With the US FDA joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S), compliance with the PIC/S GMP standards should be a priority for any pharmaceutical manufacturer exporting to multiple countries.
What is PIC/S?
As described on the PIC/S website,the mission of the PIC/S organisation 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.”
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 (audit). Note that product registration is still required in each country – it’s the GMP audit results that are being shared.
Why is PIC/S compliance important?
A company manufacturing and supplying pharmaceuticals to multiple countries would be subjected to audits from the regulatory bodies of each country. For those countries who are members of PIC/S, an audit by another PIC/S member country will be accepted without the need for a further audit.
Let’s look at an example:
Company X ships product to Australia, Singapore and Malaysia. They have been audited by the Australian regulatory body, the Therapeutic Goods Administration (TGA) and have been granted a GMP licence. As Australia, Singapore and Malaysia are all members of PIC/S, Singapore and Malaysia will accept CompanyX’s products without their regulatory bodies peforming an audit on Company X. Once one PIC/S member country has confirmed that a manufacturer meets GMP requirements then all other PIC/S member countries will usually accept the GMP certification without performing and inspection and assessment themselves.
So, being assessed as PIC/S GMP compliant will significantly reduce your compliance burden and costs if you are supplying product to multiple countries.
What’s so significant about the US joining PIC/S?
With nearly 40 countries being members of PIC/S, most of the Western world, and more than 75% the pharmaceutical spend, is represented.
From January 1st 2011, the US FDA became members of PIC/S. This means that companies currently exporting or wanting to export products to the USA will be able to do so without a specific FDA GMP audit (well, that’s the theory anyway). If a manufacturing site has successfully passed a GMP audit from another PIC/S member country, then the FDA should accept that without further investigation.
So which PIC/S authority should you choose to receive your GMP certification from? Here are some of the considerations:
- Some authories don’t conduct many foreign audits, so it’s worthwhile asking first.
- Some are very expensive – request a quote
- Some are held in higher esteem by the public than others, so having their GMP certification will be better for you commercially
For specific advice, based on your individual situation, PharmOut can provide consultancy services.