Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
Outsourcing Stability Studies to Contract Laboratories
Ensuring that a stability study is done correctly and meets a pharmaceutical company's needs requires a great deal of teamwork and clear communication. The most crucial of these is communication, which establishes everything from the testing to be conducted to how samples should be handled, stored and transported. Clear communication is also important for protocol, labeling, timing and packaging.
Pharmaceutical companies must establish basic testing protocols from the start and communicate them clearly. This includes requirements, methods, quantities, spares storage, time points for pulling samples, the pull window and any changes over the course of the study.
Other practical considerations to make and communicate include:
The perfect stability study protocol includes full information about all samples, how to treat and transport the samples and details on testing. Instruction should include definitions, assignments, requirements and necessary information. Communicate these concerns, along with practical considerations and basic protocols to ensure a successful collaboration. For more detailed insights on successful collaboration, download our free white paper.
Glenn Graves brings more than 20 years of experience in analytical chemistry and pharmaceutical analysis, specializing in chromatography, spectroscopy, and thermal analysis. Throughout his career, he has obtained expertise in a wide variety of analytical techniques including total organic carbon analysis, ion chromatography, and optical rotation. As Managing Director of the Intertek Whitehouse, NJ facility, Glenn leads the agreement and implementation of laboratory policy and protocols, regulatory compliance (including FDA, cGMP/cGLP, DEA, and OSHA requirements) and health and safety. In addition, he oversees the preparation and completion of action plans pertaining to laboratory and regulatory corrective actions and preventative actions (CAPA).