QUALITY ASSURANCE / CONTROLS COMPOUNDED CODE OF PRACTICE
Safety and quality are of the utmost importance in compounding. Precautions are taken in the Laboratory to offer maximal protection for both the compounder and the patients who will receive the compounds.
Compounded*you are unique* is a member of PCCA, a professional body with more than 3,900 independent community pharmacists in the United States, Canada, Australia, and other countries around the world. (3)
Our Strict procedures and extensive compounding knowledge can ensure that every compounded product that leaves our State Of Art Laboratory is of the highest quality the patient deserves as quality is our main ingredient.
Compounded’s Active and Non-Active Pharmaceutical Ingredients are obtained from TGA suppliers (Medisca and PCCA) where possible, and seeks to use ingredients from Good Manufacturing Practice (GMP) suppliers approved by the Therapeutic Goods Administration (TGA) or the USA Food & Drug Administration (FDA). In fact, all our ingredients and equipment adhere to the latest pharmacopeia editions: USP, BP, EP, NF, FCC and ACS (1). The MSDS (Material safety Data Sheets) and CofAs (Certificate of Analysis) of each ingredient is available upon request.
Our compounding pharmacists and all our lab technicians have received extensive accredited training and keep up-to-date with the latest research and technology. We attend seminars and conferences to keep improving our knowledge in Compounding and Integrative Medicine with organisations including: ACNEM, A5M, MINDD, AIMA and Bill Walsh.
QUALITY ASSURANCE & CONTROL procedures within Compounded include:
• Daily temperature monitoring and documentation.
• Daily refrigerator monitoring and documentation.
• Daily calibration of analytical balances.
• Calibration of pH meter before each use on every compounded preparation.
• Active and Non Active Pharmaceutical Ingredients and Chemicals weight verified by computer and pharmacist.
• Independent lab testing of air and equipment cleaning and maintenance.
• Testing of Raw Materials for identification, purity & heavy metals.
• Testing end products to ensure correct potency or strength.
• Regulated storage of raw materials and end Compound preparations.
• Staff trained and certified in procedures for each type of Compounding.
• Documentation and Files for each Personnel’s completed training courses, continuous internal and external compounding training.
• Standard Operating Procedures (SOP’s) for quality and consistency.
• Purpose built State Of Art Laboratory to eliminate cross contamination.
• Compounding software for continuous record keeping and documentation:
– Lot numbers
– Expiration date.
– Stock Control and Quarantine.
– Prescription numbers
– Patient medical history, Allergies, and other special notes (adhere to Privacy Act of Australia)
• Risk Category Analysis before compounding for each prescription:
– Active Ingredient: (eg potency, toxicity, evidence for use, Use in pregnancy/lactation precautions, contraindications, TGA registered or not)
– Compound preparation: (eg complex dosage form, high potency, low dose, storage, Poison Schedule, presentation)
– Special patient population: (eg.gender,geriatric/paediatric, renal/hepatic impairment, comorbidities)
Compounded sets the standards for compounding. Customers can feel comfortable in the knowledge that the Compounded ‘Code of Practice’ sets standards that are of high quality which is the result of Professional Care, Ingredient Standards, Standards Operational Policies & Procedures, Continuous education and development and great customer service.
(1). PHARMACOPEIA STANDARDS (2)
The product is certified to conform to the prescribed specifications listed in the current edition and subsequent supplements of the U.S. Pharmacopeia.
The product is certified to conform to the prescribed specifications listed in the current edition and subsequent supplements of the British Pharmacopeia.
The product is certified to conform to the prescribed specifications listed in the current edition and subsequent supplements of the European Pharmacopeia.
The product is certified to conform to the prescribed specifications listed in the current edition and subsequent supplements of the National Formulary.
The product is certified to conform to the prescribed specifications listed in the current edition and subsequent supplements of the Food Chemical Codex.
The product is certified to conform to the prescribed specifications listed in the current edition and subsequent supplements of Reagent Chemicals published by the American Chemical Society.
Assigned to chemicals of high purity, suitable for use in analytical laboratories.
Assigned to chemicals of superior quality for which there is no official standard.
Assigned to chemicals which have the clearance for use in food and related products.
Assigned to chemicals suitable for use in the cosmetic industry
(2). Medisca Australia: www.medisca.com
(3). PCCA Australia: www.pccarx.com.au