Analyze Raw Materials to Improve Product Quality
Using software systems to understand raw materials impact on product outcomes
Raw materials are intrinsic to the manufacturing process and quality of all bio/pharma products – small molecule pharmaceuticals, biologics, and cell and gene therapies alike. Even minor variations in raw materials such as media, excipients, and manufacturing process agents may cause process variability, and impact product quality and patient outcomes.
A key takeaway from the FDA’s ‘Process Validation: General Principles and Practices’ guideline is the Agency’s focus on the need to detect and control process variation and understand its impact. Managing variation requires the ability to monitor and validate the quality of in-process material and drug product.
Raw Materials Management
Traditionally, raw materials management focused on sourcing, storage, safety, quantity, and quality with enterprise resource planning (ERP) and materials management software systems.
However, these systems were not designed to analyze the impact of raw materials on the manufacturing process, product quality – and patient outcomes. Material quality and performance correlate to the quality profile of the drug and its subsequent efficacy for the patient.
Skyland PIMS® process information management system is designed to centralize, organize, and analyze product, process, and patient data from paper, spreadsheets, ERPs, and other digital systems (e.g., EBR, LIMS, MES). PIMS™ enables the detailed analysis and management of traditional raw materials and personalized medicine samples in order to correlate the impact of these materials to product and patient outcomes.
