Below is a summary of the measures that OMEGA compounding pharmacy undergoes to ensure quality assurance:
- Develop and implement standard operating procedures (SOPs): Our team has developed and implemented stringent SOPs that outline the procedures and protocols for compounding medications. Our SOPs include instructions for each step of the compounding process, such as selecting the appropriate ingredients, weighing and measuring ingredients, mixing the ingredients, and packaging the medication. These Standard operating procedures are reviewed annually or as directed by our in-house quality assurance supervisor.
- Use of High quality Ingredients: Omega Compounding always ensures that it uses the highest quality ingredients that are appropriate for the intended use and are sourced from reputable Australian sources.
- Train and educate staff: All our staff members involved in the compounding process receive training and education on the compounding process, as well as on the relevant laws and regulations. This process is repeated annually and or as needed when additional education is deemed necessary.
- Conduct regular testing: We conduct regular testing on a wide variety of our compounded medications to ensure that they meet the required specifications for potency, purity, and sterility. Omega Compounding Group is proud to be partnered with The National Institute of Complementary Medicine (NICM) at the University of Western Sydney. As a result of this partnership, we have a local dedicated service for testing finished compounds.
The NICM provides the perfect partnership for Omega compounding through aligned rigorous quality procedures. Holding a TGA licence, Australian customers can have peace of mind that their products will be tested to the highest Australian standards.
NICM HRI is one of only two university laboratories licensed by the Australian Therapeutic Goods Administration (TGA) to undertake and provide certificates of analysis for medicinal products in line with regulatory requirements.
Their fully equipped laboratories support our lab with independent and accredited testing and research services, including:
- Authentication of botanical identity of raw herbs and identification of active ingredients.
- Assay and potency testing – Herbals, Active Pharmaceutical Ingredients and compounded pharmaceutical preparation in all dosage forms.
- Analytical method development and validation.
- Stability testing – physical and chemical; batch to batch quality assurance.
- In house Quality assurance Programs: Omega Compounding has established a thorough in-house quality assurance program to test and maintain the quality of our Compounded Products. Our quality assurance program is governed by the following parameters:
A: End product testing for each Medication in the program
B: Regular calibration and inspection of Balances used in measurement of ingredients used to make each medication. This is a A&D certified process.
C: Random batch and product testing to test quality and shelf life.
D: Maintain appropriate documentation: We maintain detailed records of each step of the compounding process, including the ingredients used (including batch numbers and expiry dates), the equipment used, and the results of any testing. - Adhere to relevant laws and regulations: We adhere to all relevant laws and regulations, including those related to compounding, labelling, and dispensing of medications.
- Continuously review and improve processes: Our team endeavours to continuously review and improve its processes to ensure that we provide high-quality compounded medications to all our clients.
By implementing these steps, our pharmacy can ensure that it is providing safe and effective medications to its clients while also complying with all relevant laws and regulations.
If you would like some more information about our stringent Quality assurance program, contact our team today.
