PM PROjEN’s long experience and understanding of GMP and Validation requirements in the Pharmaceutical sector are such that clients’ can rest easy that the introduction of new processes and equipment are undertaken efficiently and effectively and in such a manner that the new system can be fully validated in accordance with regulatory requirements.
Validation activities include:-
- Validation master planning
- Design qualification and GMP reviews
- Installation qualification
- Operational qualification
- Performance qualification
- Process validation
- Protocol and procedures writing
- Prospective, retrospective and routine validation studies
- Training for validation
- Construction auditing
- Factory and site acceptance test witnessing.