Aesica sets up a Quality Assurance team to deliver QP services

Appoints Gareth Adlam as Quality Assurance Director at Nottingham, UK facility

Aesica Pharmaceuticals has established a new Quality Assurance team focused on delivering a range of QP services across oral, topical, inhalable and parenteral dosage forms in Investigational Medicinal Products (IMP) clinical trial release.

The UK-headquartered contract manufacturer says the aim is to enhance the QP services provided through its growing network of qualified European QPs who routinely release clinical trial supplies into the clinic.

The move will also bolster the company’s QP EU release service offering for clinical trial products manufactured in non-EU countries, including in the US.

QP services at Aesica include full specification testing, carried out at the company’s GMP analytical laboratories, thereby enabling products manufactured in the US to be used in EU based clinical trials. Furthermore, Aesica handles importation licenses as an additional service to customers.

To support the move, the company has appointed Gareth Adlam as Quality Assurance Director at its Nottingham based formulation and development site.

Adlam is an experienced Qualified Person (QP), with a wealth of pharmaceutical expertise extending over 15 years, with six years acquired in practice as a QP professional. Prior to qualifying as a QP, Adlam worked as a pharmacist, before taking on roles in scale up, product development and R&D compliance.

In his new role, Adlam’s main goal is to drive batch certifying procedures and to bring high quality, best practice expertise to bear in QP services, applying the knowledge gained from his previous QP role to both small scale capabilities, as is the case at Nottingham, through to the larger commercial scale IMP sites in place within the Aesica Group.

Prior to joining Aesica, Gareth held multiple positions at 3M Healthcare including Value Stream QP with responsibility for certifying Commercial and IMP batches of product, reviewing and approving deviations and coaching and mentoring personnel regarding quality.

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