QP Auditing

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QP Auditing

A full range of QP auditing service

All Eramol QPs are IRCA-trained lead auditors with extensive global experience in auditing the following product types and areas:

  • Chemical & biological Active substances (API)
  • Sterile & Non-sterile Drug Products
  • Biotechnological Drug Products
  • QC Laboratories including Data Integrity Audits
  • ATMP & Radiopharmaceutical Drug Products
  • Packaging & labelling sites
  • Warehousing & Storage sites
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Eramol also has several regional third-party approved auditors to provide additional global auditing capacity.

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Our Other Services

Formulation Development

Eramol offers clinical formulation development and manufacturing services to enable you to develop your product and speed up your time to market. We’ll work with you to develop an effective formulation – either in solid tablet, capsule or liquid form – giving you optimal clinical outcomes that can support your product across all clinical trial phases.

Sterile Manufacturing

Eramol delivers a purpose-built, EU GMP Annex 1–compliant sterile manufacturing service dedicated to Phase I and Phase II clinical trial supply. Our facility is designed for agility, reliability, and regulatory strength by integrating advanced isolator technology, closed-system processing, moist heat terminal sterilisation and a full end-to-end clinical supply chain — ensuring your sterile injectable, cartridges and pre filled syringes reach patients safely, on time and in full regulatory compliance.

Non Sterile Manufacturing

GMP Production of Tablets, Capsules & Oral Liquids for Phase I–III and Commercial Supply Eramol delivers end-to-end non-sterile manufacturing built on a foundation of quality, regulatory expertise, and Qualified Person (QP) leadership. Our Sevenoaks GMP facility, commissioned in November 2021 and operational since August 2022, supports the full product lifecycle—from early-phase clinical development right through to commercial supply.

Clinical Packaging

We recognise that the challenge of acquiring adequate placebos is considerable, whether it be matching a placebo or making an active comparator.

Labelling Solutions

Our versatile and extensive labelling solutions have been designed to offer flexibility, economy of scale and to meet the demands of last-minute requirements.

EU & UK QP Release

QP Release is a critical stage in clinical trials: it is the process whereby Qualified Persons (QPs) ensure that a batch of investigative medicinal products (IMPs) that has been manufactured are of a high enough quality that they can be released for use in clinical trials.

Reliable. Proven. Safe. Effective.

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Reliable. Proven. Safe. Effective.

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Speak With Us

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Email

enquiry.uk@eramol.com

Phone

+44 (0) 1293 368080