THE MAGIC OF MINERALS
Minerals are inorganic substances that originate in the earth. These micronutrients are absorbed from the soil by plants, and people assimilate their benefits either directly by eating vegetables and fruit, or indirectly by consuming animal products. As the human body cannot manufacture minerals, they must be derived from food or supplements.
The HPA is to host vitally important GMP workshops in Johannesburg and Cape Town. Under the theme “A Practical Guide to GMP for CAMS & An Insight Into Stability”. The workshop will assist with understanding the procedures required GMP for CAMS focusing particularly on herbals and other complementary ingredients/products etc. It will give an insight into GMP requirements and Stability. This workshop is for any CAMS company personnel whether they be in marketing, sales, procurement or are manufacturers/raw material importers. It is essential that these two requirements are understood by all involved in the CAMS industry. The Workshop will de-mystify many concerns as companies/employees must ensure that they have the appropriate information as to how their products need to be GMP approved and also they should be assured that their contractors are GMP compliant and know what to look for. Companies need to know that they are part of the link in the Consumer Protection Act and should have an appropriate amount of knowledge for each process needed to put a product onto the market.
JHB: ASCENDIS HEALTH DIRECT TRAINING ROOM, TUSCANY OFFICE PK, 6 COOMBE PL. RIVONIA
CT: AMWAY TRAINING ROOM, 14 CHRISTIAN BARNARD ST. FORESHORE, CT
TIME: 10H00 – 15H00
COST: HPA MEMBERS: R500.00 for HPA Members- R250.00pp for every additional member from the same company: i.e. R500.00 x 1 member & R250.00 for each additional delegate from the same company
NON-HPA MEMBERS: R800.00 per non-HPA Member
(Includes: Refreshments & Conference Presentations)
09h30 – 10H00 REGISTRATION
10H00 -10H15 Welcome & Introduction: Wayne Robinson Technical & Regulatory Director, HPA
10h15 – 11h00 DEBBIE FLANDORP: QA Manager & Responsible Pharmacist with many years’ experience in the CAMS field. Principles of a GMP Environment as it relates to both local and international certification.
11h15-12h15 DERYCK SMITH : GMP Technical Advisor: Pharma Facility Services Self-Inspections. A guide to a self-inspection as it relates to the manufacturing process, equipment with special focus on HVAC and facility layout.
11h45- 12h15 DERYCK SMITH: This is a very practical presentation giving tips on what to look for when carrying out a self-inspection of the services and facility. The presentation will also be able to be used by manufacturers as a template for doing a self-inspection. This will mainly related to HVAC system or manufacturing equipment.
12h15 – 13h00 Refreshments
13h00 – 13h45 DEBBIE FLANDORP: Stability from a quality compliance and regulatory perspective
13h45 – 14h30 DR. HERMAN JULSING: Operational Director, Stabil Labs. Insight into Stability Testing from a storage perspective & simplified requirements
14h30-15h00 Questions & Answer and Close
Millennials vs. baby boomers: Differing opinions on nutrition
Consider how the attitudes and decision-making processes of older Americans differ from other generations when marketing and merchandising products to this group. http://www.newhope.com/market-data-and-analysis/millennials-vs-baby-boomers-differing-opinions-nutrition-infographic?NL=NP-01&Issue=NP-01_20170526_NP-01_857&sfvc4enews=42&cl=article_1&utm_rid=CNHNM000000584083&utm_campaign=21449&utm_medium=email
The future of supplements looks bright: From financial markets to self-regulatory initiatives
In this session, join U.S. Sen. Martin Heinrich, Houlihan Lokey’s William Hood, CRN’s Steve Mister, and NBJ’s Thomas Aarts and Rick Polito as they bring to light current and projected consumer trends, financial markets and new political realities for the supplement industry. For more: http://www.newhope.com/business-resources/future-supplements-looks-bright-financial-markets-self-regulatory-initiatives?NL=NP-03&Issue=NP-03_20170518_NP-03_382&sfvc4enews=42&cl=article_3&utm_rid=CNHNM000000584083&utm_campaign=21330&utm_medium=email
Phytosterol Supplementation Could Save EU Billions in Healthcare Costs
Costs associated with CVD could be avoided through more widespread supplementation among target populations. Read more: http://www.nutraceuticalsworld.com/live-from-shows/vitafoods-europe/2017-05-10/phytosterol-supplementation-could-save-eu-billions-in-healthcare-costs
Are these 5 natural product trends tipping mainstream?
