PIC/S:  The Evolution and Advantages of Harmonisation

You may have heard the acronym PIC/S (the joint name of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) but do you know what it really means for the evolution of the pharmaceutical industry?  

From the PICSCHEME website, PIC/S' mission is ‘to lead the international development, implementation and maintenance of harmonised Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products’ [1]. It achieves this by working with regulatory agencies across the world, being a vehicle for sharing inspection data, harmonising GMP standards and training local inspectorates. PIC/S has been specifically successful working with regulatory agencies in Asia.

PIC/S is not a regulatory agency itself, has no control over local government or regulatory bodies and it does not have its own inspectors.  Regulatory agencies may become members if they have:  a law on medicinal products, a Good Manufacturing Practices (GMP) guide equivalent to PIC/S, a GMP inspectorate that fulfils PIC/S quality system requirements, and experienced inspectors. If GMPs are not available or lacking in a country they might consider  ‘adopting and adapting’ the PIC/S GMP guide  into their own GMP regulations. 

Trevor Schoerie captured the key advantage of PIC/S very simply in his post in the PIC/S  LinkedIn Group; “in practical terms, this means that if a country joins PIC/S they will recognise GMP inspections and assessments done by other PIC/S member countries – without the need for another inspection.” As Trevor brings to our attention “countries where the Authorities are PIC/S members now represent 70% of the spend on drugs” so, for a company looking to address those markets, an understanding of the PIC/S GMP Standard in increasingly important [2].  

This provides significant advantages for the members of PIC/S countries, companies and consumers in today’s global market.  Member countries are able leverage other audits reducing the costs of inspections.  Companies will have a harmonised view of GMP expectations and reduce time spent hosting inspections. Consumers have a stronger assurance that the products they are using meet the same quality standards. 

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1. REF: www.picscheme.org/
2. Ref: Trevor Schoerie, Managing Director, PharmOut Pty Ltd (Australia)  
  https://www.linkedin.com/grp/post/3747902-6043229525880352772?trk=groups-post-b-title