Pharmacists are expected to be aware of and comply with relevant practice standards and guidelines on compounding. Despite certain exceptions, compounded medicines must meet the quality standards set out in the Therapeutic Goods Act 1989 (Cth).
GMP training for compounding pharmacies continues to be a hot topic at SeerPharma and the Pharmacy Board of Australia continues to work closely with Therapeutic Goods Administration (TGA) and other stakeholders on reform of the regulatory framework for pharmacy compounding.
Recently, SeerPharma successfully designed and delivered a GMP training and competency program to support onsite aseptic preparation within South Australian public hospital pharmacy departments.
"The SeerPharma team led by David Spaulding worked in a professional manner to deliver a robust, high quality and contemporary GMP training program. I would most definitely recommend SeerPharma to design a GMP training program to meet the needs of any private or public pharmaceutical manufacturing provider."
Alan O’Kane, Senior Project Pharmacist,
Statewide Manufacturing Services, SA Pharmacy
The program comprised of 2 courses designed for groups involved in compounding pharmaceuticals:
GMP for Pharmacy Operations - Level 1
(pharmacists, pharmacy assistants and quality control)
GMP Train-the-Trainer Program - Level 2
(SA Pharmacy staff training to be certified GMP Trainers)
SA Pharmacy GMP Trainers, trained by SeerPharma, now have the ability to describe and apply the key principles of GMP with a focus on Quality Management and Production; and understand the specific requirements and standards for aseptic operations including Operator validation.
The overall objective was to provide SA Pharmacy with the skills, materials and knowledge to independently train and assess pharmacy staff within their network on GMP.
To design and develop the course, SeerPharma collaborated with Senior SA Pharmacy staff to adhere to standards applicable to South Australian public hospital pharmacy departments:
- National Competency Framework for Pharmacist in Australia
- Advanced Pharmacy Practice Competency Framework
- Relevant standards of the Society of Hospital Pharmacists of Australia (SHPA)
- PIC/S GMP Guides; including PIC/S Guide to Good Practices for the preparation of medicinal
products in healthcare establishments
- ISO standards; including ISO 14644 Cleanrooms and associated controlled environments
SeerPharma also utilised SA Pharmacy training materials and relevant materials from a variety of SeerPharma training programs such as:
- International GMPs and Quality Assurance
- GMPs for Manufacturing Operations
- Contamination Control
- Good Aseptic Practices and Sterile Products
- Integrated Quality Management
- Applying Pharmaceutical Risk Management
Train-the trainer courses were delivered over 5 days, with 3 days spent on theory and 2 separate days spent on practical training and a final assessment. SA Pharmacy’s SeerPharma certified GMP Trainers have successfully delivered 1-day GMP training programs in-house since February 2017.
Contact us to discuss this program and how we can assist your compounding pharmacy operations, including TGA licensing.
This post comes from our April 2017 Journal. You may also be interested in:
- GMP Training for Complementary Medicines Manufacturer
- Good Aseptic Practices Training for Medical Device Company
- GMP - What You Need to Know