See which concepts were top performers in New Hope Network’s NEXT Trend Concept Lab, which tests early-stage product concepts in mainstream consumers to predict their probability of success. Read more: http://www.newhope.com/market-data-and-analysis/are-these-5-natural-product-trends-tipping-mainstream?NL=NP-01&Issue=NP-01_20170517_NP-01_903&sfvc4enews=42&cl=article_4&utm_rid=CNHNM000000584083&utm_campaign=21314&utm_medium=email
Nutrition industry positive despite political uncertainty
Political and economic uncertainties have failed to dent optimism in the nutrition industry, according to research carried out exclusively for Vitafoods Europe 2017. Read more: http://www.nutraceuticalsworld.com/live-from-shows/vitafoods-europe/2017-05-04/nutrition-industry-optimistic-despite-political-uncertainty
In defence of homeopathy
Homeopathy has long been considered the easiest target of those not well predisposed to non-pharmaceutical medicine. For those who attack it, it’s a no brainer. There’s no measurable active ingredient, so homeopathy can’t work. Their blindness means they must ignore evidence of clinical effects or an effect from high homepathic potencies. Read more: http://anhinternational.org/2017/05/03/the-push-back-against-those-attacking-homeopathy-gathers-steam/?utm_source=The+Alliance+for+Natural+Health&utm_campaign=e3adb97039-EMAIL_CAMPAIGN_2017_05_03&utm_medium=email&utm_term=0_aea8a87544-e3adb97039-84966014
How to use experiential marketing to build your brand.
Being able to experience a product is one of the most powerful tools in marketing. Emma Andrews and Lynsey Walker of Pineapple Collective tell us why. http://www.newhope.com/business-resources/reach-out-how-use-experiential-marketing-build-your-brand?NL=NP-01&Issue=NP-01_20170502_NP-01_774&sfvc4enews=42&cl=article_3&utm_rid=CNHNM000000584083&utm_campaign=21116&utm_medium=email
Online Wellness Library product registry opens to public
The Council for Responsible Nutrition’s effort is aimed at increasing transparency and accountability. Read more: http://www.newhope.com/vitamins-and-supplements/online-wellness-library-product-registry-opens-public?utm_rid=CNHNM000000584083&utm_campaign=21086&utm_medium=email
The Future of Supplements Looks Bright: From financial markets to self-regulatory initiatives
In this session, join U.S. Sen. Martin Heinrich, Houlihan Lokey’s William Hood, CRN’s Steve Mister, and NBJ’s Thomas Aarts and Rick Polito as they bring to light current and projected consumer trends, financial markets and new political realities for the supplement industry.Read more: http://www.newhope.com/business-resources/future-supplements-looks-bright-financial-markets-self-regulatory-initiatives?NL=NP-01&Issue=NP-01_20170424_NP-01_537&sfvc4enews=42&cl=article_4&utm_rid=CNHNM000000584083&utm_campaign=21012&utm_medium=email
Self-regulation is par for the course in supplements
Like golf (and any sport), our industry is governed by a strict set of rules that all players are expected to follow and expect to be enforced. Read more: http://www.newhope.com/regulatory/self-regulation-par-course-supplements?NL=NP-01&Issue=NP-01_20170411_NP-01_256&sfvc4enews=42&cl=article_1&utm_rid=CNHNM000000584083&utm_campaign=20847&utm_medium=email
Nutrition Companies See Health Claims Regulation as Top Challenge in Europe
Nutrition companies view stricter EU regulation as a greater challenge than the state of the global economy, new research has shown. Meanwhile, Brexit is not widely expected to have a major impact on the European nutrition industry. – See more at: http://www.nutraceuticalsworld.com/contents/view_breaking-news/2017-03-28/nutrition-companies-see-health-claims-regulation-as-top-challenge-in-europe/?email_uid=f98c8c4262/list_id=396c189146/#sthash.ca5EHSSt.dpuf
Consumers swayed by ‘all natural’ food labels
A new study suggests that ‘natural’ claims boost consumers’ expectations of quality and nutritional content for products. http://www.newhope.com/news/expected-and-confirmed-consumers-swayed-all-natural-food-labels?NL=NP-01&Issue=NP-01_20170322_NP-01_517&sfvc4enews=42&cl=article_2&utm_rid=CNHNM000000584083&utm_campaign=20589&utm_
CRN addresses audience of Attorneys General
Association emphasizes importance of regulation enforcement and commitment to complementary self-regulation. – See more at: http://www.nutraceuticalsworld.com/contents/view_breaking-news/2017-03-21/crn-addresses-audience-of-attorneys-general/?email_uid=f98c8c4262/list_id=396c189146/#sthash.VIgXxT15.dpuf
Will the food industry be the climate savior?
