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PE009-13, the PIC/S guide to GMP for medicinal products
TGA interpretation and expectations for demonstrating compliance
Herbal medicinal products (Annex 7)
If an active or marker compound is identified and no commercially available primary standard is available, a suitably controlled and characterised reference material of that compound should be obtained from external sources.
Quantified by input
Please refer to the ARGCM Part B: Listed complementary medicines for guidance on use of the term ‘quantified by input’ for listed complementary medicines.
Good Agricultural and Collection Practices (GACP)
Statements within this annex relating to Good Agricultural and Collection Practice are not mandatory. Alternative methods of assuring the suitability and quality of herbal starting materials are permissible. It is recommended that GACP practices are considered during supplier qualification, as GACP may assist in influencing routine sampling and testing programs for herbal starting materials.
The recommendations regarding Good Agricultural and Collection Practice apply to manufacturers involved in the cultivation of herbal starting materials (herbs) only.
Adulteration or substitution of herbal substances
Manufacturers should assess the range of herbal substances used in order to determine whether specific herbal substance is at risk of adulteration or substitution. Potential risk factors include:
- materials with high intrinsic value that may be substituted or ‘bulked-out’ with other materials, i.e. cheap plant material, fillers
- highly active compounds including Schedule 8 medicines
- ingredients for use in listed medicines that may be adulterated with medicinal substances included in schedules 3, 4 and 8 of the Poisons Standard, e.g. steroids, diuretics, stimulants or medicines used in the treatment of erectile dysfunction
- herbal materials that are difficult to distinguish microscopically, e.g. milled or powdered materials and plant parts that have very similar microscopic appearance
- materials from new sources especially in circumstances where the reputation of reliability of the supplier is not known
- large offers of herbal materials that are generally only available in limited quantities
- out-of-range prices for materials
The justification and application of additional testing should follow basic risk management principles.
Identification of herbal materials
The TGA has published guidance regarding the requirements for identification of herbal materials.
Samples of unmilled plants
Manufacturers performing the identity testing of herbal materials are required to hold appropriate certified reference samples for the herbal materials used. Reference samples should be traceable back to a suitable primary reference material. Where powdered materials are used in the manufacture of an API or product, the manufacturer performing the testing is expected to hold an appropriate certified reference material of unmilled plant. This is due to the inherent difficulties and risks associated with the identification of powdered plants.