Lecture 24 - GMP Flashcards
(11 cards)
What is Good Manufacturing Practice (GMP)?
A system of regulations and guidelines to ensure pharmaceutical and natural products are produced consistently and controlled to meet quality, safety, and efficacy standards appropriate for their intended use.
Enforced by regulatory agencies such as FDA, EMA, and WHO. Covers all aspects of production including raw materials, facility hygiene, staff training, equipment maintenance, and documentation.
Which regulatory bodies enforce GMP globally?
- FDA (USA)
- EMA (Europe)
- WHO
- New Zealand’s Medsafe
Each body oversees compliance for medicines, food, and dietary supplements in their respective regions.
How are Dietary Supplements regulated in New Zealand?
Under the Dietary Supplements Regulations 1985, covering products mainly used as food supplements without therapeutic claims.
These supplements cannot make therapeutic claims.
What governs Natural Health Products (NHPs) in New Zealand?
They fall under the Medicines Act 1981, especially when therapeutic claims are made or they contain active medicinal ingredients.
This regulation ensures safety and efficacy for products making therapeutic claims.
What is the purpose of the Natural Health Products Bill in New Zealand?
- Ensure natural health products are safe and effective
- Maintain a database of allowable/unallowable ingredients
- Prescribe labelling requirements
- Require registration for all NHPs
- Set manufacturing standards
- Enforce product recalls
- License manufacturers
- Conduct safety assessments
The bill aims to provide a comprehensive regulatory framework for NHPs.
What are the regulatory requirements for registering Natural Health Products in New Zealand?
- Labelling compliance with ingredient listing and usage instructions
- Manufacturer licensing confirming GMP compliance
- Safety assessment of ingredients
- Notification/registration with regulatory authority before sale
These requirements ensure consumer safety and product integrity.
What classification do products making therapeutic claims fall under?
Classified as medicines, requiring stringent regulatory requirements including GMP compliance and Medsafe approval.
Examples of therapeutic claims include ‘reduces inflammation’ or ‘treats colds’.
What is the distinction between therapeutic and non-therapeutic claims?
- Therapeutic claims: Subject to strict regulations and classified as medicines
- Non-therapeutic claims: Less regulated but must be truthful and not misleading
Non-therapeutic claims can include statements like ‘supports general wellness’.
What cultural and legal considerations are involved in natural product regulation in New Zealand?
- Protection of Toanga rākau (treasured plants) and Māori traditional knowledge
- Wai 262 claim regarding Māori rights over indigenous flora and fauna
- Requirement for consultation with Māori to protect cultural heritage
These considerations ensure equitable sharing of benefits and respect for indigenous knowledge.
What is the overall regulatory stance on natural products in New Zealand?
Natural products are generally regulated as foods unless they make therapeutic claims, which require regulation as medicines under Medsafe.
The Natural Health Products Bill aims to strengthen safety and quality requirements.
True or False: Non-therapeutic claims are regulated as strictly as therapeutic claims.
False. Non-therapeutic claims are less regulated but must still be truthful and not misleading.
