Case Study: Developing a Global GMP Audit Programme to Support EU Product Launch

As part of preparing for their first European product launch, our client identified a critical compliance challenge: their entire supply chain was outsourced across multiple global contract manufacturing sites. Many of these facilities had not previously been inspected by an EU Qualified Person or EU Competent Authority, creating potential regulatory risk prior to market entry. The client needed a partner to assess GMP compliance, manage audits across their supply chain, ensure regulatory readiness before launch, and maintain post‑launch oversight.

How MIAS Pharma Helped

MIAS Pharma implemented a risk‑based, end‑to‑end audit management programme tailored to the client’s global network. We mapped the full supply chain, reviewed historical audits, assessed site risk, and built a prioritised audit plan agreed with the client.

Specialist EU Qualified Persons conducted audits at sterile manufacturing, QC and packaging sites under EU GMP/GDP requirements, with structured reporting and remediation tracking.

Advantages

Cost: By coordinating all audits under one programme, MIAS delivered financial efficiencies through a bundled approach rather than individual audits.
Expertise: Our multidisciplinary QP team brought specialised experience aligned to each facility type, providing robust, practical GMP assessments across all geographies.
Assurance: As MIAS also performed EU batch certification for the product, our audit oversight provided seamless alignment between supplier compliance and QP certification activities, reducing internal workload for the client.

Project Outcomes

• All supply-chain sites audited and verified for EU GMP/GDP compliance prior to launch.
• Successful EU product launch supported by QP certification readiness.
• Ongoing post‑launch audit programme implemented.
• MIAS acting as a single quality compliance hub.

How MIAS Can Support

MIAS Pharma supports companies entering or operating in the EU/UK with supplier audit programmes, QP batch certification, GMP/GDP remediation, inspection readiness and supply-chain quality governance.

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MIAS Pharma provides the following services:

QP Services

Clinical QP Services

Compatibility and stability studies

Personnel and training for QP, QA & RP

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