Académique Documents
Professionnel Documents
Culture Documents
Name of Manufacturer
Physical Address
Date of inspection
Purpose of inspection
(To be To be filled
filled by by Auditor
Auditee)
1.0 QUALITY ASSURANCE
2.0 PREMESIS
2.1 (DESIGN & LAYOUT OF
FACILITIES)
Does the facility have proper design,
layout and finishes based on
contemporary standards to:
2.1.1 Manufacture high quality medicine.
2.1.2 Avoidance of cross contamination.
2.1.3 Proper cleaning, drainage and
sanitizing.
2.1.4 Ventilation, air conditioning and
maintenance.
2.2 Is there emergency power supply
available to take care of entire energy
Zeeshan Nazir Page 4
demand or at least critical areas?
2.3 Does the facility have appropriate
controls to maintain required
parameters e.g. temperature, relative
humidity and pressure differentials
etc?
2.4 Are the doors, windows, walls, ceiling
and floor such that no holes or cracks
evident (other than those intended by
design)?
2.5 PLANT SAFETY & SECURITY
2.5.1 Does the facility have safety
program?
2.5.2 Are safety procedures written?
2.5.3 Do employees receive safety
orientation before working in the
plant area?
2.5.4 Does the facility have a formal,
written security policy?
2.5.5 Is access to the facility restricted?
2.6 SANITATION
2.6.1 Is written sanitation program
available on the premises?
2.6.2 Is sanitation program is implemented
and effective in preventing
conditions?
8.0 SAMPLE
12.3 COMPLAINTS
Are complaints and other information
concerning potentially defective
products carefully reviewed according
to the written procedures?
14.1 EQUIPMENTS
14.1.6 EQUIPMENT/INSTRUMENTS
CALIBRATION & PREVENTIVE
MAINTENANCE
14.8 MANUFACTURING
(STERILE PRODUCTS)
Is environmental monitoring
equipment on a maintenance /
calibration program?
14.13 INSPECTION
14.15 PACKAGING
14.15.1 Is the packaging line equipped with
capping equipment?
14.17 PACKAGING
15 REPROCESSING