Job role skills, knowledge and behaviour
Responsible Person Medicinal Products
Approved On:
24/03/2016 Version:
2.0
The Human Medicines Regulations require a distributor to designate a Responsible Person(s), named on the applicable licence. Regulation 45 and the EU GDP Guide set out the requirements and the responsibilities. Where the RP is contracted to a company, the duties remain the same as for those of the permanently employed RP.
TechnicalComplianceBusiness ImprovementFunctional & Behavioural
Quality Management-the individual shall ensure that a quality management system proportionate to the distributor’s activities is implemented and maintained including:
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quality risk management
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corrective and preventative actions (CAPA) to address deviations
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change control
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measurement of performance indicators and management review
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Personnel-the responsible person is required to:
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understand their own responsibilities
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carry out all duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance
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define personal and staff roles, responsibilities and accountabilities and record all delegated duties
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ensure that initial and continuous training programmes are implemented and maintained
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ensure all personnel are trained in GDP, their own duties, product identification, the risks of falsified medicines and specific training for products requiring more stringent handling
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maintain training records for self and others and ensure training is periodically assessed
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Premises & Equipment
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ensure that appropriate standards of GDP are maintained for own premises and contracted storage premises
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identify medicinal products, legal categories, storage conditions and different Marketing Authorisation types
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maintain the safety and security of medicinal products within the appropriate environments, including product integrity and product storage
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use the appropriate systems to segregate, store and distribute medicinal products
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maintain records for the repair, maintenance, calibration and validation of equipment including computerised systems
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ensure storage areas are temperature mapped, qualified and validated
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Documentation-the individual shall focus on:
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the accuracy and quality of records
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contemporaneous records
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records storage
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maintaining comprehensive written procedures that are understood and followed
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ensure procedures are valid and version controlled
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Operations
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carry out due diligence checks and ensure that suppliers and customers are qualified
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ensure all necessary checks are carried out and that medicinal products are authorised for sale
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manage authorised activities to ensure operations do not compromise the quality of medicines and can demonstrate compliance with GDP
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demonstrate the application of activities and provisions in accordance with the wholesale distribution authorisation and of company processes and procedures
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ensure that any additional requirements imposed on certain products by national law are adhered to e.g. specials, unlicensed imports & controlled drugs
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Complaints, returns, suspected falsified medicinal products and medicinal product recalls
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ensure relevant customer complaints are dealt with effectively, informing the manufacturer and/or marketing authorisation holder of any product quality/product defect issues
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decide on the final disposition of returned, rejected, recalled or falsified products
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approve any returns to saleable stock
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coordinate and promptly perform any recall operations for medicinal products
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co-operate with marketing authorisation holders and national competent authorities in the event of recalls
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have an awareness of the issues surrounding falsified medicines
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Outsourced Activities
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approve any subcontracted activities which may impact on GDP
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Self-Inspection
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ensure that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place
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Transportation
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apply the appropriate transport requirements and methods for cold chain, ambient and hazardous product
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ensure all transport equipment is appropriately qualified
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Brokers
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ensure that transactions are only made with brokers who are registered
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ensure that any broker activities performed are registered
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the prior relevant knowledge and experience related to the distribution of medicinal products
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access to pharmaceutical knowledge and advice when it is required
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knowledge of the products traded under the licence
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if not a pharmacist or QP, one year's relevant practical and managerial experience of medicinal products
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the role of MHRA in the licensing of medicines and as the competent authority including the risk-based inspection process, the role of the enforcement group, the inspection action group (IAG), and resulting actions that can be taken due to non-compliance
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the UK regulations in relation to wholesale distribution
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the european pharmaceutical directive related to wholesale distribution of medicinal products
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good distribution practice (GDP)
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the importance of a clear reporting line to the wholesale distribution authorisation holder, senior manager and/or CEO
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employ due diligence in the discharge of their duties, maintaining full compliance to procedures and appropriate regulations
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report to senior management, the marketing authorisation holder and the MHRA any suspicious events of which they become aware
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the role of the professional bodies and organisations that regulate those supplying medicinal products to the public e.g. GPhC
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the role of the home office in relation to the handling of controlled drugs
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the role of the veterinary medicines directorate (VMD) in relation to veterinary medicines
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the role of the european medicines agency (EMA) and use of EUDRAGMDP
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the falsified medicines directive
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the principles and guidelines of good manufacturing practice and how the principles of GDP maintain product quality throughout the distribution chain
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practise continuous improvement practices and utilise appropriate tools and techniques to solve problems
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basic skills in
- English (level 2)
- Mathematics (level 2)
- ICT
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take responsibility for planning and developing courses of action, including responsibility for the work of others
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exercise autonomy and judgement within broad but generally well-defined parameters
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develop and implement operational plans for their area of responsibility
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manage diversity & discrimination issues
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provide leadership for their team
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ensure effective delegation whilst retaining ownership of the outcome
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develop and maintain productive working relationships with colleagues and stakeholders
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monitor the progress and quality of work within their area of responsibility
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manage their professional development by setting targets and planning how they will be met
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review progress towards targets and establish evidence of achievements
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put across ideas in clear and concise manner and present a well-structured case
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communicate complex information to others
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understands the business environment in which the company operates
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has an appreciation of the industry sector and competitors
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understands the customer base and is aware of customer requirements
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