Assuring Quality of THMP Flashcards
Name some definitions of T/HMP according to WHO, PIC/S & EU Directives
- Herbal medicine is a medicinal product
- It is NOT food or dietary supplement or cosmetic product
- Contains >1 Herbal substances as API
- API are NOT synthetic (but excipients can be)
Are nutritional supplements T/HMP?
No
Compared to pharmaceutical products, do T/HMP products have a more established standards?
No, it lacks Harmonised GMP Standards
What are the minimal product quality requirements of a T/HMP?
- Micro-organism limits
2. Toxic heavy metals (Hg, As, Pb, Cu)
Name some product quality attributes of T/HMP that are NOT mandatory
- Control of herbal active ingredients (E.g. ID and assasy)
- Control of starting materials
- Control of container-closure systems
- Stability testing and Process Validation
- Control of Herbal Contaminants (such as pesticides & fumigants)
Name some challenges and issues in regulating T/HMPs
- Harmonisation of GMP standards
- Harmonisation of Quality Standard
- Combating Adulterated T/HMP
- Improving the T/HMP industry
- Implementation of GACP (Good Agricultural & collection practice)
Person X says “Since herb J is used for a very long time, it must be of high quality.”
Do you agree with person X? Explain your answer
Disagree
- Quality is independent of traditional or historical use
- Herbal materials are processed and presented as pharm dosage forms, hence established quality requirements for products should also apply to T/HMP
- Some example of established quality includes: Dissolution time of the product, hardness of tabs, etc.
The contents of the Document of Europeans’ Medicines Agency (EMA) consists of several chapters. One of them is “QC of other starting materials including water”.
Name some reasons why Water quality is important
- Main starting material in PO liquid T/HMP
- Quality of Feed Water is variable (E.g. sources, season)
- May contain Chemical and Mineral Impurities which affect T/HMP stability profile
- Contain Microbiological Impurities which affect stability as well as Health Risks
Why can we NOT use potable water in place of purified water (specified by BP)?
Tap water has many different properties and toxicities
E.g.
- Tap water is distributed via Long Distribution Pipes (which may get contaminated along the way)
- Tap water is disinfected with Chlorine, which is a strong oxidising agent
What is a common property of an adulterated T/HMP product?
They look good, sleek and elegant. They are usually explicitly attractive (e.g. using movie stars’ picture in the packaging)
Two common ways in which unscrupulous manufacturers use to avoid detection of adulterants
- Adulterated ingredients used in making capsule shells
2. Using analogues of the known ingredient
Name a few ways to combat adulterated T/HMP
- Educate consumers and public
- Increase industry vigilance
- Exchange information amongst Regulators internationally
- Sharing new test methods and reference standards fro adulterants and their new analogues
- Inspectors have to carry out robust GMP/GDP audit and tight supply chain control
Name some considerations in balancing interests of stakeholders?
- Fast market access VS Public safety/Quality issues
- Trade/Commercial Interests VS Societal Interests
- National Considerations VS Globalisation and Harmonisation
- T/HMP Regs VS Pharm regs
Differences between potable water and purified water
- Heavy metal levels are unknown in potable water but <0.1 ppm in purified water
- Conductivity of potable water is 250-500 while in purified water it is <4.3 at 25 deg cel
- Total organic carbon and oxidisable substance levels are unknown in potable water but total organic carbon levels in purified water is <500
- Microbial limits in purified water is more stringent
What is Slim 10 adulterated with
nitroso-fenfluramine
