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With the growth of the health product industry, expansion of product ranges and mass production of nutritional supplements, ensuring product quality and safety to the consumer is of great importance. Implementation and monitoring of internationally recognised manufacturing standards are therefore vital to ensure safe, effective and quality nutritional products.
The Importance of Good Manufacturing Procedures and Standards
Manufacturing standards are implemented within the nutritional supplement industry for quality assurance purposes and to ensure the safety and efficacy of nutritional products.
GOOD MANUFACTURING PRACTICE (GMP)
What is GMP?
GMP is set of guidelines for the manufacturing of pharmaceutical products which is applied internationally.
GMP is concerned with:
- production standards
- quality control
- public safety
Monitoring of GMP Compliance
Compliance to GMP is audited by the relevant medicines regulatory authorities, for instance:
- South Africa: Medicines Control Council (MCC)
- Australia: Therapeutic Goods Administration (TGA)
- United States: Food & Drug Administration (FDA)
- United Kingdom: Medicine and Healthcare Products Regulatory agency (MHRA)
- Europe: European Medicine Evaluation Agency (EMEA)
GMP Compliance Requirements:
Published GMP regulations and guidelines have a significant impact on the daily operation of a production facility.
GMP covers amongst other aspects:
- Sourcing of the finest quality raw materials
- Quality control (QC) testing and approval at all stages of production:
- Testing of raw materials to comply with safety and quality specifications
- Inspecting and testing of starting materials and packaging materials
- Testing of product composition: in-process and post production to ensure label claim compliance
- Utilising approved testing procedures
- Validation of test methods
- Validation of equipment and processes
- Records:
- Records must enable full traceability of ingredients and packaging materials used in all batches of a product
- Records must be kept of all testing procedures
- Recording and investigation of any deviations
- Retention Samples for future examination:
- Sufficient reference samples of all batches of starting materials and end products should be retained
- Monitoring of the manufacturing environment
- Training of personnel
- Release of a product for sale only after certification by an authorised person
FREQUENTLY ASKED QUESTIONS
Did you know? All Natrodale products are manufactured according to stringent international pharmaceutical GMP standards. Natrodale’s pharmaceutical manufacturing plants are certified by the South African MCC and the Australian TGA and therefore comply with both local and international manufacturing standards.
Does Natrodale comply with International Manufacturing Standards?
Natrodale’s factory is recognised as an international Pharmaceutical Manufacturer through its registration with the Australian Therapeutic Goods Association (TGA). The TGA is a participating authority in the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).
How does Natrodale ensure compliance to product label claims (levels of nutrients)?
- Raw materials are only accepted if accompanied by a batch specific certificate of analysis. The contents of every batch of raw material is verified and tested by Natrodale’s laboratory.
- All products are tested during the course of the manufacturing procedure.
- On completion of manufacture, products are only released for sale if all test criteria are met. These tests ensure compliance of the product with nutrient levels claimed on the product’s packaging.
Are the nutrient levels in Natrodale nutritional supplements still in agreement with the product label claims after 2 or 3 years when the product expiry date is reached?
All nutrients levels in Natrodale’s products are required to still meet the label claim on the date of expiry which is printed on the product packaging.
This is ensured by:
- Placing selected batches of all products on stability trials
- Storing products under controlled conditions
- Testing products at regular intervals to confirm stability at end of the shelf life
Which resources are required to ensure Natrodale’s compliance to GMP standards?
- Suitably designed pharmaceutical production facilities
- Trained personnel, using qualified and calibrated equipment to perform validated, documented procedures
Natrodale employs a highly qualified team of pharmacists, pharmacy assistants, chemists, food scientists, engineers, dieticians and food technologists - to name but a few - in order to maintain these high quality standards.
SHELFLIFE GUARANTEE:
Natrodale products are tested to ensure that nutrient levels are at their optimum according to the product label claims, even at the end of the product’s shelf-life.
SAFETY GUARANTEE:
Each batch of every ingredient used in Natrodale supplements is tested to ensure safety to the consumer. As an example, fish and plant oils used in products such as Natrodale Omega 3-6-9 are tested for the presence of pesticides and harmful heavy metals such as mercury and lead, to ensure safe supplements for our consumers.
EVIDENCE BASED FORMULATIONS
Natrodale products are formulated by a highly qualified team of pharmacists, chemists, scientists and dieticians. Product formulations include ingredients of which the health benefits are based on scientific research.
Good Manufacturing Practice (GMP) Standards
All Natrodale products are manufactured according to strict international pharmaceutical good manufacturing practice (GMP) standards. 
Purity Certified
Natrodale Essential Fatty Acids are purity certified and are free from heavy metals (Lead & Mercury) and pesticides.
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