Legislation and Guidelines for the Laboratory sector are focused on ensuring that testing is carried out to the appropriate Quality Standard, to ensure that the regulations concerning temperature experienced by  samples for testing and medicinal and blood  products are stored and transported at the correct temperatures.

Below we have referenced a selection of documents, both legislation and guidance, to give a flavour of the requirements surrounding the laboratory sector.

QUALITY MANAGEMENT SYSTEMS

• International Standard ISO 15189 (Medical laboratories – Particular requirements for quality and competence
• Directive 2005/61/EC regarding traceability requirements and notification of serious adverse reactions and events

STORAGE & TRANSPORTATION OF MEDICINAL PRODUCTS/SAMPLES

• EU GDP Guidelines 2013/C 343/01
• HPRA “Guide to Control and Monitoring of Storage and Transportation Temperature conditions for Medicinal Products and Active Substances”, IA-G0011-1 Date 05/10/2011
• MHRA “Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007 – the “Orange Guide”

REGULATIONS & GUIDANCE SPECIFICALLY FOR BLOOD & BLOOD PRODUCTS

• The Blood Safety and Quality Regulations 2005 and The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005 (UK) and Blood Safety and Quality (Amendment) Regulations 2006 No. 2013
• Statutory Instrument No. 360 of 2005 (Quality and Safety of Human Blood and Blood Components) Regulations.
• Directive  2005/62/EC regarding Community standards and specifications relating to a quality system for blood establishments.
• Directive 2004/33/EC – regarding certain technical requirements for blood and blood component.
• Directive 2002/98/EC – setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components
• Amended by Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC

ELECTRONIC RECORDS

• EudraLex – Volume 4 – Annex 11 – Computerised Systems
• FDA “Guidance for Industry Part 11, Electronic Records, Electronic Signatures Scope and Application   J:\!Guidanc\5667\fnl doc – Date 28/08/2003

Further Information

• Health Products Regulatory Authority    www.imb.ie
• MHRA www.mhra.gov.uk
• Food & Drug Administration (FDA) www.fda.gov