THE IMPORTANCE OF QUALITY IN COMPOUNDED VETERINARY MEDICINES

Transcription

1 THE IMPORTANCE OF QUALITY IN COMPOUNDED VETERINARY MEDICINES

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3 GOOD MANUFACTURING PRACTICES On the 12th of June 2015 Bova was the first pharmacy in Australia to be granted a licence to manufacture veterinary chemical products. This licence has been issued by the Australian Pesticides and Veterinary Medicines Authority (APVMA) under licence It was issued after the Bova facility underwent two audits, both over two days, by the APVMA that involved the participation of both an independent auditor and a representative of the APVMA. This success is a demonstration of the ongoing commitment that Bova has made, and continues to make, to improve the quality of extemporaneous medications used by Australian veterinary practices. It is a journey that commenced in 2010 and one that continues each day as new products and practices are developed within the Bova facility. It is important to recognise that as a requirement of receiving this licence Bova was required to demonstrate to the APVMA that its systems, facilities and procedures meet the Code of Good Manufacturing Practice (cgmp). These are the same high quality standards adhered to by all commercial manufacturers of veterinary pharmaceuticals. 3

4 bovavet.com.au WHY IS IT IMPORTANT TO USE PRODUCTS SUPPLIED BY A PHARMACY LICENSED BY THE APVMA? The quality of a compounded medication is a vital component of a successful clinical outcome. Only high quality medications, free from contamination by bacteria or other medications, can be expected to result in consistent therapeutic outcomes. As a licensed pharmacy, Bova has subjected itself to oversight by the APVMA. Traditional pharmacies are not subjected to any independent oversight of their internal operations. Instead they are governed by legislation that provides them an exemption from this requirement. Although many pharmacies may claim to have facilities and processes that are of a high quality, only Bova can say its veterinary compounding processes and procedures have been audited by the APVMA and found to be of a satisfactory standard to receive a licence to manufacture. By choosing to use a cgmp licensed pharmacy you are providing your clients with treatments that you can be confident: Contain the correct amount of medication; Are prepared free of bacterial contamination; Are prepared free of contamination by other drugs which may cause adverse reactions.

5 WHAT DOES QUALITY AT BOVA ACTUALLY MEAN? In order to achieve a licence to manufacture, Bova has demonstrated a rigid system of quality assurance. Whilst many pharmacies may claim they have a system of quality control, Good Manufacturing Practice standards require more than simple quality control. They require a system of quality assurance that demonstrates that the facilities, staff and products meet the regulatory standards of an external auditing body. 5

6 bovavet.com.au 1 QUALITY FACILITIES Bova has always considered its facility to be a world class establishment. Bova operates and maintains: 18 clean workstations for the preparation of oral and topical compounds; A dedicated sterile laboratory and workstation; A dedicated negative pressure cytotoxic laboratory and workstation. After the cgmp audits Bova can confidently claim that the facility has been independently certified to meet the highest manufacturing standards for veterinary pharmaceuticals. In order to maintain this quality the facilities undergo: Regular independent monitoring of each of the 18 clean workstations and cytotoxic laboratory and workstation to ensure that they are maintained and monitored to comply with Grade C environmental conditions as set down by cgmp; Regular independent monitoring of the sterile workstation to ensure that it remains, and is maintained to, a Grade A environmental standard as mandated by cgmp; Routine independent monitoring of the entire laboratory by TGA approved and certified microbiologists to monitor the level of background bacterial contamination in both the sterile and non-sterile laboratories as required by cgmp; Regular internal, external and NATA calibration of all scales, weights, measures and measuring devices, such as ph meters, to ensure they are accurate when measuring the ingredients that go into your client s compounded pharmaceuticals; A system of rotational auditing and maintenance of current service contracts with specialised teams of engineers and technicians to ensure that all equipment is maintained in working order in compliance with international, Australian and internal standards; Full recording and traceability on all service events to provide assurance that equipment only ever operates to the highest standards as mandated in the cgmp code.

