What is Good Manufacturing Practice (GMP)?
What is Good Manufacturing Practice (GMP)?
Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, help ensure therapeutic goods are of high quality. The TGA defines GMP as a framework that covers the "production, testing, and release" of medicines to maintain consistent quality and safety standards.
GMP is not a voluntary guideline — it is a regulatory requirement enforced by the Therapeutic Goods Administration (TGA). Manufacturers of listed medicines must either hold a TGA manufacturing licence or demonstrate GMP compliance through recognised overseas clearance.
Key GMP Requirements for Listed Medicines
The following are core GMP requirements that apply to listed medicines in Australia:
Manufacturers of listed medicines must hold a TGA-issued manufacturing licence or have GMP clearance from the TGA for overseas manufacturing sites. This licence confirms that the manufacturing facility meets the required quality standards.
📄 Manufacturing for listed medicines — TGA
GMP requires quality control procedures at every stage of production — from sourcing and testing raw materials to in-process checks, final product testing and batch release. This ensures each batch meets defined quality specifications.
📄 Good Manufacturing Practice (GMP) — TGA
The TGA conducts inspections of manufacturing sites to verify GMP compliance. These inspections assess facilities, equipment, processes, documentation and quality management systems. Non-compliance can result in regulatory action.
📄 Manufacturing — Inspections — TGA
GMP requires comprehensive documentation of all manufacturing processes, raw material sourcing, testing results and distribution records. This ensures full traceability of every batch from production through to the consumer.
📄 Good Manufacturing Practice (GMP) — TGA
What GMP Means for LDV20
As a TGA Listed Medicine (AUST L 502251), LDV20 is manufactured in accordance with GMP standards. This means:
- The manufacturing facility operates under a TGA manufacturing licence or recognised GMP clearance.
- Raw materials — including policosanol (sugar cane wax alcohols), berberine (Berberis aristata), silymarin (Silybum marianum) and chromium (chromic chloride hexahydrate) — are sourced and tested in accordance with GMP specifications.
- Each batch of LDV20 undergoes quality control checks during and after production.
- Complete documentation and traceability records are maintained for every batch.
For full product details, see the official LDV20 product page.
Frequently Asked Questions
What does GMP stand for?
GMP stands for Good Manufacturing Practice. It is a set of principles and procedures that ensure therapeutic goods, including listed medicines, are manufactured to consistent quality standards as required by the TGA.
Is GMP mandatory for listed medicines in Australia?
Yes. The TGA states that "unless exempt, listed medicines must be manufactured in accordance with recognised Good Manufacturing Practice (GMP) standards." This is a regulatory requirement, not a voluntary guideline.
Does the TGA inspect manufacturing facilities?
Yes. The TGA conducts inspections of manufacturing sites to verify GMP compliance. These inspections assess facilities, equipment, processes, documentation and quality management systems.
How does GMP differ from general food manufacturing standards?
GMP for therapeutic goods — including listed medicines — is regulated by the TGA and involves stricter quality control, documentation, traceability and inspection requirements than general food manufacturing standards. Medicines manufactured under GMP are subject to regulatory oversight specific to therapeutic goods.
References
- Therapeutic Goods Administration. Manufacturing for listed medicines. — TGA — Manufacturing
- Therapeutic Goods Administration. Good Manufacturing Practice (GMP). — TGA — GMP
- Therapeutic Goods Administration. Listed medicines. — TGA — Listed medicines
- Therapeutic Goods Administration. Understanding listed and registered complementary medicine regulation. — TGA — Regulation guidance
- Therapeutic Goods Administration. ARTG listing — AUST L 502251. — TGA ARTG 502251
Last updated: April 2026 | Prepared by: Pure Australia Editorial Team
Always read the label and follow the directions for use.