Our Regulatory
We have welcomed the introduction of regulated Good Practice into the distribution sector.
Importers and distributors were brought within the European regulatory framework following the implementation of the Falsified Medicines Directive in 2013, when we became registered with the UK Medicines and Healthcare Regulatory Agency.
The EU Guidelines for Good Distribution Practice for Active Substances for Human medicines came into force 21 September 2015. After their publication we completely revised the content and format of our Quality Manual to ensure that the written procedures for every aspect of our operation were compliant with the new guidelines.
Your Regulatory
We have a solid understanding of our customers’ regulatory requirements and we proactively anticipate your requests for certificates, statements and declarations etc. We understand your Change Control process for a new or second API source.
We will never propose a manufacturing source that we aren’t confident would meet our customers’ regulatory expectations.
Quality
On the rare occasion where a Quality issue arises we assume responsibility for the management of the resolution between customer and source, facilitating discussion and following agreed CAPAs through to close-out.
Supply Chain Security
Supply chain security is an integral part of the service package we provide. We take our responsibilities as keepers of the Good Practice in between the GMP of our suppliers and that of our customers extremely seriously.
We do things ‘by the book’ obviously: Written handling agreements with service providers; long term storage of APIs in MHRA registered premises; supply chain flow charts for every product etc etc.
But in addition to this there are some key elements to supply chain security which fall more within the realm of experience, know-how, and length of time in the business:
- We cultivate our relations with the individuals in the logistics departments of our manufacturing partners so we know who to speak to for the quickest answers
- We use third party logistics partners we know and trust and have worked with for many years.
- We choose to work with small partner companies where we have direct personal relations with the key staff and where responsibilities very clearly rest with an individual and are not ‘lost’ within a large organization
If it goes wrong…
And, as we live in the real world, we are prepared for the unfortunate event that something does not go to plan.
Our logistics partners fully understand the significance of any transit damage to pharmaceutical materials and have standing instructions to refer anything back to us for a decision prior to delivery.
From immediate identification and photographing of any damage, to return, recall, quarantine and eventual disposal if required, we have robust written procedures in place