Supply Chain Oversight

Independent QA Oversight of our Supply Chain

Pharmaceutical supply chains often extend across multiple transportation routes and regulatory jurisdictions. Without Supply Chain Oversight these complex supply chains present challenges in terms of maintaining quality of medicinal product in-transit and the increasing global risk of Falsified Medicines entering the supply chain.

“Annex 16 of the EU GMP Guide requires that documented information on the entire supply chain of the medicinal product is made available to the QP in order for the QP to certify the pharmaceutical product for release to market. Mapping of the supply chain is applicable to the entire supply chain and should include the DS, high and medium risk excipients, intermediates, bulk and finished product transportation, storage and distribution facilities, and associated activities. It should ensure that facilities are licensed appropriately for the activities involved.”

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SUPPLY CHAIN OVERSIGHT

MIAS can provide a dedicated QP resource to oversee the quality of the company’s supply chain & quality-related issues.

SUPPORT & QUALITY

MIAS Supports

To support QP services and Quality of your products in the marketplace, we work with you to oversee Quality standards of your 3rd parties by:

  • Acting as your company’s GMP/GDP Quality Operations contract service provider in Europe.

  • Assessing and qualifying your GMP/GDP contractors, vendors and third parties through auditing, & Quality oversight activities.

  • Periodic reassessment of your GMP/GDP contractors and vendors as per your vendor management programme.

  • Preparing your Quality/Technical Agreements with your GMP/GDP contractors, vendors and third parties, to include assigning roles and responsibilities for Quality Assurance to both parties.

  • Monitoring and evaluating QA metrics reported for your GMP/GDP contractors, vendors and 3rd parties.

Through our Alliance network we can support:

Regulatory compliance of Shipment and Transportation activities
Regulatory compliance of Repackaging / Relabelling services
Regulatory compliance of Analytical Testing and Retesting
Compliance with responsibilities as a Market Authorisation Holder (MAH).
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