Quality Control

QUALITY ASSURANCE / CONTROLS COMPOUNDED PTY LTD 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 Pty Ltd 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 ensure that every compounded product that leaves our state-of-the-art laboratory is of the highest quality the patient deserves — because quality is our main ingredient.

Our Active and Non-Active Pharmaceutical Ingredients are obtained from TGA suppliers (Medisca and PCCA) where possible, and we always seek to use ingredients from Good Manufacturing Practice (GMP) suppliers approved by the Therapeutic Goods Administration (TGA) or the USA Food & Drug Administration (FDA).

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 are available upon request.

Our compounding pharmacists and lab technicians have received extensive accredited training and stay up-to-date with the latest research and technology. We attend seminars and conferences to continuously improve our knowledge in Compounding and Integrative Medicine with organisations including: ACNEM, A5M, MINDD, AIMA, and Bill Walsh.

QUALITY ASSURANCE & CONTROL PROCEDURES WITHIN COMPOUNDED PTY LTD

Daily temperature monitoring and documentation.
Daily refrigerator monitoring and documentation.
Daily calibration of measurement equipment.
Calibration of pH meter before each use.
Active and Non-Active Pharmaceutical Ingredients and Chemicals weight and composition verified by computer and pharmacist.
Independent lab testing of air and equipment.
Independent third party testing of raw materials for identification, purity & heavy metals.
Quality assurance for end products to ensure correct potency.
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, internal and external compounding training.
Standard Operating Procedures (SOPs) for quality and consistency.
Purpose-built state-of-the-art laboratory to eliminate cross contamination.
Compounding software for continuous record keeping and documentation (adhering to the Privacy Act of Australia)
Risk Category Analysis before compounding for each prescription:
- Active Ingredient: potency, toxicity, evidence for use, pregnancy/lactation precautions, contraindications, TGA registration status, and more
- Compound Preparation: complex dosage form, high potency, low dose, storage, poison schedule, presentation, and more
- Special Patient Population: gender, geriatric/pediatric, renal/hepatic impairment, comorbidities, and more

Compounded Pty Ltd sets the standard for compounding. Customers can feel comfortable knowing that our Code of Practice aims high, resulting in professional care, strict ingredient standards, comprehensive SOPs, continuous education, and excellent customer service.

GLOSSARY AND REFERENCES

Pharmacopoeial Standards
- USP: U.S. Pharmacopeia
- BP: British Pharmacopeia
- EP: European Pharmacopeia
- NF: National Formulary
- FCC: Food Chemical Codex
- ACS: American Chemical Society
- REAGENT: High purity for analytical labs
- PURIFIED: Superior quality with no official standard
- FOOD GRADE: Approved for use in food
- TECHNICAL GRADE: Suitable for cosmetic industry
Medisca Australia: www.medisca.com
PCCA Australia: www.pccarx.com.au