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Whatever your quality queries the Answer: is QA+ to look after all your compliance needs. Get in touch we are looking forward to working with you
Bringing over 50 years of combined, diverse experience the QA+ Team can provide the solution to your quality needs. From designing and building QMS systems to gap analysis, auditing and providing a remote QA function, our talented team can generate and strengthen quality systems, ensure your quality requirements are met and exceed your expectations.
Auditing
Auditing is a critical function to effectively manage and qualify third parties, ensure they are operating to the correct standards and gain an overview as to how effectively the company controls the quality of their processes. Auditing and audit schedules should be based on risk to determine the frequency and type of audit required. QA+ team members are skilled in auditing against GxP and ISO standards and can conduct audits on your behalf or as part of your audit team. For automated systems and websites, we can conduct Good Automated Manufacturing Process (GAMP) audits to ensure compliance. Additionally, to support with the continual improvement and evolution of your quality management system, QA+ can conduct a gap analysis of your entire system or a specific area of concern. This can identify and help to solve weaknesses before performing a formal audit.
Good Distribution Practice
Good Distribution Practice (GDP) describes the minimum standards that a wholesaler must meet to hold a Wholesale Distribution Authorisation (WDA) and GDP certificate. One of the requirements of a WDA holder is to designate a Responsible Person (RP) and/or a Responsible Person for import (RPi). The RP and RPi are responsible for safeguarding patients by ensuring that GDP requirements are complied with across the supply chain. Our QA+ team can evaluate your licence requirements, help to create and qualify your supply chain, build your GDP-compliant quality management system, support with the WDA application process, and provide both RPs and RPis to be named on your licence.
Responsible Person
The Responsible Person (RP) is responsible for safeguarding product users by ensuring that Good Distribution Practice (GDP) guidelines are complied with. As the UK is no longer part of the European Union, a wholesaler may require a Responsible Person for import (RPi). For example, if you are importing Qualified Person (QP) certified medicines, from the European Economic Area (EEA) into the UK, you may require an RPi. In comparison to the RP role, the RPi has additional responsibility, including implementing a system to confirm that the required QP certification has taken place. The RP/RPi must reside within the UK and be continuously contactable. QA+ can fulfil this obligation for your company by providing both RPs and RPis.
Inspection Planning
The MHRA is the UK licensing authority and will only issue a licence following a satisfactory site inspection. These inspections serve to demonstrate compliance to the appropriate standard and provisions of the licence. Following the initial inspection, sites are routinely inspected as part of the MHRA’s risk-based programme, or as part of the assessment of a major change to the licence. Our QA+ team have experience preparing for and hosting MHRA inspections and can ensure that both your site and staff are inspection ready. Post-inspection, we can help address any deficiencies raised and support you with MHRA responses, until the licence is granted.
Quality Management System
A legislative requirement of GxP is to have an effective Quality Management System (QMS) in place. The QMS should be all encompassing, with a complexity consistent with the activities being undertaken. Unique to your company and culture, the system must set out your processes, procedures, responsibilities, and risk management principles. In addition to being maintained, this system should be iterative, enabling learning through feedback and continuously improving. QA+ has successfully built a number of Quality Management Systems of varying complexity. The bespoke QMS can be built as a standalone system or incorporate your current international or corporate systems. Our diverse experience as a consultancy, enables us to build and develop a system that works for you.
Quality Events is a collective term we apply to risk management, deviation handling, control of change, corrective and preventative actions (CAPA), complaints management, returns assessment and recall activities. As the overall control strategy built into your company’s quality culture, these events are critical in managing and improving your quality system. Quality events must be reported, documented and investigated, and as an indicator of the health of your quality management system, these events are of particular interest to regulators. They allow the review of risk, corrective and preventive actions to be applied, and the effectiveness of the system to be reviewed frequently. Within QA+, we can support with your quality events, from providing interim support or advice to managing your quality events systems.
Good Manufacturing Practice
Good Manufacturing Practice (GMP) describes the minimum standard that a medicine manufacturer’s production processes must meet. This certifies that the medicinal products being manufactured are of a consistently high standard, appropriate for their intended use and in line with the requirements of the Marketing Authorisation. QA+ can provide experienced EEA-based or UK-based Qualified Persons (QP) to be named on your Manufacturer’s Import Authorisation (MIA), or you could utilise our EEA MIA to support your importation and batch certification requirements. The team can support with the preparation and submission of MIA applications and can audit to assure compliance with GMP requirements.
Transport and Logistics
Transportation is essential in ensuring your medicinal product is continuously available on the market. As a result of the UK leaving the European Union, transportation between the EU and the UK crosses a customs territory, making this more complex. Additionally, this process must be compliant with Good Distribution Practice (GDP) to maintain the integrity of your product, and ultimately protect patient safety.
Within QA+, our specialist team can support you with the required activities involved in the set up and maintenance of your supply chain. These activities range from the development of supply flows for both ambient and cold chain human medicines to conducting risk assessments and audits. Our team can guide and advise you on the benefits and costs associated with different haulage companies and transport routes, qualify and scrutinise your supply chain to ensure it is futureproof.
Development through Compliance
A medicinal product lifecycle involves many stages from development through to reaching the market and distribution to the end user. QA+ provides an established skillset to fulfil any knowledge, experience and personnel gaps that may arise throughout this cycle. The QA+ team has a diverse background, ranging from food stuffs to biologicals. Therefore, we are equipped to help you achieve your goals, whilst maintaining compliance, and an awareness of your business model.
Barnstaple Office
queries@qualityassuredplus.com
+44 (1271) 314320
Unit B5 Fishleigh Court
Fishleigh Road
Barnstaple
Devon EX31 3UD
Nottingham Office
queries@qualityassuredplus.com
+44 (1949) 20469
Brooks Suite
Unit 7D East Bridgford Business Park
Kneeton Road, East Bridgford
Nottingham NG13 8PJ
Ireland Office
queries@qualityassuredplus.com
+353 (0)43 339 8044
Unit 15, Daingean Hall
N4 Axis Centre
Longford
N39 W6K0