1. Quality Assurance Processes:
Manufacturers must have written policies and procedures in place to ensure quality and safety throughout all stages of production, from raw materials sourcing through final product delivery.
2. Document Control:
All documents related to the manufacture of APIs must be maintained according to regulatory guidelines and regularly updated as needed. This includes documentation for SOPs, change control processes, manufacturing batch records, etc.
3. Facilities and Equipment:
Manufacturing areas should adhere to detailed GMP requirements regarding facility design, maintenance, cleaning protocols, and equipment calibration/validation schedules.
4. Personnel Training:
Employees involved in the production should receive appropriate training on GMP regulations and processes so they can accurately complete their tasks.
5. Quality Control:
Manufacturers must perform quality control tests and inspections on all batches of APIs to ensure they meet the required standards for safety, purity, potency, and other qualities.
6. Raw Materials Sourcing:
All raw materials used in the manufacturing process must be sourced from approved vendors and must meet GMP requirements.
7. Environmental Monitoring:
Manufacturers should have a regular environmental monitoring program in place to ensure contamination of their products is minimized.
8. Supplier Management:
Manufacturers should have an effective system for managing their suppliers and ensuring that all components are supplied according to GMP standards.