The success and quality of Phase I-IIa clinical trials is highly dependent on the conditions of trial execution. Next to the management of subjects and investigator responsibilities, ensuring the drug candidate is handled by pharmacists with significant research experience, and stored, prepared and administrated properly is crucial. That is where our GMP pharmacy services can help.
Why choose GMP pharmacy services from SGS?
Our GMP pharmacy services offer you:
- Flexible dosing during the study
- No outsourcing needs for manufacturing and QP release activities
- The facilitation of ordering and production of small IMP volumes inherent to Phase I
- Packaging and labelling tailored to the site
- Cost reduction and shorter timelines
Highly Experienced GMP Pharmacy Services from a World Leader
Our Phase I clinical pharmacy is embedded in our clinical pharmacology unit (CPU) based in Antwerp, Belgium, and offers over 35 years’ experience in optimizing safety, reliability and efficiency of early phase clinical trials.
Our CPU pharmacy is GMP compliant, and allowed to perform IMP manufacturing activities, in accordance with Eudralex Vol 4, GMP annex 13 and Belgian circular 596 requirements. The pharmacy is temperature and humidity controlled throughout, and consists of dedicated dispensing, storage and preparation (class D) areas with laminar air flow cabinets (class A), as well as material and human pass boxes and a GMP clean room (class C).
Our pharmacy is staffed with full-time licensed pharmacists and pharmacy technicians. GMP supervision is performed by our in-house Qualified Person (QP).
Our CPU pharmacy provides a comprehensive range of services, including:
- Storage and dispensing of controlled drugs
- Preparation of study specific pharmacy manuals
- Manufacturing activities, such as capsule filling
- Dispensing and reconstitution activities
- Preparation of suspensions of solutions for internal use
- Imports of medicinal products from non-EU countries (sterile, non-sterile and biologicals)
- Packaging, including secondary packaging and primary packaging (relabelling)
- Batch QP release and certification
Contact us today to learn how we can help with safe and efficient investigational medicinal product preparation.