SteriPack Contract Manufacturing offer Process Validation Services to the Medical Device and Pharmaceutical Industries globally. Process Validation requires assurance through documented evidence to prove validation compliance with relevant regulatory requirements. SteriPack Contract Manufacturing has a successful track record of implementing a corrective validation approach.
Whether you’re introducing a new product, transferring a line, or bringing an existing line our expert validation team will provide you with up to date policies and procedures.
At SteriPack Contract Manufacturing, we provide a full range of services including:
- Process Design
- Manufacturing Design
- Risk Analysis (pFMEA)
- Equipment Sourcing and Validations
- Validations (DoE, VP, IQ/OQ/PQ)
- Quality Management
- Validations & Qualifications Control
- Regulatory Compliance
- CE marking, 510K submission
Specific country regulatory compliance (JPAL, CAN/CSA)