6.3.2 Review of material of construction and check the current status of floors, walls, ceilings or any other hard surface for smoothness and easy cleaning.
6.3.3 Review of deviations of temperature and relative humidity and validity of temperature mapping.
6.3.4 Revalidation of HVAC system, laminar air flow systems, sampling booths, dispensing booths and hanging booths.
6.3.5 Review of microbiological environmental monitoring summary report(s). Microbiology will provide a summary report on environmental monitoring.
6.3.6 Review of safety and sanitation status report of the facility. EHS will review safety requirements, sanitizing exercise and will recommend additional requirement(s) to be followed. EHS will review impacts of environment of the operation of the facility and will recommend additional requirement(s) to be followed. Engineering department will ensure that there are no paths for infestation by rodents, birds, insects and other vermin.
6.3.7 Review of maintenance records, procedures and related precautions.
6.3.8 Review of validation and calibration status of utilities.
