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PR3145 > Lecture 3 Assuring Quality of THMP > Flashcards

Lecture 3 Assuring Quality of THMP Flashcards

1
Q

Are pharmaceutical products made from herbal plants (i.e. Vinblastine, morphine, atropine etc..) considered THMPs?

A

No, they are considered pharmaceuticals

any herbal material that has been converted to tablets, capsules, injections, syrups –> becomes a pharmaceutical dosage form

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2
Q

Why is there a need to define THMPs and Harmonize standards?

A
  • there are multiple terminologies (e.g. Trad Med in Europe by CHP in sg)
  • multiple national and international GMP standards
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3
Q

What are some general agreements on THMP (herbal medicine and traditional medicine) definition?
What is the definition of Herbal Medicine and Traditional Medicine?

A

Herbal Medicine

  • A herbal medicine is a medicinal product
  • Not considered food, supplement or cosmetic product
  • Contains 1 or more Herbal substances as active ingredients
  • Active ingredients are not synthetic but herbal in nature

Trad Med

  • A herbal medicine is a medicinal product
  • Not considered food, supplement or cosmetic product
  • Contains 1 or more ‘traditional’ substances as active ingredients (e.g. herbal, mineral or animal origin)
  • Active ingredients are not synthetic

For both:
their inert ingredients may be synthetic

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4
Q

What is the main difference between Traditional medicine and Herbal medicine?

A

Traditional substances include those of herbal, animal or mineral origin
- Everything else that applies to Herbal medicines also apply to traditional medicines

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5
Q

What products are not considered as THMPs?

A
  • Drug Products (Chemically Synthesized)
  • Biologicals and Biotechology- Derived Medicinal Products (ctgt)
  • Food, Dietary or Nutritional Supplements
  • Cosmetic Products
  • Medical Devices
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6
Q

What is the current regulatory status of THMPs?

A
  • Lack of harmonized GMP standard
  • Minimal product quality requirements (only limits on microbial content and toxic heavy metals)
  • Product Quality Attributes which are not mandatory (control of herbal active ingredients and other starting materials, control of container-closure systems, stability testing & process validation, control of other herbal contaminants - pesticides and fumigants)
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7
Q

What are the challenges and issues in regulating THMPs?

A
  1. Harmonization of GMP Standard for T/HMP
  2. Harmonization of Quality Standard for T/HMP
  3. Levelling Up of (Cottage) T/HMP Industry
  4. Combating Adulterated T/HMP
  5. Implementation of GACP (Good Agricultural and Collection Practice)
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8
Q

What is the most common category of health products that are adulterated?

A

THMPs

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9
Q

What is a good starting point for harmonization of GMP standard for THMPs?

A

PICS GMP standard Annex 7 covers herbal medicinal products

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10
Q

Does historical use guarantee the safety, efficacy and quality of the THMPs?

A

Safety and efficacy can be indirectly inferred from historical use
- Quality is independent of Traditional or Historical use

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11
Q

What is a good starting point for harmonizing quality for THMPs?

A

EMA (European Medicines Agency) guidance note on quality of herbal medicinal products

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12
Q

What are the contents of the EMA guidance note on quality of herbal medicinal products?

A
  • QC of herbal active ingredients and other starting materials (including water)
  • Control of container closure systems
  • Stability testing
  • Control of herbal contaminants (pesticides, fumigants, heavy metals and microbial limits)
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13
Q

Why is control of water quality important?

A
  • Water is the main starting material in oral (liquid) THMPs
  • Quality of feed water is variable (depending on source and season)
  • Water can contain microbiological (microbial growth possible), chemical and mineral impurities which may affect the product stability/quality in liquid dosage forms and poses health risks
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14
Q

Why can’t potable tap water be used in manufacturing THMPs?

A
  • Disinfection with chlorine (can affect stability and quality of dosage form) - CL is a strong chemical and oxidising agent
  • Distribution via long (old) pipes
  • Less stringent and defined compared to BP standards
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15
Q

What’s are the 6 differences in definitions between BP purified water and potable water?

A
  • pH
  • Heavy metals
  • Total Organic Carbon (TOC)
  • Oxidizable substances
  • Conductivity
  • Microbial limit
    All 6 are more stringent and defined for BP purified water
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16
Q

Why are adulterated THMPs dangerous?

A
  • Often appears good, sleek and elegant
  • Often made by unscrupulous manufacturers
  • Can cause acute toxicity
  • Adulterants often present in large amounts
17
Q

What type of THMP products are commonly adulterated?

A
  • Weight loss/ slimming
  • Erectile dysfunction and decreased libido
  • baldness
  • fever, cold, flu, typhoid
  • arthritis
  • epilepsy
18
Q

What is the suspected adulterant when the claim is ‘slimming’ ?

A

Fenfluramine , Thyroxine, Sibutramine and Analogues

19
Q

What is the suspected adulterant when the claim is ‘baldness’ ?

A

Minoxidil

20
Q

What is the suspected adulterant when the claim is ‘arthritis’ ?

A

Steroids, NSAIDs

21
Q

What is the suspected adulterant when the claim is ‘fever, cold, flu, typhoid’ ?

A

Paracetamol, Aminopyrine, Chlorpheniramine

22
Q

What is the suspected adulterant when the THMP indication is ‘epilepsy’ ?

A

Phenytoin

23
Q

What is the suspected adulterant when the THMP claim is for ‘erectile dysfunction, libido’ ?

A

Sildenafil, Tadalafil and Analogues

24
Q

How do unscrupulous manufacturers avoid detection of adulterants?

A
  • Adulteration using analogues

- Hiding adulterants in capsule shells

25
Q

What are analogues?

A

Analogues (aka Designer Drugs) are synthesized to circumvent drug laws
Via attachment of additional atoms, side chains and other functional groups

According to US DEA CSA; “any substance whose chemical structure is substantially similar to that of ___”

26
Q

What is the foreign law that SG authorities took reference for combating analogues?

A

US DEA controlled substances act (CSA) with similar statements in SG poisons act/misuse of drugs act

27
Q

What are some strategies in combating adulterated THMPs?

A
  • Educating consumers and public
  • Increased industry vigilance
  • Exchange of info and alerts amongst regulators (internationally)
  • Sharing of Test Methods and Reference Standards for Testing Adulterants, including New Analogues
  • Inspectors: Robust GMP/GDP Audit and Tight Supply Chain Control
28
Q

How can tight supply chain control be implemented?

A

GMP compliance needs to be implemented in:
- Overseas/locally manufactured THMPs

GDP compliance in:

  • Storage
  • Distribution
  • Retailers (pharmacies and drug stores)
29
Q

What are the interests that the regulators need to balance for THMP stakeholders?

A
  1. Fast Market Access vs Public Safety/Quality Issues
  2. Trade/commercial interests vs Societal interests
  3. National Considerations vs Globalization and Harmonization
  4. THMP regulation vs Pharamceutical regulation
30
Q

What is the HSA’s stand on THMPs?

A

Buyers Beware, Regulators Beware

- label on THMPs to remind consumers that discretion is advised

31
Q

What are some established standards for pharmaceutical products that is not implemented for THMP yet?

A
  • PIC/S GMP standards (parts I and II, and their annexes)
  • ICH product quality guidelines (incl Q8, Q9, Q10)
  • -> QbD (pdt quality & performance improved by focusing upstream)
  • -> and improve qly through science & tech e.g. PAT, QBD

PR3145 (10 decks)

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