Checks and balances

National Custom Compounding uses a thorough internal process to ensure a high quality compound is produced on all occasions.

All of the following checks are completed by two (2) separate pharmacists:

  • Formulation check from prescription to dispensing
  • Medication or preparation is compounded
  • Our final check encompasses:
  1. Correct ingredients
  2. Correct formulation
  3. Correct weight of ingredients used
  4. Integrity of product
  5. Physical presentation (dosage form, packaging and labelling)

All of the systems are integrated through a software system which enables complete tractability.

API (Active Pharmaceutical Ingredients)

To maintain the integrity of the completed product National Custom Compounding adheres to a strict management process for storage of its raw ingredients and components.

Raw ingredients are sourced from Australian importers and TGA approved wholesalers. Each API is supplied with a certificate of accuracy (CoA). We randomly sample and test new products to ensure the CoA are accurate.

Facility Setup

Our facility was also built in line with the PSA (Pharmaceutical Society of Australia) and USP (United States Pharmacopoeia) guidelines. These are in place to make sure that the facility holds patient safety as the priority when medications are made.

To avoid cross–contamination the laboratory has three (3) separate rooms.

Each room has a designated function

  1. Hormones
  2. Vitamins/nutritional
  3. Dermatological and other preparations

Equipment

  • All equipment at National Custom Compounding is maintained and calibrated according to USP standards (United States Pharmacopeia) and checked annually by Filtertech Australia and CSK Group.
  • Each lab room is equipped with a powder containment hood with appropriately maintained HEPA filters.
  • Each room has its own air supply through individual airconditioning units.

Personal Safety

Personal Safety is of the upmost importance at National Custom Compounding. Routine bloodtest screening on hormone levels are provided every six (6) months for all laboratory staff.

All laboratory staff wear appropriate protective equipment which includes

  • Gown
  • Mask
  • Gloves
  • Eye wear
  • Boots
  • Hair Netting

Independent Laboratory Testing

National Custom Compounding voluntarily participates in an independent laboratory testing of its compounds to test for 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(1), three(3) and six (6) months.

Testing is conducted by RTH Scientific Services, Brisbane and the National Institute of Complementary Medicine, Herbal Analysis Laboratory (HAL), Penrith.

Registration

National Custom Compounding (referred to as NCC) is registered as a Compounding Pharmacy with the Pharmacy Board of Australia. It meets all guidelines as required by the Pharmacy Board. NCC is also a QCPP (Quality Care Pharmacy Practice) certified, which is managed by the Pharmacy Guild of Australia.

All compounding pharmacist are registered under AHPRA and meet CPD (continuing professional development).

Pharmacy Memberships 

Image result for pharmacy guild

National Custom Compounding and Gooding Drive Amcal Chemist, is a member of the Pharmacy Guild of Australia, the Australian College of Pharmacy, the Professional Compounding Chemists of Australia (PCCA) and a QCPP – Quality Care Pharmacy Practice accredited pharmacy. It also holds a Medicare PBS approval.

Standard Operating Procedures

National Custom Compounding ensures that all of the compounding operation runs in line with a series of strict Standard Operating Procedures (SOP).

These SOP ensure that when a product is ordered, formulated, dispensed and compounded, the process remains consistent every time. The benefits of a consistent process is that the compounded medicine will remain at the high standard and our patients will receive the benefits every time.

National Custom Compounding’s SOP’s have been developed in conjunction with Medisca International’s recommendation.

Staff Training

On the 28th of April 2015, the Pharmacy Board of Australia released new guidelines on Compounding Medicine. To meet these standards, any Pharmacist working in National Custom Compounding must be specifically trained. We have chosen to partner with Medisca International who provide a highly respected pharmacist training course.

Quality Systems includeImage result for pharmacy guild qcpp

  • Internally developed and integrated, order, dispensing, formulating and compounding platform.
  • QCPP (Quality community pharmacy standards) and SOP (Standard operation procedures) inline with USP (United States Pharmacopea) requirements.
  • Logistic service to deliver Australia-wide.
  • Online Medicine Library of resources for Pharmacist and Patients.
  • A Unique Pharmacy Order portal for Pharmacies.

 

If you have any questions regarding the Quality Process that National Custom Compounding follows please email us or phone on 1300 731 755.