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Quality is the Best Manufacturing Plan

At NexGen Pharma we believe that quality is a holistic commitment and a fundamental principle in every step of the production process. We believe quality is not only founded in the end product and resulting efficacy. But that quality originates from the facility and raw materials used and extends beyond purchasing a product to post customer care service and the establishment of trust.

Our team has embodied quality as part of our dogma to ensure the medication we provide is reliable and accurate. NexGen Pharma uses a site designed and purpose built to facilitate the provision of industry leading compounding services. We also use a comprehensive system of supplier monitoring and review to ensure that only raw materials that adhere to world standards set down in the British Pharmacopeia and United States Pharmacopeia are used.

Extending from our foundation built on quality, we operate with a leading team of pharmacists, compounding and dispensing technicians and customer care specialists. Our team has used their 80 years plus cumulative experience in the industry to refine a series of processes and procedures that have become our protocol to yield the highest quality medications. All our products are subject to our purpose developed quality management system to ensure they are reliably accurate, pure and free from microbial contamination.

We also believe that quality means continuous improvement. That’s why NexGen Pharma provides proactive and accessible industry leading post-sales support to ensure medication is being used in the most optimal way.

Quality assurance procedures include:

  • Daily temperature and humidity monitoring and documentation;
  • Daily refrigerator monitoring and documentation;
  • Daily calibration of analytical balances;
  • Chemical weight verified by computer and pharmacist;
  • Daily calibration of pH meter;
  • Ongoing training, testing and evaluation of aseptic personnel;
  • Scheduled certification of sterile environment;
  • Monthly independent lab testing of air and surface samples for the cleanrooms;
  • Cleanrooms tested by NATA certified personnel, exceeding guidelines with a class 6 cleanroom;
  • Continuous cleaning of compounding environments by qualified and approved third party technicians;
  • Compounding software with backup for continuous record keeping:
    • Formula
    • Procedure/technique
    • Lot numbers
    • Prescription numbers
    • Expiration dates
  • Chemicals obtained from approved TGA suppliers where possible;
  • Regulated storage of raw materials.

To ensure the standard of excellence in compounding  NexGen Pharma:

  • Incoming raw materials go through the test of Certificate of analysis
  • Colour coding of capsules is implemented to identity medication types and strengths
  • Our trained pharmacists check the ingredients and calculations of each medication by its own production worksheet for audit trial
  • All raw ingredients are subject to a quality assurance check. The ingredients are checked, weighed and stored separately in their own-labeled container. The quality and accuracy of the ingredients is checked each time.
  • After the medication is prepared, it is then subject to a final test by our highly trained pharmacists. This is to ensure that the medication meets all the requirements of the prescription for the patient