Gil Roth08.12.13
Gareth Adlam has been named Quality Assurance director at the Nottingham, UK-based formulation and development site of Aesica Pharmaceuticals. As an experienced Qualified Person (QP), Mr. Adlam has 15 years of pharmaceutical expertise, including six years in practice as a QP professional. Prior to qualifying as a QP, he worked as a pharmacist, before taking on roles in scale up, product development and R&D compliance .
In his new role, Mr. Adlam’s main goal is to drive batch certifying procedures and to bring high quality, best practice expertise to bear in QP services, applying his knowledge and success 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. Aesica now has 15 QPs in operation across its Zwickau, Nottingham, Queenborough, Pianezza and Monheim sites, further enhancing its international offering to customers. The company performs full release of commercial products to the market, providing this service for the bulk of products that it currently manufactures.
Aesica Pharmaceuticals has established a Quality Assurance team focused on delivering a range of Qualified Person (QP) services across oral, topical , inhalable and parenteral dosage forms in Investigational Medicinal Products (IMP) clinical trial release, combined with the capability to assess other alternative formats. The move is intended to enhance the QP service offering provided by Aesica through its network of qualified European QPs who routinely release clinical trial supplies into the clinic. It will also bolster the company’s QP EU release service offering for clinical trial products manufactured in non-EU countries, including in the U.S. 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.
In his new role, Mr. Adlam’s main goal is to drive batch certifying procedures and to bring high quality, best practice expertise to bear in QP services, applying his knowledge and success 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. Aesica now has 15 QPs in operation across its Zwickau, Nottingham, Queenborough, Pianezza and Monheim sites, further enhancing its international offering to customers. The company performs full release of commercial products to the market, providing this service for the bulk of products that it currently manufactures.
Aesica Pharmaceuticals has established a Quality Assurance team focused on delivering a range of Qualified Person (QP) services across oral, topical , inhalable and parenteral dosage forms in Investigational Medicinal Products (IMP) clinical trial release, combined with the capability to assess other alternative formats. The move is intended to enhance the QP service offering provided by Aesica through its network of qualified European QPs who routinely release clinical trial supplies into the clinic. It will also bolster the company’s QP EU release service offering for clinical trial products manufactured in non-EU countries, including in the U.S. 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.
