GMP Batch Release Testing
GMP (Good Manufacturing Practice) batch release testing is a critical step in ensuring the quality, safety, and efficacy of pharmaceuticals before they are released for distribution and use. This testing is conducted in compliance with regulatory requirements by qualified personnel in a dedicated quality control laboratory.
Regulatory Compliance and Oversight
In the UK, GMP batch release testing is vital for ensuring pharmaceutical products meet quality standards before entering the market. The Medicines and Healthcare products Regulatory Agency (MHRA) oversees this process. Pharmaceutical manufacturers must adhere to GMP guidelines throughout production, which cover:
- Facility cleanliness
- Equipment maintenance
- Quality control procedures
Comprehensive GMP Testing Services at Tentamus Pharma UK
At Tentamus Pharma UK, our chemistry and microbiology labs collaborate to provide a wide range of pharmaceutical tests tailored to clients' requirements and specifications. We offer the following GMP testing services:
Chemistry Testing Services
- Assay Testing
- Dissolution Testing
- Particulate Analysis
- Residual Solvents Analysis
- Identification of Components
- Analysis of Related Substances and Impurities
- Inhaler Testing (including ACI and UDD methods)
- Physical Testing (Loss on Drying, Viscosity, Density, Osmolality, pH)
- Tablet/Capsule Testing (including disintegration, hardness, and friability)
Microbiology Testing Services
State-of-the-Art Laboratory Facilities
We operate three chemistry labs and two microbiology labs, featuring dedicated cleanroom facilities with three isolators for sterility testing. Our advanced facilities and expert personnel ensure accurate and reliable testing results.
Ensure the quality, safety, and efficacy of your pharmaceutical products with our comprehensive GMP Batch Release testing services. Contact us today to learn more about our services and how we can support your quality assurance efforts.
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