Procedure for Establishing a Manufacturing Site License
The license for the manufacturing site is granted by the NHPD (Natural Health Product Directorate). This body approves the quality system built by the manufacturing company’s QA (Quality Assurance) specialist, as per GMP requirements. The QA specialist’s qualifications must first be recognized by the NHPD, which deems the specialist as possessing the necessary academic training and experience to carry out this role.
The Quality system is governed by the SOPs (Standard Operating Procedures). It is mandatory that all parties involved in the production of finished products follow these procedures.
What is the Key to success for conforming to GMP principles?
To conform to GMP principles, we must follow the SOPs as they relate to:
- Building(s) and equipment
- Production processes
- Records and documentation