GMP: what does it mean and why is it important?

Insights

11 Jan 2022

GMP

All pharmaceutical products manufactured and distributed in Australia must adhere to principles and procedures that ensure that the goods produced meet a minimum quality standard. This standard is referred to as Good Manufacturing Practices (GMP).

The certification is bestowed by the Therapeutic Goods Administration (TGA) within Australia and is a good indicator of the quality. The TGA will not grant a GMP manufacturing license without a rigorous inspection. During this the company must demonstrate that GMP guidelines are in place and being followed. This is relevant to all aspects of the manufacturing process from their raw materials to the management systems.

A basic concept of GMP compliance as stated by the TGA is that quality must be built into each batch of product during all stages of the manufacturing process. This means that the product cannot only be tested at the end of the manufacturing process, there must be checks and balances throughout to ensure safety. As medicinal cannabis (and the cannabis plant) falls under GMP requirements for medicines, there are additional categories for medical devices.

Responsibilities of a manufacturer within GMP guidelines.

The responsibilities of a manufacturer of therapeutics goods included, but is not limited to:

  • Ensure that all equipment conforms to applicable standards
  • Ensure that those in charge of production have relevant qualifications and control of processes
  • Ensure that all conditions of production are not outside the limitations of their license
  • Ensure that records are kept of materials, tests, studies, and procedures
  • Ensure that records are kept of batch assignments of goods
  • Ensure the TGA is informed of any quality issues
  • Inform the TGA of any changes to manufacturer or manufacturing processes
  • Make personnel, records, and facilities available for inspection by the TGA

Inspections

The key factor of whether the medicines or products are GMP compliant is the inspection of both facilities and the products provided.

Australian based manufacturers of medicines, including medicinal cannabis, are required to hold a license to manufacture. To obtain a license, a manufacturer must demonstrate compliance with the relevant code of GMP. This is usually, but not always, done through an on-site inspection.

Overseas manufacturers of medicines supplied to Australia are also required to meet an acceptable standard of GMP. Medical devices and pharmaceuticals within their own country is controlled by that country’s health authority. An example of this is the Food and Drug Administration (FDA) in the United States.

Most countries have developed slightly different rules and guidelines for medical production. This resulted in the creation of the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (PIC/s). PIC/s have harmonised guidelines so that countries that are members of PIC/s all agree to certain standards of production. Australia is a member of this scheme.

Selling Imported Goods - CBD Oil

It is an offence in Australia to manufacture therapeutic goods for human use without a license or certification. The only exception is if the manufacturer is exempt from this requirement under the Therapeutic Goods Act 1989.

This especially relates to the importation of products that may not reach the standards designated by the TGA or an equivalent regulatory body. There has been an increase in ‘CBD oil’ imports that does not meet the standard for medical cannabis. For more information on this please see our blog post on Buying CBD Oil.

European GMP

Good Manufacturing Practice GMP is also relevant in the manufacturing of medicines in the EU, where Little Green Pharma has on-going operations. Like its Australian counterpart EU GMP describes the minimum standard that a medicines manufacturer must meet throughout the production processes. Most countries in the EU have their own internal health authorities which monitor GMP. The European Medicines Agency (EMA) runs inspections to verify compliance with these standards and aligns GMP at European Union (EU) level.

Most European countries are also members of PIC/s (Pharmaceutical Inspection Co-operation Scheme). This is a scheme that is leading the international development, implementation, and maintenance of GMP standards and quality systems in the field of medicinal products. Member states available here

Medical Cannabis and GMP

Sponsors of medicinal cannabis products must ensure that their products comply with all applicable quality standards. Under the Therapeutic Goods Act 1989 Australian medicines manufacturers are required to obtain a license to manufacture medicinal cannabis products (sometimes referred to as GMP license) unless exempted.

Medicinal cannabis has a favourable side effect profile compared to many other medications and is generally relatively well tolerated by patients. In addition, the risk of severe, adverse events or dependence is low with medicinal cannabis.2

Australia has some of the strictest quality requirements for therapeutic goods globally thanks to the Australian Government’s commitment to providing a safe product to patients. All medical cannabis therapies produced within Australia must satisfy the strict labelling and quality requirements to ensure all products free from pesticides, moulds, bacteria, heavy metals and contaminants.

Little Green Pharma and GMP

All of Little Green Pharma's products are complaint with Good Manufacturing Practises within Australia and the European Union. All Little Green Pharma products are Australian made and conform with Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017.

Little Green Pharma's medical cannabis preparations provide various THC and CBD profiles and are currently available as LGP Classic medicinal cannabis oil and LGP Flower dried cannabis.

These medicinal cannabis oils are manufactured from a whole plant (full spectrum) extract and combined with medium-chain triglyceride (MCT) oil.

For more information on Little Green Pharma product see here


Reference

1. Gable, RS, ‘Comparison of acute lethal toxicity of commonly abused psychoactive substances’, Addiction, Vol. 99, 2004, pp. 686-696.

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