The importance of 3rd Party oversight – MIAS Services
The pharmaceutical industry has experienced significant globalisation of the supply chain over recent times. Outsourcing is gaining increasing popularity and plays a key role in today’s medicines production.
Introducing external third-party links in your supply chain increases complexity, with communications now passing back and forth outside the Contract Giver’s own systems. This can sometime involve different time-zones, cultural, and language barriers. Complexity increases the risks to security of supply, quality, and compliance.
Regulatory authorities are increasingly sensitive to the potential supply, patient safety, and compliance issues associated with complex supply chains. There is a focus on ensuring that suitable control and management oversight systems exist and ensuring that the systems are consistently applied.
Revisions to EU GMP Guide Chapter 7 effective in January 2013 relating to GMP Vendor Management have emphasised the importance of the written Contract between the Contract Giver and the Contract Acceptor where the outsourced activity is clearly defined, agreed and controlled to avoid misunderstandings which could result in a product or operation of unsatisfactory quality. The Contract should clearly establish the duties of each party. In addition, EU GMP Guide Chapter 7 requires that the Contract Giver
· Takes responsibility for control of outsourced activities
· Assesses the legality, suitability and competence of the Contactor Acceptor to carry out the outsourced activities in compliance with GMP, GDP and/or other appropriate guidance
· Monitors and reviews the performance of the Contract Acceptor and the identification and implementation of any needed improvement.
The importance of third party oversight will ensure product quality across the entire lifecycle of the contract. The oversight is key to ensuring:
· Establishment of effective systems and procedures for the initial evaluation of vendors
· Implementation of a robust process for notification issues and trends that may affect product quality.
· Use of quality risk management processes.
· The supply chain is mapped beyond the vendor i.e. What do you know about your vendor’s suppliers? Do you have an oversight on complexity of your supply chain?
· Continuous monitoring of your vendors throughout the agreement.
· Controls and systems are maintained at both contract giver and contract acceptor.
· Key indicators of vendor’ performance are identified
Third party oversight is critical for any parties where an activity is outsourced. MIAS Pharma Ltd provide quality oversight for activities associated with the importation and certification of client company medicinal and investigational medicinal products for human use within the EU/EEA including activities.
If you are interested in exploring how we can help you, please get in touch to discuss how MIAS Pharma Limited can assist your organisation, contact us at +353 01 846 3605/4 or firstname.lastname@example.org.