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Gold Standard – Responsible Person, Medicinal Products

Gold Standard – Responsible Person, Medicinal Products

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The Gold Standard, Responsible Person Medicinal Products was released in June 2014.

The expectations for “Responsible Person Medicinal Products” are as follows;

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.

Technical - the individual can…

Perform duties including:

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 individual has…

  • 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
Compliance

the individual understands…

  • 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

The individual shall…

  • 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

Additionally the individual understands…

  • 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