GMP – what, why, how ….
Comparison – GMP/FDA
Vision Products – the REAL quality.
Vision Quality USP – the talking points
What is Quality:“Degree to which a set of inherent characteristics fulfil requirements” (As per ISO 9001:2008) •It must have customer focused. How well the needs of the customer are satisfied. •It can mean different things to different people •It is related to price. •It does not only means goodness, elegance Care in selection of products & company is necessary.
So it is very important to recognise & choose: â€˘The correct product and â€˘The correct company Question is HOW?
GMP – what, why, how ….
If you have choice, where you like to eat?
â€˘ You do not even need to think. â€˘ Because we do not want to take chances with something we eat. BUT QUALITY IS SUBJECTIVE.
To reduce subjectivity, governments established a series of laws that regulate production of what we eat or use to ensure that safe products are made & protect consumers. These guidelines are called good manufacturing practises or GMP
What is GMP – good manufacturing practice? GMP is part of the quality system that can impact the quality of a product & which covers the: • Production & • Testing of products A basic tenet of GMP is that quality cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process.
Ten Principles of GMP 1. Write step by step operating procedures and work on instructions 2. Follow written procedures and instructions 3. Document work for compliance & traceability 4. Validate work (systems do what they are designed to do) 5. Design and construct the facilities and equipments properly 6. Monitor &maintain facilities and equipment 7. Design, develop and demonstrate job competence 8. Protect against contamination 9. Build quality into products by systematic control of components & processes as manufacture, packaging, labelling etc. 10. Conduct planned and periodic audits
Certifying agencies • ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharma for Human Use) • WHO (World Health Organisation) Many countries have created their own GMP guidelines that correspond with their legislation : • EU: European Medicines Agency + individual country control bodies. • USA: US FDA (Food & Drug Administration)
Part 3: Comparison – GMP/FDA
EU GMP and US FDA GMP
Quality Standards Level FOOD FOOD
FOOD FOOD SUPPLEMENTS SUPPLEMENTS
ISO 22000 22000 for for ISO Food Supplements Supplements Food
EU GMP GMP for for EU pharmaceuticals pharmaceuticals
GMP* for for GMP* Food Supplements Supplements Food
US FDA FDA GMP GMP for for US pharmaceuticals pharmaceuticals
* Not same as pharma, now being implemented
OUR MANUFACTURING STANDARDS • First laboratory to be ISO 22000 certified for food supplements. • Linked to USA food supplement GMP standards.
• EU Pharma GMP • Certified by AFSSAPS (French Health Products
Safety Agency), which issues the GMP in France.
Pharma GMP of EU & USA are comparable. BUT European GMPs have additional 3 important chapters: Chapter 7: Contract manufacture and analysis specifying a compulsory manufacturing contract + specifications Chapter 8: Complaint and product recall ďƒ¨ compulsory guidelines Chapter 9: Self inspection ďƒ¨ internal audit guidelines plus EU GMPs have supplemental 18 appendices.
cGMP ? “cGMP” – where c = current, to emphasize that the most latest regulations are being followed.
Part 4: Vision quality.
Be confident with the REAL GMP STANDARD.
Worldwide Supply Chain
• Over 600 plant species bought from all over the world • Over 700 tons of dry plants bought per year • Raw material comes in all forms: roots, seeds, leaves, fruits…..
Sea buckthorn fruit
Siberian ginseng (Chromevital)
Witch-Hazel (Nutrimax) Kola (Chromevital)
Lemon balm & Lavender (Pax+Forte) Fucus (Sveltform)
Catâ€™s claw (Detox) Guarana (Chromevital)
Plants from more that 40 countries
Green Tea (Sveltform)
Vision - QUALITY FIRST • GMP: 55 employees only for the quality control lab • Sampling & analysis at every production step: 19 employees • Ecocert certification for organic products
Plant Reception Plant Supplying
•Mixture •Quality Testing •Quality
•Capsule •production •Quality
•Packing Bottle •Quality
•Shipment to •Warehouse
EXCLUSIVE: HIGH TECHNOLOGY PROCESS Cryo Grinding (also called Freeze Grinding): A high technology manufacturing technique: Plant grinding at low temperatures using liquid nitrogen at -196°C Advantages ? 1.Protects the plants integrity 2.No degradation (due to heating / oxidation during process) 3.Optimises the active ingredients bio-availability.
•Exclusive for Vision products. •Only company to use this technology for food supplements
Only GMP is not enough. Vision follows it up with GDP. GDP: good distribution practice 1.Quality maintained throughout the distribution network, with no alteration of product properties. 2.Storage conditions are observed at all times, including during transportation; 3.Contamination from or of other products is avoided; 4.Tracing system to find any faulty product 5.Recall procedure.
Quality is to be maintained throughout the system. It has to be everywhere – ingredients, manufacturing processes, packing, delivery…. It has to be shared by every function and department. -Company’s values, vision & mission statement -Products & Services -Internal & external management processes -Marketing brochures, logo & stationery -Product packing -Offices, shops etc….
Logo: “a picture is worth a thousand words”
Part 5: Vision Quality USP â€“ the selling & talking points
Summary ASK 7 QUESTIONS WITH PRIDE: 1. Vision products are GMP certified. 2. GMP is not for food or food supplements, but PHARMA grade, the toughest standard to obtain.
3. Pharma GMP status certified by French & Irish authority. Compares with FDA GMP, with extra advantages.
4. First laboratory to obtain ISO 22000 certification. 5. ONLY laboratory to use high tech: CRYO Grinding process for food supplement products.
6. Distribution by GDP system to maintain quality. 7. Recognised & cooperating with WHO