Good Manufacturing Practice (GMP) is an international standard that governs all the activities related to product quality.
The South African Regulatory Authority describes GMP as “That part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the medicine registration or product specification. GMP is concerned with both production and quality control”.Depending on the business and its intended activities, all pharmaceutical companies in South Africa require licensing with both the Medicines Control Council and the Department of Health. We assist with the following:
- Preparing & reviewing:
- Site Master Files
- Standard Operating Procedures
- Licence Applications
- Licence Renewals
- Conducting and assisting with:
- Inspections at 3rd party suppliers
- Local & Foreign Manufacturer Audits
- Warehouse & Distribution Facility Audits
- Advising during planning stages of activities and envisaged growth or diversification.
HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.