Standard Operating Procedures are like a GPS system, they instruct us how to get there.
Let us give you two good reasons why we offer them:
You will undoubtedly be requested to show your SOP index to SAHPRA during a regulatory Good Warehouse Wholesale and Distribution Practice audit.
We are fortunate that we have all of them available. The author is Hevan van der Westhuizen ex Chief Medical Control Inspector for the MCC. Hevan is now retired and no longer with SAHPRA but is still consulting. He was involved in drafting the South African 2016 GWP guidelines.
Our SOPs were compiled in compliance with the official Good Wholesaling/ Distribution Practice Guidelines of the South African Health Products Regulatory Authority (SAHPRA) namely:
(i) SAHPRA Guideline No. 4.02: South African Good Wholesaling Practice for Wholesalers, Version 2, July 2016;
(ii) WHO Report Series No. 961, 2011, Annex 9: Model guidance for Storage and Transport of Time- and Temperature- Sensitive Pharmaceutical Products;
(iii) WHO Technical Supplements No. 1-16 to WHO Report Series, No. 961, 2011; and
(iv) The PIC/S Guide to Good Distribution Practice for Medicinal Products, June 2014.
Meet Hevan van der Westhuizen...
Hevan is a registered pharmacist with the SA Pharmacy Council. He has an excellent background in the fields of community pharmacy, hospital pharmacy, wholesale pharmacy, manufacturing pharmacy and regulatory affairs.
He also obtained a Certificate in Total Quality Management (TQM) from UNISA.
Hevan joined the Inspectorate Division of the Medicines Control Council (now known as SAHPRA) in 1988 and retired in 2009 after a service of 21 years with the said regulatory authority.
During his tenure as Chief Medicines Control Officer, his responsibilities (to name but a few) included the following-
International Narcotics Control Board (INCB): annual estimates, issue of import & export permits, manufacturing permits and scientific research permits for narcotic drugs and psychotropic substances;
Law Enforcement: import and export control of medicines at national land/sea/ air border posts;
Certificates: issue of GMP, Free Sale and Certificates of Pharmaceutical Products (CPPs);
Good Manufacturing Practice (GMP): inspections at local and international pharmaceutical manufacturing facilities. International inspections were performed in countries like Argentina, Egypt, Israel, Jordan, Pakistan, India, China and Taiwan. Performed joint GMP inspections with the FDA (USA); TGA (Australia); MHRA (UK) and Austrian regulatory authorities at national and international levels.
Good Wholesaling Practice (GWP): inspections at local pharmaceutical wholesalers and distributors.
Since his retirement, he was involved in the following-
(a) on a contract basis at various wholesalers/ distributors as a Technical Advisor. His responsibilities included-
- Assessing their Quality Management System;
- Compiling the necessary SOPs;
- Developing and presenting training courses for “Warehouse Operation Management” for delegates from various African and South American countries involved in the PEPFAR program of President George W. Bush;
- Giving technical advice with regard to the South African Procurement Committee with regard to the sourcing and quantification of Antiretroviralsdonated to the SA Government by the PEPFAR US President’s Plan for Emergency Aids Relief program; and
- Training personnel in Good Warehousing and Distribution Practices.
(b) He was furthermore contracted-
(i) to compile the draft version of the current South African Good Wholesaling Practice for Wholesalers; Version 2, July 2016;
(ii) by GE Healthcare (Ireland) to perform pre-qualification audits at various pharmaceutical distribution warehouses in Nigeria and Tanzania;
(iii) by the George W. Bush PEPFAR program to audit governmental pharmaceutical distribution warehouses in Tanzania and Namibia; to train their personnel in Good Warehousing and Distribution Practices and to assist them with the development of their own Quality Management System;
(iv) to perform Good Manufacturing audits at pharmaceutical manufacturing facilities in Zimbabwe, India and Ukraine; and
(v) by various local pharmaceutical wholesalers/ distributors to compile SOPs as per SAHPRA requirements.