The natural products industry must play a part in saving the Earth. Nutiva CEO John Roulac explains why and how to take the first step in doing so. http://www.newhope.com/news/will-food-industry-be-climate-savior?NL=NP-05&Issue=NP-05_20170222_NP-05_249&sfvc4enews=42&cl=article_1_1&utm_rid=CNHNM000000584083&utm_campaign=20165&utm_medium=email
First-ever supplements online product registry begins to take off
Nine unusual traits of high-performance natural food and nutraceutical organizations
Supplement raw materials growth outpaces supplement growth
Nutrition Business Journal’s 2017 Raw Materials Report tackles the front end of the supply chain. http://www.newhope.com/ingredients/supplement-raw-materials-growth-outpaces-supplement-growth?NL=NP-01&Issue=NP-01_20170210_NP-01_285&sfvc4enews=42&cl=article_1&utm_rid=CNHNM000000584083&utm_campaign=20028&utm_medium=email
250+ Example of Natural Remedies Beating Pharmaceuticals
Vitamin Supplements – rebutting fake prejudice
New EFSA Health Claims Guidance Makes Applying Easier, but Science Requirements Remain the Same.
Global Wellness Economy Estimated at $3 Trillion
The Global Wellness Institute (GWI) has released the 2016 Global Wellness Economy Monitor report, which measures and analyzes 10 markets (from fitness/mind-body to wellness tourism) that comprise the global wellness industry. Pre-released data revealed that the worldwide wellness industry grew 10.6%, to $3.72 trillion, from 2013-2015 (while the global economy shrank -3.6%), making it one of the world’s fastest-growing, most resilient markets, according to GWI. – See more at: http://www.nutraceuticalsworld.com/contents/view_breaking-news/2017-02-06/global-wellness-economy-estimated-at-3-trillion/?email_uid=f98c8c4262/list_id=396c189146/#sthash.Qp1az56F.dpuf
Organic & Natural Health Association takes a close look at ‘the most regulated of foods’
The role of activism in supplements and food was a key theme at O&N’s second annual conference. http://www.newhope.com/news/organic-natural-health-association-takes-close-look-most-regulated-foods?NL=NP-01&Issue=NP-01_20170202_NP-01_578&sfvc4enews=42&cl=article_1&utm_rid=CNHNM000000584083&utm_campaign=19890&utm_medium=email
A look at the first week of the Trump administration
The new administration roars out of the gate, but where it will take the supplement industry is far from clear. http://www.newhope.com/news/shock-and-huh-look-first-week-trump-administration?NL=NP-01&Issue=NP-01_20170130_NP-01_229&sfvc4enews=42&cl=article_1&utm_rid=CNHNM000000584083&utm_campaign=19805&utm_medium=email
Will organic supplements boom like organic foods?
Consumer supplement sales are projected to reach $52.5B by 2020
With more attention being placed on transparency, traceability and ingredient identity, the winners in 2020 will be committed to their science and ultimately build trust down the supply chain to the consumer. Find out where this market is heading in the State of the Raw Material Market infographic below, and get a full in-depth understanding of the supply chain in the 2017 NBJ Raw Materials Report.
Raising the Bar: CRN and IPA release best practice guidelines for probiotics
What supplements are millennials using?
