Manufacturing
Spectrumceuticals Pty Ltd product manufacturing process consists of in-house R&D, pilot plant, CMO’s and 3rd party accredited laboratory testing services
R&D LABORATORY
Since August 2022, Spectrumceuticals have commenced operations at our new R&D Laboratory in Morisset Newcastle specialising in nano-cell technology product applications.
INGREDIENT SOURCING
Spectrumceuticals source ingredients from particular companies due to their patented products, published evidence when possible, good manufacturing practices (cGMP) and the integrity of their certificate of analysis and adherence to regulatory requirements.
cGMP Listed Medicines
Our principal manufacturing partners are focused on Quality Assurance and is and cGMP compliant. Our CMO has spent extensive effort, time and testing costs to fully validate the manufacturing process’s from start to finish and hold multiple TGA cGMP licenses. Our products are listed on the Australian Register of Therapeutic Goods
TESTING AND SAFETY
We conduct the mandatory finished product testing as required by regulatory;
Batch identification – checking our suppliers ingredients are identified correctly
Ingredient assay – ensuring the label claim for each and every ingredient is within specification
Microbiological – analysis of yeast, moulds, bacteria, staphylococcus aureus, e. Coli and salmonellae are within specification
Contaminants – heavy metals
STABILITY PROGRAM
We conduct a mandatory comprehensive 3rd party stability program across our ARTG listed medicines. This program ensure that there is stability data to support the shelf life of the product, have adequate information to support the shelf life of the product being released and we have adequate information to confirm that the batch meets the requirements for marketing authorisation. Our label storage conditions are mostly ‘store below 25°C’ with conducted studies at 25 ± 2°C and 60% ± 5% relative humidity and ‘store below 8°C (refrigerate)’, with conducted studies at 5 ± 2°C