Develop, implement, monitor and update quality systems to control the distribution of medicinal products
Overview
This standard is about developing, implementing, monitoring and updating quality systems to control the distribution of medicinal products.
You will be responsible for developing the quality system and confirming colleagues understand their role and responsibilities, as well as monitoring the implementation and compliance with the relevant legislative and organisational requirements.
The quality system should include: the supply chain activities of procuring, holding, supplying or exporting medicinal products, excluding supply to the public; confirming product integrity; and complying with current legislation, regulations and guidelines, and organisational requirements.
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This standard is for the nominated Responsible Person (RP) engaged in the distribution of medicinal products.
Performance criteria
You must be able to:
develop and implement organisational quality systems to control the distribution of medicinal products
confirm that any existing organisational quality systems relate to the control of the distribution of medicinal products
- update existing organisational quality systems to control the distribution of medicinal products
- confirm that organisational activities for the distribution of medicinal products are defined and systematically reviewed
- monitor the quality systems and take Corrective and Preventative Action (CAPA) where the quality system is not meeting organisational requirements to control the distribution of medicinal products
- confirm that colleagues understand their roles and responsibilities for the relevant quality systems
- confirm that the size, structure and complexity of the distributor's activities have been considered when developing or updating the organisational quality systems
- implement change using a suitable change control system
- confirm the quality systems are formally documented and include an internal process management review
- confirm the quality systems cover outsourced activities, where these are used
- confirm the quality systems incorporate Quality Risk Management (QRM), which is based on scientific knowledge and is linked to the protection of the patient
- monitor and update the quality systems to meet the relevant legislative and organisational requirements
Knowledge and Understanding
You need to know and understand:
- your organisation's quality systems in relation to the distribution of medicinal products
- the roles and responsibilities of colleagues in your organisation for maintaining quality
- the activities of your organisation in relation to the distribution of medicinal products
- how to develop and implement quality systems to control the distribution of medicinal products
- how to monitor and update existing quality systems for controlling the distribution of medicinal products
- how to keep up to date with current developments, tools and techniques in quality management, and the quality expectations of customers and other stakeholders
- how to keep colleagues up to date about their roles and responsibilities in relation to Good Distribution Practice (GDP) quality standards, in accordance with the relevant legislation and organisational requirements
- how to confirm that organisational systems and plans are in place to meet the organisational quality standards
- how to communicate information relating to the quality systems within your organisation
- the formal documentation required for your organisation's quality systems and the internal management review process for it
- how to take Corrective and Preventative Action (CAPA) where the quality system is not meeting organisational requirements
- how to document Corrective and Preventative Action (CAPA) in accordance with the relevant legislation and organisational quality standards
Scope/range
Quality system includes all items as per the Medicines and Healthcare products Regulatory Agency (MHRA) rules and guidance:
- clearly specified management responsibilities
- delivery to the right recipients within a satisfactory time period
- making records contemporaneously
- documentation and investigation of deviations from established procedures
- taking appropriate Corrective and Preventative Action (CAPA), in line with the principles of quality risk management, where there are deviations from established procedures
- maintaining written job descriptions for key positions and the arrangements for deputising
- appointed Responsible Person (RP)
Formal documentation for the quality system should include:
- achievement of quality system objectives
- assessment of Key Performance Indicators (KPIs) including: complaints, deviations, Corrective and Preventative Action (CAPA), changes to processes, outsourced activities, self-assessment processes (risk assessments and audits), external assessments (inspections, findings and customer audits)
- emerging regulations, guidance and quality issues
- innovations to enhance the quality system
- changes to the business environment and objectives
- quality manual
Scope Performance
Scope Knowledge
Values
Behaviours
Skills
Glossary
Change control system:
the common or shorthand name in the industry for the "Rules and Guidance for Pharmaceutical Distributors" which is published and kept up to date by the Medicines and Healthcare products Regulatory Agency (MHRA).
Good Distribution Practice (GDP):
the part of quality assurance that ensures that the quality of medicinal products is maintained through all stages of the supply chain. This refers to the procurement, holding, storage or distribution of medicinal products to retailers, pharmacies, wholesale dealers or the person authorised to supply medicinal products, who must be in possession of the relevant authorisation issued by the Secretary of State. The distribution of medicinal products includes both those for human and veterinary use and must comply with the rules and guidelines on Good Distribution Practice (GDP).
Medicinal products:
a substance or combination of substances administered to humans or animals through injection, application, oral ingestion, inhalation, and so forth, whose purpose is to treat or prevent disease.