QA & GMP Compliance
- Quality Management System – Design & Effectiveness Reviews
- GMP Audits – Process Design, Review & Performing (Vendors, Suppliers, Service Providers, Mock Regulatory Inspections, Data Integrity, Sterility Assurance)
- GMP Risk – Gap Analysis & Mitigation Plans
- Training – GMP Compliance, QMS, Data Integrity, Special – Sterility Assurance
GMP is a regulatory framework which ensures that the production, processing, packaging and storage of pharmaceutical products is safe and effective. All pharmaceutical product manufacturers must establish and demonstrate adequate controls in the form of systems, procedures and processes to comply with these regulations.
Good Manufacturing Practice (GMP) is one of the basic and mandatory regulations within the life sciences industry. The pharmaceutical product manufacturers not complying with the requirements of Good Manufacturing Practice (GMP) have been hitting the headlines for all wrong reasons. The knowledge of GMP guidelines and whether your manufacturing operations are GMP compliant is invaluable for your business and reputation.