Batch Release Services
QC testing for drug release of pharmaceuticals and biopharmaceuticals in the EU and across the globe.
Good Manufacturing Practice for Medicinal Products require batch release within the European Community (EC) or European Economic Area (EEA) of medicinal products holding a marketing authorisation or made for export. You need a partner that can provide you with regulatory compliant QC testing in a turnaround time that shortens the period from product manufacture to availability to the patient. We offer batch release and lot release testing that requires both chemical and microbiology testing services, including:
- A wide range of analytical technologies including: HPLC (UV, PDA, FLU, ELSD, RI, CAD), UPLC (TUV, PDA, SQD), H-Class HPLC method development, LC/MS/MS, Maldi-Tof, GC, Isolator Technology, APSD (NGI, ACI), ELISA, SDS-PAGE
- Complete microbiological testing including: sterility testing, bacterial endotoxin (LAL) testing, bioburden analysis – harmonised absence of and total viable counts, microbial identification, preservative efficacy Testing, microbiological antibiotic assay, specialist microbiological method development and validation
- Complete compendial analysis (BP, EP, JP and USP)
- API, IMP, FP batch release testing and lot release testing for small molecules, inhaled products and biopharmaceuticals
- Method transfer and analyst exchange
Tepnel Pharma Services also has experience in batch release testing of products manufactured outside the EU.
Approved and accredited QC testing laboratory
Tepnel Pharma Services is an approved and accredited QC testing laboratory with a long history of batch release and lot release testing. We provide a wealth of experience across a wide range of small molecule, inhaled products and biopharmaceutical product types in accordance with the requirements of the MHRA and the FDA.
Sections in Batch Release Services
All cGMP Analytical Services
- ICH Stability Testing Services
- Batch Release Services
- Raw Material Testing Service
- Method Development and Validation