Monitoring for Regulatory Compliance & Product Safety
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Regulatory Guidelines

Guidance for the pharmaceutical sector focuses on the control of the manufacturing and (increasingly complex) distribution processes to ensure products of appropriate quality are produced, and that quality is maintained without alteration throughout the supply chain. Essentially the focus is on the Quality Management Systems in place and their implementation to achieve the above objectives.

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

  • 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
  • HPRA “Guide on Wholesaling of Medicinal Products for human use in Ireland”, IA-G0008-1 Date 29/09/2011
  • HPRA “Guide to the Quality System for Grocery Wholesale Distributors” AUT-G0075-1 Date 17/06/2011
  • FDA “Guidance for Industry Part 11, Electronic Records, Electronic Signatures Scope and Application J:\!Guidanc\5667\fnl doc Date 28/08/2003
  • European Communities (Animal Remedies) (No 2) Regulations 2007 (SI 786/2007)
  • IATA perishable cargo regulations chapter 17
  • MHRA “Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007 – the “Orange Guide”
  • EudraLex – Volume 1 – Pharmaceutical Legislation Medicinal Products for Human Use
  • EudraLex – Volume 4 – Annex 11 – Computerised Systems
  • Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
Further Information

Further information on the above is available from the websites of the regulatory agencies which are as follows