GMP in pharmaceutical product manufacturing – a matter of course, long established and yet dynamic, subject to ongoing change. With knowledge of new and old GMP topics and their regulatory intricacies, gempex is able to provide individual and professional support. Services include GMP compliance consultancy, GAP analysis, risk management, concept implementation or optimisation, qualification of typical pharmaceutical equipment, validation of the manufacturing and cleaning processes, analysis methods and preparing for inspections – gempex offers solutions tailored to meet all GMP requirements in the pharmaceuticals industry.
A competent team of experienced experts provides support for GMP in all areas of pharmaceutical product manufacturing. From pure consultancy to integrated or partial project execution to providing personnel through Onsite Execution.
Select Service Examples*
- Production and Filling of Sterile Pharmaceutical Products
GMP compliance consultancy with subsequent qualification after a relocation, evaluation of qualification documentation and the qualification status of existing packaging lines
- Manufacturing Blood Plasma Products
Regulatory GMP compliance consultancy
- Reconstruction of Clean Rooms for the Production of Clinical Test Preparations
GMP support with the preparation of performance specifications, design reviews, GMP risk analyses, supplier selection and qualification
* Since we highly value the trust and confidentiality of our customers, we purposefully refrain from disclosing our customers in general. We will gladly provide you with specific references on request.