Selection of directives applicable to the products, preparation of
design data of the products, preparation of Technical file, training to
the employees, Risk assessment manufacturing and QC
procedure,product safety, EC declaration for conformity (incase of
MDD) Nomination of EU representative, product labeling as per CE
mark, Inspection and testing as per directives, product standard
implementation, updating of technical file as and when changes in
the design.
WHO GMP
Who GMP
World Health Organization based Good Manufacturing Practices.
Applicable to
All food and pharmaceutical industries including bulk drug units.
Certification issued by
Drug Controllers/FDA Commissioners of the concerned states
Requirements
Compliance with the requirements of schedule applicable
considering product manufactured, validation of process and
products, maintaining controlled environment, calibration of
instruments, Preparation and follow-up of SOP's, preparation of site
master file, separate area for dispensing, manufacturing, QC etc.
Maintaining Master formulaic card and Batch manufacturing records,
follow-up of sanitation schedule and hygienic conditions, Microbiol
tests of the products.
OHSAS 18001
OHSAS 18001
Occupation health and safety Management system
Applicable to
All types of manufacturing and service organization
Certification issued by
Accredited Certifying Body
Requirements
Implementation of all applicable health, safety legal requirements,
Hazard Risk, assessment and evaluation, Documentation, SOP to
control risk, Health check-up of employees, Management plans,
15