ALIDATION SOLUTIONS

About Us

MN Validation Solutions (MNVS) is a well-established consulting company in the pharmaceutical and cannabis industries in South Africa. Our main expertise is to:

  1. Provide technical support in the compilation of Site Master Plans and Validation Master Plans (Packing, Cleaning and Computer systems) in the pharmaceutical industry.
  2. Provide technical support in the compilation of Utilities manuals (Water, Air Handling Unit& Compressed air).
  3. Provide technical support in the preparation and review of Validation protocols (URS, FAT, SAT, DQ, IQ, OQ & PQ) and Standard Operating Procedures (SOP’s).
  4. Provide training in Validation related activities and/or Standard Operating Procedures.
  5. Provide technical support in temperature mapping studies for facilities (Warehouses, Cold Rooms, Manufacturing areas) and equipment (Fridges, Incubators, Sterilizers and Production Ovens).
  6. Assist in conducting Periodic reviews and Requalifications on rooms, equipment and utilities.
  7. Perform Validation activities meeting current Good Manufacturing Practice (cGMP) and regulatory requirements on manufacturing processes, packing processes, cleaning procedures and analytical methods used in the production of a pharmaceutical product.
  8. Provide technical support in the Qualification of facilities, utilities, equipment, computer and control systems deemed critical to the quality, safety, purity and efficacy of pharmaceutical products
  9. Assist in the development of Quality Management Systems (QMS) related to Validation activities covering the areas of Risk assessment, Corrective Action Preventative Action (CAPA) management, System Impact assessment, Customer Complaints and Audit findings.
  10. Assistance in getting cGMP and SAHPRA/EU licensing or accreditation for pharmaceutical and cannabis companies.

Our values

MN VALIDATION SOLUTIONS is focused on providing the best quality services in the Pharmaceutical sector with particular emphasis in validation and Quality assurance activities and process improvement projects.

Our Mission

We aim to provide quality and innovative solutions to the pharmaceutical industry in Africa by ensuring Validation, Compliance and Quality Management Systems standards are efficient.

Our Vision

To be the leading and renowned pharmaceutical consultants in Africa through Validation, Quality and Compliance.

Objectives


Our People

Mr. Mthokozosi Ncube

Managing Director

Mr. Ncube is an experienced Pharmaceutical consultant with a great passion for the pharmaceutical industry who has extensive knowledge in quality, validation and compliance towards cGMP requirements and quality standards and has served in well renowned organizations. He has vast experience in Validation projects, cGMP audits, Packing Validation, HVAC qualification, Equipment qualification, Process Validation, Compressed Air Qualification, Facility qualification, Temperature mapping and Quality Management Systems (QMS).

Mr. Ncube has equipped himself with modern skillset and knowledge to be competent in the pharmaceutical industry where it is continuously evolving because of continuous improvement of cGMP requirements and updated guidelines. Mr. Ncube holds an Bachelor of Commerce Honors degree in Management and a few number of courses from various institutes and thus he is well versed with current techniques, skills and standards.

Contacts

+27 63 651 9598 | +27 60 330 4097

mthokozisi@mnvalidationsolutions.co.za

+27 63 651 9598