Complete Laboratory Solutions
Pharmaceutical
Testing Services / Pharmaceutical
Microbiological and Analytical testing is crucial to ensuring the safety, quality, and regulatory compliance of pharmaceutical products. These tests detect harmful contaminants and verify the identity, purity, potency, and stability of drugs, safeguarding public health and ensuring consistent product quality. Conducting these tests in-house can be resource-intensive and complex. By outsourcing to CLS who have significant experience and advanced capabilities, pharmaceutical companies can ensure thorough, reliable testing while focusing on their core competencies. Partnering with CLS for microbiological and analytical testing not only guarantees compliance with stringent regulatory standards but also streamlines the entire drug development and manufacturing process.
Pharmaceutical Industry Testing
Microbiological
We offer a full suite of GMP microbiological testing services, with experienced sampling analysts available for on-site sampling or the collection of client-taken samples.
Routine Microbiological Testing
- Bioburden analysis
- Microscopic ID’s in supporting product and clean-room monitoring
- Bacterial yeast and mould, Malditoff and PCR analysis
- Endotoxin Testing (LAL), both gel clot and chromogenic methods available
- Absence of specific organisms
- Media fill
Environmental Monitoring Process Qualification (EMPQ)
- Microbial assessment and monitoring
- Bioburden and endotoxin assessment
- Development and validation of test methods
Stability Testing
- ICH Stability Studies
- Preservative Efficacy Testing (PE Testing)
Validation & Experimental Design Projects
CLS offers a broad range a of customized validation projects. These projects may be pre-defined and scoped by the client or developed in collaboration with CLS. Our team provides a wealth of expertise and knowledge, which can be leveraged to create and finalize tailored programs.
- Method Transfers from client sites to CLS
- Test Method Validation
- Method Development to International Guidelines
- Process Validation
- Process Simulation
- Purified Water Systems
- Cleaning / Detergent Validation
- Training / Comparative Validations
- Pilot Validation Studies
- Material Integrity Validation
Chemical & Analytical
Chemical and analytical testing services play a crucial role in the pharmaceutical industry, ensuring the safety, efficacy, and quality of pharmaceutical products. These services encompass a wide range of analytical techniques used to identify, quantify, and characterize substances, including active pharmaceutical ingredients (APIs), excipients, and finished dosage forms.
Routine Analytical Testing
- Water Testing
- Raw Material Testing
- Pharmacopoeias Testing – European, United States, BP, JP, ChP.
- Finished Product Testing
- Cleaning and Detergent Testing
- QC Release Testing
Stability Testing & Storage
- Retain sample testing and storage
Validation Projects
- Method Transfer
- Method Development
- Analytical Method Verifications
- Cleanroom Validation
Technical Consultancy
- Project based or ongoing
CLS FlexiQ
Flexible Managed Quality Services
CLS builds strategic partnerships with its clients to deliver a flexible and managed quality solution.
Flexible managed quality service (FlexiQ) provides a seamless solution by supplying organisations with highly skilled, work-ready quality professionals on a temporary, project-specific, or long-term basis.
This service can be provided at a CLS site or directly at the client's location. CLS builds strategic partnerships with its clients to deliver a flexible and managed quality solution.
ONLINE RESULTS AVAILABLE 24/7
FLEET OF REFRIGERATED VEHICLES
Managed services on client sites
Highly ACCREDITED LABORATORY
Expert Customised Technical Support
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