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PR3145 (pharm law) > Lecture 3 THMP > Flashcards

Lecture 3 THMP Flashcards

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1
Q

definition of THMP

A
  • herbal or traditional medicine is a medical product, not a food or dietary supplement or cosmetic product
  • contains 1 or more herbal substance as active ingredients
  • active ingredients are not synthetic
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2
Q

what are not considered THMP

A
  1. drug products (chemically synthesised)
  2. biologicals and biotech derived medicinal products
  3. food, dietary, nutritional supplement
  4. cosmetic products
  5. medical devices
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3
Q

ICH product quality guidelines

A
  1. product quality and performance can be improved by focusing upstream on pharmaceutical development (Quality of design)
  2. regulators and manu recognise capability of sci and tec (eg. PAT, QBD to improve quality)
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4
Q

current regulatory status for THMP

A
  1. lack of harmonised GMP standards for THMP
  2. minimal product qualityu requirements
    - limits of micro organiusm in finished THMP
    - limits of toxic heavy metals in finished THMP
  3. product quality attributes which are not mandatory
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5
Q

whart are product quality that are not mandatory for THMP

A
  • control of herbal active ingredients (identification and assay)
  • control of other starting material (water, preservatives, excipients)
  • control of container-closure systems
  • stability (shelf life) testing and process validation
  • control of herbaL contaminants (pesticides, fumigants)
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6
Q

challenges in regulating THMP

A
  1. harmonisation of GMP standard for THMP
  2. harmonisation of quality standard for THMP
  3. combating adulterated THMP
  4. leveling up of cottage THMP industry
  5. implementation of GACP
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7
Q

harmonisation of GMP standard for THMP

A

52 PIC/S participating authorities with effect from 1/1/18 including
1. EU members
2. australia, NZ, canada, USA
3. SG, MY, Indo, Thai, KR, Jap, TW, HK
4. argentina, South africa
and more authorities are applying to join PIC/s, making it a good starting point for global harmonisation of GMP s standard

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8
Q

harmonisation of quality standard for THMP

A

safety and efficacy may be indirectly inferred from historical use, while quality might be independent
- if herbs are processed, packed and presented as pharmaceutical dosage forms, then established quality requirements for pharmaceutical products should apply to THMPs

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9
Q

contents of EMA document

A
  1. QC of herbal active ingredient
  2. QC of other starting material (including water)
  3. control of container-closure systems
  4. stability (shelf life) testing
  5. control of herbal contaminants, including pesticides, fumigants, heavy metals, microbial limits
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10
Q

why control of water quality is important

A
  1. main starting material in oral liquid THMP has to meet pharmaceutical quality standard
  2. quality of feed water is variable depending on source of water, and seasonal variation
  3. contains chemical and mineral impurities which affects stability profile and quality of THMP in liquid dosage forms
  4. contains microbiological impurities: good potential medium for microbial growth will affect product stability or quality and pose health risk
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11
Q

properties in water we need to compare

A
  1. pH
  2. heavy metals
  3. total organic carbon TOC
  4. Oxidisable substance
  5. Conductivity
  6. microbial limit
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12
Q

profile of manu of adulterate THMP

A
  • unscrupulous manu in backyard facilities with improper equipment
  • with deliberate intent to cheat (criminal in nature)
  • cause acute toxicity to patients
  • adulterants often present in large amounts
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13
Q

suspected adulterants for slimming

A
  1. fenfluramine
  2. thyroxine
  3. sibutramine and analogues
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14
Q

suspected adulterants for baldness

A
  1. minoxidil
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15
Q

suspected adulterants for arthritis

A
  1. steroids

2. NSAIDs

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16
Q

suspected adulterants for fever, cold, flu, typhoid

A
  1. paracet
  2. aminopyrine
  3. chlorpheniramine
17
Q

suspected adulterants for epilepsy

A

phenytoin

18
Q

suspected adulterants for erectile dysfunction

A
  1. sildenafil

2. tadalafil and analogues

19
Q

what are analogues

A

synthesised drugs to circumvent drug laws, usually attachment of additional atoms, side chains or other functional group

20
Q

combating adulterated THMP

A
  1. educating consumers and public
  2. increased industry vigilance
  3. exchange of info and alerts amongst regulators (internationally)
  4. sharing of test methods and reference standards for testing adulterants, including new analogues
  5. inspectors: robust GMP/GDP audit and tight chain control
21
Q

leveling up the THMP industry

A

balancing interest of stakeholders

  1. fast market access: public safety/quality issues
  2. trade commercial interest: societal interest
  3. national considerations: globalisation and harmonisation
  4. THMP regulation: pharmaceutical regulation

PR3145 (pharm law) (6 decks)

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