GMP Pharmaceuticals Pty Ltd
GMP has over twenty years of experience in servicing the nutritional and health food industry worldwide. GMP Pharmaceuticals has three TGA/GMP licensed factories in Australia and New Zealand with facilities to manufacture a variety of products from soft gel and hard shell capsules, coated to uncoated tablets, powders, liquids, creams and ointments. GMP is the only contract manufacturer in Australia and New Zealand with three TGA/GMP licensed factories. With three factories in two different countries, GMP Pharmaceuticals is able to offer flexibility on “Country of Origin”, delivery time, freight cost, market approach, regulatory compliance and cost.
GMP Pharmaceuticals has the facilities and equipment to pack products in almost any form. Packaging options include bottles, jars, steel cans, vials, blisters (aluminium/aluminium or aluminium/pvdc), tubes and sachets. GMP Pharmaceuticals has close relationships with many major packaging material manufacturers and suppliers worldwide. This extensive packing supplier network allows GMP to meet clients’ specific needs for new and existing products.
Our three TGA and GMP licensed factories also offers more flexibility and cost-saving options for packing product closer to the market, quicker delivery and regulatory compliance.
Working closely with Austrade and the regulatory laws of the lands you wish to export to, GMP can offer assistance with the paperwork required for each country and also advise on what products are allowed in each one and what their particular testing requirements are.
GMP knows and understands how to make products so that they pass each country’s very different regulatory standards.
Most dietary supplement products are classified as complementary medicines in Australia. Products must be registered or listed with the Australian Therapeutic Goods Administration (TGA) before they are introduced into the Australian market. GMP Pharmaceuticals regulatory team has extensive experience assisting clients with all issues related to the registration and listing processes.
Other countries also require listing or registration with their regulatory authority before introducing the product into their markets. GMP Pharmaceuticals has strong regulatory expertise, especially in East Asian countries.
The GMP regulatory team can assist clients in preparing for these processes or GMP can handle the entire process on the client’s behalf.
GMP Pharmaceuticals has research and development laboratories in Australia, New Zealand and China. At these labs, highly qualified and experienced teams are not only familiar with the latest technical and regulatory issues but they also have a deep understanding of market trends, especially in the fast growing East Asian markets. With support from GMP Pharmaceuticals advanced laboratories, GMP staff can set up all documentation including formulations, specifications, testing methods, and stability testing reports. These reports can be used for product registration, listing and product market launches.
Stability testing is now required by most government agencies that regulate complementary medicines and medicinal dietary supplements. Stability testing requires the product to be stored for years so this process is very time consuming.
Stability studies (based on an acceptable potency test) are required to establish the validity of the expiry date that appears on the product package. In order to estimate stability to determine a provisional expiry date, a new product may be subjected to accelerated stability tests, for example incubating at 37°C for 1 week for each year of dating. Such estimates must be confirmed by periodic real-time potency tests on at least three different batches throughout the period of time indicated by the expiry date, and 3–6 months beyond.
Testing on products containing viable organisms is done at the time of release and at the approximate expiry date until a statistically valid record has been established. Stability testing provides the opportunity to test for residual moisture and for other important parameters, such as the stability of adjuvant emulsions.
GMP Pharmaceuticals has set up special laboratories and organised teams in New Zealand and China to conduct professional and efficient stability testing. These teams ensure that all tests meet the technical and regulatory requirements.
- Health Sharing Group
- Natures King