We are quality professionals, offering consultancy services to support small to medium sized pharma/device companies to generate or repair their quality management systems to ISO/GDP/GMP.
We specialise in QARA services and can provide a contract RP for medicinal product wholesale activities.
Matt Curtis
Owner and Director
I started offering services as a sole trader back in 2017, after working for two of the top 10 global pharmaceutical companies, and a small MAH with wholesale activities. With 30 years’ experience ranging from analytics, stability, regulatory, product development, quality management and outsourcing. I then realised, that the thing I like to do the most is to help people with their quality challenges. The business received a refresh in 2022 with the name Copperhead linking my passion for brewing beer at home.
Copperhead can provide the following services as standard, others on request, or a mixture of the services listed.
Medical device manufacturers must meet the requirements for a quality management system that can be used by an organization involved in one or more stages of the life cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal. Pharmaceutical manufacturers or MAH must achieve their quality objective reliably. There must be a comprehensively designed and correctly implemented Pharmaceutical Quality System incorporating Good Manufacturing Practice and Quality Risk Management.
Regulation 45 of the Human Medicines Regulations 2012, as amended, requires that all licensed wholesale dealers should have at their disposal at least one person available as the Responsible Person (RP). The Responsible Person should have appropriate competence and experience, as well as knowledge of and training in Good Distribution Practice. Contract RPs are a significant feature within this industry.
GxP (where x stands for GMP, GLP, GVP or GDP) is a set of regulations and quality guidelines that aim to address the safety of the pharmaceutical product in a systematic and effective manner while maintaining the quality of processes throughout every stage of manufacturing, control, storage, and distribution.
Personnel should receive initial and continuing training relevant to their role, based on written procedures and in accordance with a written training programme. The RP should also maintain their competence in GDP through regular training.
After the inspection closing meeting, you will receive a post inspection letter confirming any deficiencies found. You must respond to the inspector by email to confirm the proposed corrective actions and dates (CAPA) for when these actions will be completed. Remediation is putting these CAPA into effect and making sure effectiveness checks are proportionate.
During normal manufacturing or wholesaling medicinal products/medical devices, planned events can go wrong or deviate. Feedback or customer complaints must be addressed and investigated. The same for deviations and planned changes. You may need advice as to best document these events and proceed.
Lucy from SS - “Matt is an invaluable asset as our contract RP, seamlessly balancing his helpful and friendly demeanour with an unwavering commitment to GDP compliance.”
Please send us a message using the form below. We will then follow up to determine your requirements.
