Everything about National Custom Compounding – from the purpose-built facility, state-of-the-art equipment, and strict procedures – is designed to provide Doctors, Pharmacists, and their patients, with the highest possible quality custom-made medicines.
NCC practices and operates under the following Quality Standards
- Standards Australia AS 1807:2021
- Australian Standard AS 85000:2017
- PIC/S Guide for Preparation of Medicine in Healthcare Establishments
- United States Pharmacopeia (USP) Chapters 795, 797 and 800
- Pharmacy Board of Australia Codes, Guidelines and Policies
- PSA (Pharmaceutical Society of Australia) Pharmacist Standards
- Queensland Health Medicines and Poisons (Medicines) Regulation 2021 (MPMR)
The NCC clinical team also ensure that our practice follows guidelines and standards particular to other states of Australia, when possible. Here are some of the steps we take to ensure unmatched standards:
1Personal Safety
To provide a safe and cheerful working environment, all National Custom Compounding Laboratory Staff undergo blood screening and hormone level testing every 6 months and are required to wear the following protective equipment when working:
- Gown
- Mask
- Gloves
- Eyewear
- Boots
- Hair netting
For more information about how National Custom Compounding’s custom-made medicines are superior quality, download our Quality Assurance Document or contact us.
2Staff Training
All National Custom Compounding staff undergo training developed in partnership with Medisca and PCCA to ensure they meet and exceed Quality Care Pharmacy Praactice standards and Pharmacist CPD requirement, required by the Pharmacy Board of Australia guidelines.
3Rigorous Systems
To ensure every medicine is consistent in quality, National Custom Compounding follows strict Standard Operating Procedures (SOP) that were developed in conjunction with Medisca International’s including:
- Internally developed and integrated order, dispensing, formulating, and compounding platform
- QCPP (Quality community pharmacy standards) and SOP (Standard operation procedures) in line with USP (United States Pharmacopeia) requirements
- Electronic, traceable, and integrated Logistic service to deliver Australia-wide through verified third-party providers
- Online Medicine Library of clinic resources for Pharmacist and informative resources for Patients
4Registration and Professional Memberships
- Quality Care Pharmacy Practice Certified
- Pharmacy Guild of Australia member
- The Australian College of Pharmacy member
- The Professional Compounding Chemists of Australia (PCCA) member
- Medicare PBS approved pharmacy premises licence
- All Pharmacists are registered with Australian Health Practitioner Regulation Agency (AHPRA) and meet continuing professional development
5Independent Laboratory Testing
National Custom Compounding undertakes regular independent laboratory testing for compound potency and shelf stability under “normal” (room temperature) and “accelerated” conditions (increased relative humidity 70% and temperature 45 degrees Celsius). These tests are undertaken at zero, one, three and six month intervals.
Testing is conducted by RTH Scientific Services, Brisbane and the National Institute of Complementary Medicine, Herbal Analysis Laboratory (HAL), Penrith. Read more about Stability Testing here.
6Triple Layered Quality Control
Every National Custom Compounding medicine undergoes three layers of quality control, is checked by a minimum of two separate Pharmacists, tracked through our advanced software system, and includes:
- Pharmacist Formulation check of the prescription during the dispensing stage
- Medication or preparation is compounded by qualified Compounding technicians
- Final Pharmacist check encompassing:
- Correct formulation SOP (standard operating procedures)
- Correct weight of ingredients
- Physical and Visual Integrity of product
7Purpose-Built Facility
After the recent expansion of National Custom Compounding’s (in September 2021) into a larger 300m2 compounding facility, NCC is now separated in 3 key, and this has enabled a much larger capacity for compounding.
The facility was designed and constructed in line with strict Australian Standards (AS/NZS 2982.1:1997), Pharmacy Board guidelines, PIC/S facility requirements and USP (United States Pharmacopoeia) guidelines.
The facility now comprises of 3 separate areas, that have physical and mechanical separation to ensure no cross contamination, and appropriate storage for all materials inside the specific area.
The areas are
- NCC Office and store
- Non-sterile compounding area
- Sterile Compounding area
8Cutting-Edge Equipment
After the NCC expansion, there has also been a significant investment in specialized equipment.
The specialized equipment utilized in NCC includes
- Air Science Purair Ductless Fume Hoods with HEPA filtration link here
- GERMFREE LFGI Pharmaceutical Isolators link here
- Mazerustar MAZ Centrifugal mixer link here
- RAM Resonance Acoustic Mixer link here
- Exakt Ointment mills link here
- Gako advanced mixing unguators link here
- Lighthouse 3016 handheld Particle Monitoring link here
- Lighthouse APEX Z50 Portable Particle Counter link here
- Lighthouse ActiveCount 100 Microbial Air Sample link here
- Innotech Building Management System
The advanced equipment at National Custom Compounding is maintained and calibrated according to Australian Standards (AS/NZ) and United States Pharmacopeia Standards (USP 795, 797), and certified annually by Laftech Scientific Services and Opira Group who are both NATA accredited testing facilities.
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