L3 - Assuring quality of THMP Flashcards
Why is there a need to define THMP & harmonise standards?
- multiple terminologies for THMP
- multiple national & international GMP standards
Definition of Herbal Medicine
- Medicinal product
- Contains 1 or more herbal substances as active ingredients
- active ingredients not synthetic
Definition of Traditional Medicine
- Medicinal product
- Contains 1 or more traditional substances as active ingredients (herbal/mineral/animal origin)
- active ingredients not synthetic
What is the current regulatory status of THMP?
Lack of harmonised GMP standard
Minimal product quality requirements
- -> Limits on micro-organisms
- -> Limits on toxic heavy metals (Hg, As, Pb, Cu)
Product quality attributes which are NOT mandatory include:
- -> control of herbal active ingredients & other starting materials
- -> control of container closure systems
- -> stability (shelf-life) testing & process validation
- -> control of herbal contaminants
List the challenges/issues in regulating THMP
1) Harmonisation of GMP standard
2) Harmonisation of quality standard
3) Combating adulterated THMP
4) Levelling up of (cottage) THMP industry
5) Implementation of GACP (not discussed in mod)
Challenges & Strategies in regulating… Harmonisation of GMP standard
PIC/S GMP Standard (annex 7) good starting point
- 53 members, covering 6 continents in the world
- more authorities applying to join
Challenges & Strategies in regulating… Harmonisation of Quality Standards for THMP
Challenges:
- THMP have withstood time, tradition & hx so may be mistaken to safe, efficacious & of good quality???
- BUT quality is independent of traditional/historic use
Strategies:
- EMA guidance on quality of herbal medicinal products is a good starting point to harmonising quality standards
- -> Contents of EMA document:
- QC of herbal active ingredients
- QC of other starting materials including H2O
- Control of container-closure system
- Stability (shelf-life) testing
- Control of herbal contaminants (incl pesticides, fumigants, heavy metals, microbial limits)
Why is control of water important?
1) Main starting material in (oral) liquid THMP
- need to meet pharmaceutical quality standards
2) Quality of feed water is variable depending on…
- source of H2O
- seasonal variations
3) Contains chemical & mineral impurities
- affects stability profile & quality of THMP in liquid dosage forms
4) Contains microbiological impurities
- potential medium for microbial growth
- affect product stability/quality & pose health risks
Why do we need to purify potable (tap) water?
- Distributed via long distribution pipes
- Disinfected with chlorine (strong chemical & oxidising agent)
- Varying properties:
- -> pH
- -> Heavy metals, TOC & Oxidisable substances (Unknown in potable H2O)
- -> Conductivity
- -> Microbial limit
Challenges & Strategies in combating adulterated THMP
Challenges:
- Often made by unscrupulous manufacturers in backyard facilities with improper equipment
- Avoid detection by adultering using analogues
–> Analogues: Synthesised to circumvent drug laws via
attachment of additional atoms, side
chains & other functional groups
- Avoid detection by hiding material in capsule shells
Strategies:
- Educating consumers & public
- Increased industry vigilance
- Exchange of info & alerts among int regulators
- Sharing test methods & ref standards for testing adulterants (& new analogues)
- Inspectors: Robust GMP/GDP audit & tight supply chain
control
How to level up the THMP industry?
Need to balance interest of diff stakeholders!!!
1) Fast market access Public safety/quality issues
2) Trade/commercial interests Societal interests
- do not want to make pdct too $$$ bc of regulatory control
3) Nat considerations Globalisation & harmonisation
- argument that THMP are indigenous to country
4) THMP regulation Pharmaceutical regulation
- t/s whether pharmaceutical regulation should be applicable for THMP products
