• PIC/S:  The Evolution and Advantages of Harmonisation

Chromatography

PIC/S:  The Evolution and Advantages of Harmonisation

Sep 10 2015

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. 

Choosing partners for laboratory solutions, who understand and can support your needs for GMP compliance, can help you confidently meet this challenge. Waters' Empower 3 Chromatography Data Software along with the expertise of Waters' Global Services provide a versatile, functional and compliance-ready Chromatography Data System which can help you address elevated regulatory expectations.  

Learn more about Waters compliance-ready services, go to www.waters.com and search for 720005222en, or direct link: http://www.waters.com/waters/library.htm?cid=511436&lid=134830333

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


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