Consumer research has told us that millennials are more likely than baby boomers to trust the supplement industry, but what supplements are they actually buying? Recent research from The Hartman Group sheds some light. http://www.newhope.com/market-data-and-analysis/what-supplements-are-millennials-using?NL=NP-05&Issue=NP-05_20170111_NP-05_141&sfvc4enews=42&cl=article_1_1&utm_rid=CNHNM000000584083&utm_campaign=19542&utm_medium=email
Twelve ingredient and supplement trends to look out for in 2017
Feed your business strategy with this outlook of a dozen natural and healthy crystal-ball trends about to take root:http://www.newhope.com/products-and-trends/12-ingredient-and-supplement-trends-look-out-2017?utm_rid=CNHNM000000584083&utm_campaign=19489&utm_medium=email
US Office of Dietary Supplements Outlines Five-Year Strategic Plan
Modest increase in zinc may reduce ‘wear and tear’ on DNA
John Foraker predicts what 2017 will bring for the natural products marketplace
Big Food can and will do well in natural, says Annie’s president as he forecasts what 2017 will bring for natural products industry M&A, investment and retail. http://www.newhope.com/food-and-beverage/john-foraker-predicts-what-2017-will-bring-natural-products-marketplace?NL=NP-05&Issue=NP-05_20170106_NP-05_300&sfvc4enews=42&cl=article_2_1&utm_rid=CNHNM000000584083&utm_campaign=19494&utm_medium=email
Another eventful year has passed at great speed. I am happy to report that good progress has been made in, inter alia, our quest for appropriate regulations, a relaunch of the HPA (with a new logo and impressive website), our media exposure and MCA membership.
Our Scientific and Regulatory Committee, under the directorship of Wayne Robinson, has been engaging with the Regulators via the ITG and has succeeded in effectively communicating our position – particularly vis-à-vis our concerns relating to Licensing and RP issues as well as the costs and complexity of compliance. This has been done in a non-confrontational atmosphere and in a spirit of cooperation.
Breaking news is that the SAHPRA General Regulations, which will incorporate CAMS, have been approved by the DoH/MCC and will be published in January with a 30 day comment period. This is great news, particularly for the HPA Exco members, as we can take a breather and avoid an analysis and rushed submission of comments during the holidays.
We are planning a series of regular workshops during 2017 which will focus on all the above issues.
We have had several meetings with and have built on our superb relationship with IADSA who offer us great assistance. Special thanks to Simon Pettman and Cynthia Rousselot for their input and friendship. They have also engaged with the Regulators and have been invited to return.
We have also worked closely with Ethicore, our political advisors, who have given us valuable insight into the current governmental complexities, political developments and strategic direction. Presentations made to our Exco and membership in both Johannesburg and Cape Town were well received.
Our membership base is increasing as is our capacity to enhance HPA membership benefits. SMAC has offered guidance and assistance to many of our members and our PR efforts are bearing fruit.
I would like to record my thanks and sincere appreciation to all HPA members, the Exco, Janet Welham and Deirdre Allen for their support during a difficult year. We have a very good team and will continue to strive for excellence.
I wish you all a superb and tranquil festive season, safe travelling and good health in 2017. May the New Year deliver exactly what you have in mind!
Norman Fels: Chairman
December 12th 2016
INTEGRATIVE MEDICINE – THE FUTURE OF HEALTHCARE
Integrative Medicine (IM) is an emerging paradigm in healthcare evolution. A growing trend amongst practitioners, IM is the combination of allopathic Western medicine and complementary and alternative medicine (CAMS). It moves away from the ‘either/or’ mentality and embraces a holistic approach that incorporates various therapies.
The Chairman & Executive Council of the Health Products Association are pleased to announce that
Wayne Robinson, has been newly appointed HPASA Director of Scientific and Regulatory Affairs and the
voice of the HPASA with regard to all legislative matters.
Robinson 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
Cum Laude in Production Management from Production Management Institute of Southern Africa.
With 15 years of experience in the pharmaceutical and CAMS industry, he is knowledgeable regarding
manufacturing, distribution, regulation and sales within this dynamic market.
Robinson’s experience has been gained from various companies including GlaxoSmithKline, Alliance
Pharmaceuticals, Pharma Natura, GNLD and Azochem Laboratories. He has worked in South Africa, East
and West Africa, Europe and America; and firmly believes that the South African manufacturing industry
is capable of matching those in first world environments. Wayne has been Operations Director at a
leading CAMS Manufacturer and Packer, Azochem Laboratories, since 2009 and is now the Sales and
Technical Director dealing directly with clients, product development and regulatory issues.
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.