In a two–day education programme called GMP in Storage, Distribution and the Cold Chain, our principal pharmaceutical quality consultant, Afshin Hosseiny, completes a distinguished panel of expert speakers who will share their knowledge and experience of GMP requirements and current developments in storage, transportation and cold chain management.
Dr Hosseiny has worked closely with organiser Concept Heidelberg to design a programme for presentation on behalf of the European Compliance Academy (ECA) at a time when globalisation, counterfeiting problems and heightened expectations regarding the storage and transport of medicines are forcing the industry to challenge its current practices.
Guides, guidelines and initiatives from various agencies such as EMEA, FDA, WHO and USP lead the way in this development and define expectations and requirements. The WHO guide to good storage practices for pharmaceuticals recommends that: “Materials and pharmaceutical products should be transported in such a way that their integrity is not impaired and that storage conditions are maintained.”
While temperature-sensitive materials present particular challenges, regulatory scrutiny is not reserved for the cold chain. In the fiscal year 2005, 43% of all critical and major deficiencies recorded by MHRA’s GDP inspectors were in relation to the control and monitoring of storage and transportation temperatures.
John Taylor, of the UK Medicines and Healthcare Products Regulatory Agency (inspection and enforcement division), said: “Control of storage and transportation temperatures is essential in maintaining the quality of medicines and in helping to protect patients from sub-standard or ineffective medicines that may result from inadequate control.”
The education course, which will be held in Berlin from 18 February to 19 February 2010, is designed to help those involved in the storage and/or transportation of medicines understand what these requirements involve in practice and how to implement effective controls.
Whether your involvement is with commercial distribution of licensed products, the handling of material for clinical trials or the development of a new product, the course provides an opportunity to gain an insight into current developments and share best practice.
The programme includes sections called:
- European and International Regulatory Requirements and Guidance Related to Storage, Transportation and Cold Chain
- Best Practices in Storage (includes a live demonstration of temperature mapping)
- Cold Chain Management and its Validation
- Best Practices in Transport and Logistics
- Security in the Supply Chain
- Couriers and Carriers: Qualification and Contracts
- Workshop on Quality and Risk Management Throughout the Supply and Cold Chain
- Workshop on Documentation
The first step in establishing the effective control required is an accurate and reliable temperature map of your facility. Tabriz Consulting’s unique end-to-end temperature mapping service, Tabriz Coolmap, provides expert analysis, action planning, validation, training and ongoing support in addition to the initial mapping exercise.
Tabriz Coolmap’s temperature mapping and reporting gives customers confidence that their products are stored at the specified conditions, as well as ensuring that they pass MHRA/IMB/FDA inspections.