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