Responsible Persons for the Manufacture and Placing on the Market of Blood Products
- Manufacturer, Head of Production, Head of Quality Control, Qualified Person, Head of LQS/LQA
- Pharmaceutical entrepreneur, step-by-step plan officer, information officer
- Personal responsibility, delegation of Tasks
What are Audits and what are Inspections and what is the Legal Basis?
- EC Blood Directives and other international Guidelines
- The Guideline on Plasma-derived Medicinal Products
- Manufacture of medicinal products from blood or plasma - Annex 14
- How do the different pieces of legislation interlock?
Starting Materials for Blood Products
- Raw material / Production / Quality Control
- Virus inactivation/virus reduction
- Risk assessment for viral transmission and TSE
Drug Products from Plasma Fractionator
- Supplier qualification and Management
- Quality assurance for fractionation & processing of blood products
- Storage and transport of blood products
Contractual Agreements with Supplier of Plasma
- Key regulatory points for a contract between plasma fractionator and plasma centers/donation establishments.
EMA Plasma Master File (PMF) Certification Procedure and PMF Dossier Requirements
- PMF procedure
- Guideline on the Scientific Data Requirements for a Plasma Master File
- Inspection and audit requirements for PMF certification
Donor Documentation and Data Protection in Blood Establishments in the Light of the General Data Protection Regulation
- EU General Protection Regulation
- Donor documentation and archiving
Product Quality Review – PQR
- Regulations for a PQR
- Content of an PQR
- Deviation and CAPA Management
- Quality measurers in blood and plasma establishments
- Licensed and non-licensed products
Quality Management - Organisation and Relevant Persons
- Quality assurance during extraction & application
- Inclusion and evaluation of donors and donations
- Role of physicians
- Production, storage and transport of blood products
- Transfusion commissioner, responsible person for transfusion, quality officer
The Forthcoming Inspection: Preparation and Planning Phases
- Inspection by the authorities
- How to prepare for an inspection
- How to answer on inspection reports
- Supplier audits – qualification of contracted partners
The Procedure of Audits and Inspections Part 1: The Point of View of the Blood Establishment
- The donors‘ path through the centre
- Ways of the product
- Waste
- Deliveries
The Procedure of Audits and Inspections Part 2: Inspectors‘ Point of View
- Inspection focus for blood and plasma facilities
- Responsibilities and powers of inspectors
- Frequent errors and defects
The Follow-up of Audits and Inspections Part 1: Inspector’s Point of View
- The official inspection report
- Category of deficiencies and their significance
- Opinion on the inspection report (action plan)
The Follow-up of Audits and Inspections Part 2: The Point of View of the Blood Establishment
- Findings
- CAPA
- Responsibility of the persons involved (expert person, head of production, head of QC, QM, auditor, administrative assistance)