Legislation and regulations

  • Joe Harrington


In addition to regulations governing health, safety and training which is fully dealt with in Chapter 7. there are an increasing number of rules, regulations, certifications and ‘best practice’ procedures that directly or indirectly affect manufacturers and users of cleaning equipment. These include:-
  • European Community Directives

  • Environmental legislation — both national and international

  • Pharmaceutical manufacturing procedures and regulatory controls

With such a plethora of legislation and regulations, many companies are not fully aware of their responsibilities and, as in the case of health and safety legislation, non compliance may result in legal penalties or commercial sanctions.


European Union Safety Requirement Personal Protective Equipment Chlorinate Solvent Medicine Control Agency 
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References and Acknowledgements

  1. 9.
    R.G.Penn. The State Control of Medicines. `The first 3000 years’. British Journal of Clinical Pharmacology 1979.Google Scholar
  2. 11.
    US. Foods and Drug Administration.Guide to the Inspections of Validation of Cleaning Processes FDA Office of Regulatory Affairs. (July 1993)The Interpharm Group of Companies. 1358 Busch Parkway. Buffalo Grove. IL 60089 USAGoogle Scholar
  3. Cleaning Technology for Pharmaceutical Manufacturing. D.A.LeBlanc Pharmaceutical Technology 1993Google Scholar
  4. Validation of Cleaning Procedures: Report of an SFSTP Commission S.T.P. PharmaPratiques (1997)Google Scholar
  5. Cleaning Validation and Residue Limits: A contribution to current discussions Andreas O. Zeller Pharmaceutical Technology Europe. November 1993Google Scholar

Copyright information

© Springer Science+Business Media Dordrecht 2001

Authors and Affiliations

  • Joe Harrington
    • 1
  1. 1.PCTDurhamUK

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