7 2 QUALITY STAFF Staff have always been one of Bova s biggest assets and training has always been a key priority in order to produce medications of the highest quality. This commitment to training is now backed by a comprehensive system of training protocols and continuous evaluation. To demonstrate compliance with cgmp Bova has developed and implemented a system of training evaluation that involves: Internally testing staff s ability to clean implements using, amongst other things, UV methods to identify any failures in cleaning protocols; Executing internal test protocols, qualifications, which involve preparation and extensive external testing by TGA facilities to ensure they are producing products which meet their labelled particulars; Ensuring only approved procedures are conducted by suitably qualified staff; Providing a system of training in the principles of cgmp to ensure that all staff understand the importance of quality in procedures relating to pharmaceutical preparation. 7

8 bovavet.com.au 3 QUALITY PRODUCTS Bova believes in the importance of building quality into its processes. In addition to all of the processes previously mentioned, it is important that a system of quality control is implemented that tests end products to ensure they are of the standard demanded by cgmp. Simply testing a product once is not sufficient. In order to achieve a licence to manufacture Bova was required to develop a system of quality assurance and quality control. Although Bova has always had a system of quality control that involved independent analysis by an overseas laboratory, cgmp requires more than that. It requires: Development of documented specifications for all raw materials and finished products; Sampling and testing of raw material and finished products by TGA or APVMA licensed facilities to confirm their compliance with Bova specifications; Developing a system of quality control for finished products, including trend analysis and the regular reviewing of results over time; Implementation of strict release procedures for each product during production and ultimately at the end of production; Conducting a comprehensive system of process validation for all product types that involves extensive scientific testing of all aspects of production to demonstrate the processes reliability as a method for production; Developing a programme of on-site testing of equipment prior to its use with a view to demonstrating its ability to reliably prepare veterinary products; Implementing a progressive system of stability management that involves systematic evaluation over time of the shelf life of all products produced under the licence. With 18 clean workstations including dedicated sterile and cytotoxic workstations, Bova is a world class laboratory. It is a clean, environment controlled area equipped with the latest equipment. These facilities are necessary when compounding to a high standard and have been audited and approved by the APVMA for the manufacturing of veterinary chemical products.

9 INDEPENDENTLY REGULATED STANDARDS Bova follows strict guidelines when preparing all medications. This ensures the quality and consistency of our products is above any rival compounding pharmacy. Bova complies with: Australian Pesticides and Veterinary Medicines Authority licencing conditions; Pharmacy Board of Australia Compounding Guidelines; Published pharmacy practice standards; Australian Standards for clean rooms. 9

10 CLINICAL MASTER S SCHOLARSHIP Bova has partnered with the University of Sydney Veterinary Faculty to offer a scholarship to an Equine resident over a three year period. This partnership is important to Bova as it demonstrates a commitment to the future of the veterinary profession. The recipient, Felix Chia, is studying towards a combined Master of Veterinary Science and Master of Veterinary Clinical Studies degree in the stream of equine surgery. His enthusiasm for equine welfare and ambition to become a specialist in equine surgery make him well deserving of this scholarship. In helping to train veterinary professionals, Bova hopes to contribute to advances in clinical practice and research that will lead to improved animal health and welfare, not only within Australia but internationally. Bova

11 PRODUCT TRIALS EXTENDED BEYOND USE DATES As part of Bova s commitment to product quality it has supported studies into a number of our leading products. Full details on the studies can be obtained by contacting our director of research and development, Dr Ben Sykes BSc BVMS MS Dip ACIVM Dip ECEIM MBA at ben@bovavet.com.au. Small animal Pimobendan Cyclosporine Trilostane Methimazole Pimobendan, Benazepril, Spironolactone combination tablet (under investigation) Equine Omeprazole Deslorelin acetate Deslorelin acetate/hcg combination Esomeprazole Further testing has been performed to extend the beyond use date, otherwise known as expiry date, on some products. This is a time consuming process and is difficult to perform on the wide variety of drugs, strengths and forms that Bova is able to supply. Bova has gone the extra mile for medications that clients have asked for longer beyond use dates on. Small animal Pimobendan solution: From 6 months to 12 months Trilostane tablets: From 6 months to 12 months Equine Deslorelin acetate: From 6 months to 12 months 11

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