Good Manufacturing Practice (GMP) ensures that goods are consistently manufactured to meet their predefined quality standards to be safe and effective for their intended use. It is vital that GMPs are continuously monitored to ensure that they comply with requirements imposed by the health authorities.
SeerPharma’s team of auditors can address GMP requirements across the manufacturing lifecycle from the early delivery of starting materials to the distribution of finished product drugs or devices to the end-user.
The following are the typical regulations and standards to which SeerPharma is requested to audit against:
Regulations and Standards
- PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S Guide to GMP)
- FDA 21 CFR Part 211, Part 56, Part 820
- ICH Quality Guidelines including but not limited to:
- ICH Q9 Quality Risk Management
- ICH Q10 Pharmaceutical Quality System
- ISO 9001, ISO 13485, ISO 14644, ISO 14971, ISO 17025, ISO 31000
- Australian Code of Good Manufacturing Practice for Human Blood, Blood Components, Human tissues and Human cellular therapy products (the Australian Code of Good Manufacturing Practice)
- Australian Code of Good Manufacturing Practice for Veterinary Chemical Products
Contact us to learn more about our GMP auditing services, or click the below button to learn about our range of GxP auditing services.
