Our GDP Services
External and Internal GDP Audits
Audits are a critical part of the GDP compliance process. We can provide a full independent overview of your current practices, processes and procedures and assess their adherence to appropriate regulatory standards. A summary audit report will identify areas of non-compliance and suggested areas for improvement. This will significantly reduce your risk of a poor outcome from your next MHRA inspection, potentially saving your business time, money and reputational damage.
Audits can be undertaken for end to end processes or specific areas of the business. They can also be performed to mirror regulatory inspections.
We can also audit third parties on your behalf to exacting GDP standards as part of your ongoing quality processes and as a critical part of GDP compliance. Each audit will provide a summary report identifying strengths in addition to potential areas of concern or non-compliance on which to base your commercial and quality decisions.
Training
GDPPC offers an extensive range of both training and development services ranging from group training provision to one-to-one coaching. GDPPC’s training is unique in that Peter and Claire have delivered GDP training packages to Inspectors working for regulators across the globe and are now in the position to provide that expertise to industry.
Training packages can be tailored and delivery attuned to suit the capabilities and experience of the audience. Training can range from an hour to a number of days, depending on content and client requirements. Interactive sessions, discussion of relevant topics amongst delegates and informally with the trainers is encouraged throughout.
As experts in the GDP field, we provide a service where we work with you to review your current training provision and to identify gaps. We provide realistic proposals in terms of tailored solutions. We will analyse your business, interview key personnel and consider any performance management data in order to provide an appropriate solution.
Bespoke Courses
We can provide a wide range of training packages covering every aspect of GDP which can be tailored to your specific needs and which can be delivered remotely, at your premises, or in any other suitable venue. This service consists of a preliminary discussion in relation to your specific needs and is then followed with design of the course material to reflect those requirements. Following this, production of training materials, delivery of the course, and a certificate of completion for each delegate is provided.
One-to-One Training.
Focusing on specific areas of development for key personnel within your organisation and can be delivered face to face or remotely. These can be on any GDP related subject and tailored to an individual or teams needs. They can be booked in hour long blocks to provide the maximum cost effectiveness to your organisation.
Open Training Courses
Training courses at a number of venues throughout the year will be available. These courses will have set syllabuses and cover such aspects as the RP Gold Standard, Quality Management Systems, transportation considerations, environmental considerations etc which represent good value. You will have the opportunity to mix with people from other organisations and gain the opportunity to share ideas and experience.
Quality System Design
It is a legal requirement that all businesses who hold a Wholesale Dealers Authorisation (WDA) must operate a fully documented Quality Management System (QMS). Such a system should set out the responsibilities, processes and risk management principles in relation to the business.
GDPPC can create a comprehensive, yet easy to navigate QMS which will be tailored to your individual business needs and which will help to ensure compliance with the regulatory requirements of both the Human Medicines Regulations 2012 and the Guidelines on Good Distribution Practice of Medicinal Products.
Effective quality management in the GDP arena is important because it prioritises and controls potential hazards in the holding and distribution of medicines. By controlling major risks such as physical contamination or product degradation caused by poor practices the industry can better assure both regulators and consumers that medicinal products are safe. Additionally, effective application of quality management principles will reduce the potential for both reputational damage and financial risk through improved regulatory compliance and continuous improvement.
WDA Application and Wholesale Business Model Set-up
If you are looking to set up a business model that trades in medicines, either as a brand-new company or as part of an existing company, we can assist with the set-up of this at every step of the way. From navigating through the MHRA application process to ensuring that that the business model you have in mind is suitable and compliant with the associated regulations. We can provide all the necessary quality documentation that will be tailored precisely to your business and ensure your business is inspection ready in order to commence trading.
Responsible Person (RP) and Responsible Person for Import (RPi) Provision
Legislation requires any holder of a Human Medicines Wholesale Dealers Authorisation to designate a person as a “Responsible Person” (RP). The RP must be suitably qualified and have the appropriate competence and experience as well as relevant knowledge of Good Distribution Practice (GDP).
Having the appropriate Responsible Person named on your authorisation is critical to ensure your business operates in a complaint manner and follows regulations accordingly.
Since Brexit, there is an additional requirement for licenced products imported from the EEA to undergo additional checks via an RPi. More details can be found here: https://www.gov.uk/guidance/acting-as-a-responsible-person-import
GDP Pharma Consulting are highly experienced and are able to act effectively in the RP/RPi role in any size or type of wholesale authorisation holder currently operating in the UK.
As part of our RP/RPi service provision we will conduct an initial review of your active or proposed business to establish the required level of RP/RPi input to ensure GDP compliance and your regulatory obligations.
Consultation and Guidance
We offer consultation on all aspects of GDP, whether you are developing or significantly changing your business or are looking for confirmation that it is operating in compliance with regulations. Areas of support and guidance generally include compliant business models, process compliance, transport, procurement and supply routes and export. provisions We can also provide consultancy on physical structures such as warehousing, including providing recommendations and suggesting solutions in areas such as refrigeration, HVAC systems, calibration requirements, materials management, process optimisation and IT systems.
We have a large number of long-standing clients for whom we provide advice to on an ad-hoc basis in a supporting role.
Remediation Services
Unfortunately, even with the best intentions, sometimes things can go wrong and in the highly regulated area of pharmaceutical wholesale this can lead to considerable fiscal and reputational damage, in addition to having a potential public health impact.
In these circumstances we can provide a targeted and rapid service to analyse the issues that have been identified and provide practical solutions and design systems to ensure improved future compliance that will be acceptable to the regulator.