Quality Laboratories at BioTechnique®
Ensuring Excellence in Pharmaceutical Manufacturing
At BioTechnique®, our Quality Laboratories are committed to upholding the highest quality and compliance standards during all stages of pharmaceutical product development and manufacturing. Our expert team utilizes advanced technology to guarantee that each product fulfills rigorous regulatory standards and client expectations. BioTechnique® offers a wide array of R&D and QC laboratory testing services, utilizing the latest equipment and innovative technologies.
Key Instruments in Our Quality Laboratories
Analytical Capabilities
HPLC/UPLC Analysis
FTIR
pH
Conductivity
TOC
Karl Fisher
Osmometer
UV/Vis
Microbiology Capabilities
Endotoxin
Bioburden
SKAN Isolators – Sterility
Biological Safety Cabinet
MALDI – TOF Microbial Identification
Lyo Product Development
Lab-scale Lyophilization
Freeze Drying Microscope
Micropress Analysis
Differential Scanning Calorimeter
Electronic Quality Management Systems
BioTechnique® uses ACE®, our eQMS system that creates and tracks records, documents, and dynamic reports.
ACE® is a trusted, industry-leading, cloud-native quality management software with particular specialization in meeting the needs of pharmaceutical, medical device, and other highly regulated industries.
- Controlled Document Management
- Gap Assessment
- Receiving and Inventory Control
- Training Management
- Internal Audits and Supplier Audits
- QC Sampling and Testing
- Change Control Management
- Deviation and Non-Conformance Management
- Corrective and Preventive Action (CAPA) Program
- Environmental Monitoring and Control
- Equipment Qualification, Calibration and Maintenance
- Data Integrity Audits and Compliance
- Stability Testing and Shelf-Life Determination
- Regulatory Compliance