Achieving top-class value with your health-products manufacturer

OCTOBER 19, 2016

The manufacturing process of complementary and alternative medicines (CAMS) and health supplements must adhere to strict regulations and quality standards set out by Good Manufacturing Practice (GMP). The Health Products Association of South Africa (HPASA) is committed to developing and maintaining standards that support and foster these regulations, and that work towards an ethical, credible and relevant health-products industry in South Africa.

Wayne Robinson, newly appointed HPASA Director of Scientific and Regulatory Affairs and the voice of the HPASA with regard to legislative matters, has extensive insight into and experience in the manufacturing of CAMS and health products. Wayne qualified with a Bachelor’s Degree in Pharmacy from the University of the Witwatersrand and was Cum Laude in Production Management from Production Management Institute of Southern Africa. He has 15 years’ experience in the CAMS and pharmaceutical industry.

He is well versed in manufacturing, distribution, regulation and sales within this dynamic market. His experience has been gained from international and market leading South African companies: including GlaxoSmithKline; Alliance Pharmaceuticals; Pharma Natura; GNLD and Azochem Laboratories. Wayne has worked extensively in Africa including East African countries like Kenya and Tanzania and in Nigeria and Ghana in West Africa.

International training in Europe and America further highlighted Wayne’s belief that the South African manufacturing industry is capable of equalling the industry standards of first world environments. Wayne was the Operations Director at Azochem Laboratories, a leading CAMS Manufacturer and Packer, since 2009 and transitioned into the Sales and Technical Director Role in 2013. He now deals directly with clients, product development and regulatory issues.

“Having highly skilled and trained staff is essential to ensuring that the manufacturing process is of the highest standard from start to finish,” Robinson says. Supporting this philosophy, are his own manufacturing company’s professional personnel which include pharmacists, pharmacist assistants, microbiologists, engineers, and research and development (R&D) chemists.

Each manufacturing process begins with developing the product with the end user benefits in mind. This GMP principle of “Pharmaceutical Quality by Design” (QbD) means that quality is built into the product from the start.

It is essential that the sourcing of the correct product, raw and packaging materials, must be from approved and accredited suppliers. Having suppliers adhere the same GMP standards is imperative to maintain product integrity. The R&D, Quality-Assurance (QA) and procurement teams play a vital role in this first step. Verifying the input quality of the starting materials in the manufacturing process is of a high standard, ensures end product quality.

“The manufacturing facility and all equipment used must adhere to GMP quality standards and must be fit for purpose. The verification/validation of equipment makes sure the equipment runs efficiently and for its intended purpose. Validation also ensures that the process is repeatable within product limits and from batch to batch.

The design of the manufacturing facility is also essential to ensure that GMP is achieved. This design starts with the Class 8/ISO14644 HVAC (heating, ventilation and air-conditioning) systems, as well as full ISO-walled surfaces especially in primary manufacturing and packing areas. These controls help to create a clean-room environment that enables easy cleaning and limits cross-contamination from product to product,” says Robinson.

Throughout the manufacturing process, products must be monitored during and after each critical step by the QC & QA teams. This includes on-line manufacturing and packing QC checkers, lab analysts, microbiologists and a QA Manager.

“A thorough system, needs to be put into place, to ensure that every step of the process is rigidly & independently examined, so that the product or intermediates meet the approved specification prior to them being transferred to the next stage,” says Robinson.

QC & QA departments verify that the manufacturing process is independently monitored and that quality is maintained throughout manufacturing, packing, storage and distribution of the products.

Brand owners require that their products fulfil the dietary supplementation and health benefit that their consumers rely on. These finished products must have quality befitting a high CAMS standard and be received timeously, so they can be affordably priced and merchandised, ready for their targeted consumers. In order to give the customer the best value, GMP & QbD principles that build value into the system, should be applied at each stage and not just rubber-stamped at the end.