Both FDA and EU regulatory authorities expect dosage form manufacturers to carry out risk assessments of their supply chains.
The globalised nature of the pharmaceutical industry means that both active substances and part-processed dosage forms can be shipped around the world, with consequent risks of temperature instability, theft or counterfeiting.
Somerset House Consultants has recently carried out supply chain risk assessments and identified areas for improvement for a number of European companies, sourcing products from the Middle East, India and Asia.
Somerset House Consultants helps contract manufacturers to meet international quality standards and client expectations, provide quality assurance and qualified person release services for API, IMP and marketed products.
Our expert consultants ensure that work is carried out on time, on budget and in compliance with all current good manufacturing practice requirements.
For more information, please contact us or visit our website.