RegiPharm

  • Orthodox / Allopathic Medicines

    There are particular requirements and processes involved during the registration process for medicines in South Africa and we offer the following services...

  • Complementary Medicines

    Our aim is to clarify the often confusing issues surrounding the complementary medicines industry. We assist our clients to comply with the current requirements for their individual needs. Our clients have come to rely on our expert advice and prompt service.

  • Cosmetics

    We can assist with evaluation of ingredients, claims, advertisements and labelling, taking into account the ASA (Advertising Standards Authority) Code of Advertising Practice.

  • Foodstuffs

    All foodstuffs are controlled by the Foodstuffs, Cosmetics and Disinfectants Act, Act 54 of 1972, which controls the manufacture, importation, marketing and sale of foodstuffs.

  • Veterinary Medicines, Farm Feeds and Stock Remedies

    There are particular requirements and processes involved during the registration process in South Africa we can assist with the following...

  • Licensing of Facilities and GMP

    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.

Licensing of Facilities and GMP

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
    • Quality Manuals
    • Standard Operating Procedures
    • Licence Applications
    • Licence Renewals
  • Conducting and assisting with:  
    • Self-Inspections
    • Inspections of 3rd party suppliers
    • Local & Foreign Manufacturer Audits
    • Warehouse & Distribution Facility Audits
  •  Consulting during planning stages of activities and envisaged growth or diversification.
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