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Compliance & GMP > L3 > Flashcards

L3 Flashcards

1
Q

What is the definition of a Herbal Medicine?

A

A herbal medicine is a MEDICINAL product.

  • Not food or dietary supplement or cosmetic product.
  • Contains one or more HERBAL substances as active ingredient.
  • Excipients can be synthetic.
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2
Q

What is the definition of a Traditional Medicine?

A

A traditional medicine is a MEDICINAL product.

  • Not food or dietary supplement or cosmetic product.
  • Contains one or more “TRADITIONAL” substances as active ingredient. This includes Herbal, Mineral & Animal origin.
  • Excipients can be synthetic.
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3
Q

What does “traditional” substances include?

A
  1. Herbal substances
  2. Mineral substances
  3. Animal originated substances
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4
Q

All of the ingredients contained in a Herbal Medicinal product must NOT be synthetic.
T/F?

A

False.

The active ingredients are not synthetic, but the excipients and inert substances can be synthetic!

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5
Q

A Herbal medicine is a Traditional Medicine.

T/F?

A

True

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6
Q

A Traditional Medicine is a Herbal Medicine.

T/F?

A

False

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7
Q

What are the minimal product quality requirements for T/HMP?

A
  1. Limits of microorganisms

2. Limits of toxic heavy metals

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8
Q

What are the 5 key challenges in regulating T/HMP?

A

The need for:

  1. Harmonization of GMP Standard for T/HMP
  2. Harmonization of Quality Standard for T/HMP
  3. Combating Adulterated T/HMP
  4. Levelling up of T/HMP Industry
  5. Implementation of GACP (Good Agricultural & Collection Practice)
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9
Q

Between the need for harmonization of GMP Standard versus Harmonization of Quality Standard of T/HMP, which is more challenging?

A

Harmonization of Quality Standard

GMP -> We alr have an annex under PIC/S GMP
(Chapter 4, Annex 11)

However, the EMA Guidance Note on Quality of Herbal Medicinal Products can provide a good starting basis for the Harmonization of Quality Standards

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10
Q

In combating adulterated T/HMP, what is the main strategy?

A

Buys beware, Regulators beware

Multi-prong strategies

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11
Q

What is a reason why adulterated T/HMP are hard to detect?

A

Manufacturers use analogues instead of the actual adulterant in their products :(

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12
Q

What is a good starting point for Harmonization of Quality Standards for T/HMP?

A

EMA Guidance Note on Quality of Herbal Medicinal Products - contains details on QC of Herbal Active Ingredients, other starting materials INCLUDING WATER, control of container closure systems, stability testing, heavy metals and microbial limits etc.

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13
Q

Name 5 strategies to combat Adulterated T/HMP?

A

==> Buyers and Regulators Beware

  1. Consumer/public education
  2. Industry Vigilance
  3. Exchange of Information among regulators internationally
  4. Sharing of Test Methods and Reference Standards
  5. Inspectors: Robust GMP/GDP (Good Documentation Practice) Audit + Tight Supply Chain control for BOTH local and international suppliers
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14
Q

Why is Water Quality important and also regulated?

A
  1. It is a main starting material in liquid preparations
  2. Quality of Feed Water can vary depending on source and seasonal variations (Feed water: Rivers, Wells etc NOT PREFERRED)
  3. Contains Chemical/Mineral Impurities - affects quality
  4. Contains microbiological impurities
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15
Q

Name some suspected adulterants for slimming products

A

Fenfluramine, Thyroxine, Sibutramine & Analogues (e.g. Nitroso-fenfluramine in Slim10)
=> All synthetic, not traditional

Note: Fenfluramine and Sibutramine are Appetite Suppressants
Thyroxine increases metabolic rate of the body.

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16
Q

Name some suspected adulterants for Balding products

A

Minoxidil

=> Synthetic

17
Q

Name some suspected adulterants for Arthritis products

A

Steroids (e.g. Dexamethasone), NSAIDs

18
Q

Name some suspected adulterants for Fever, Cold, Flu, Typhoid products

A

Paracetamol, Aminopyrine, Chlorpheniramine

=> Synthetics

19
Q

Name some suspected adulterants for Erectile Dysfunction/Decreased Libido products

A

Sildenafil, Tadalafil and Analogues
=> All synthetic ED drug compounds

May also sometimes include anti-diabetic agents (E.g. Gilbenclamide), but those ingredients may also be accidentally incorporated by clandestine laboratories

Note: Tongkat Ali is the natural herbal/traditional substance believed to help in ED/low libido, allowed

20
Q

Name some suspected adulterants for Epilepsy products

A

Phenytoin (Synthetic)

21
Q

What does levelling up T/HMP entail?

What needs to be considered when levelling up the T/HMP industry?

A

Balancing interests of stakeholders

  1. Fast market access vs Public Safety/Quality Issues
  2. Commercial interests vs societal interests
  3. National considerations vs Globalization/Harmonization (e.g. Jamu is indigenious to Indonesia, political consequences of imposing strict compliance on the Jamu Medicinal Industry)
  4. T/HMP Regulation vs Pharmaceutical Regulation
22
Q

There are not alot of quality requirements for T/HMP, but name two requirements required for T/HMP products to meet

A

Limits for Microorganisms and Toxic Heavy Metals

Compliance & GMP (7 decks)

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