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In celebration of World Quality Month, members of the InstantGMP team
wrote short pieces on what quality means to them. This first post was written by
our President, Dr. Rick Soltero.
Quality has a simple definition: Meeting Specifications. Setting and meeting specifications is a little more involved. In order for your products to meet specifications consistently, you must have a quality system in place. The foundation of a quality system is its Standard Operating Procedures.
The quality system for operating under Good Manufacturing Practices (GMP) is rooted in its Standard Operating Procedures (SOPs) and corporate policies. These procedures and policies provide the instructions for managing a facility and its personnel. They describe how products are to be produced. Following SOPs is the guaranteed way of assuring each product that leaves the factory is a quality product every time.
SOPs on “Standard Operating Procedures”, “Document Management System” and “Documentation Practices” describe how the quality system SOPs will be written and managed. These are usually written first so that all SOPs that follow are consistent in their format and structure.
After the documentation standards are set, Material SOPs can be written. These describe the ordering, receipt, handling and storage of the ingredients and components that will be used in manufacturing the products. Understanding and following these procedures is important in assuring that products are made with materials that are suitable for production. This where specifications come into play.
Specifications describe the characteristics and attributes of each ingredient and component used in manufacturing the final product. They also describe the final product. Tests are chosen to challenge the ingredient’s attributes in a way that allows the product to be made consistently. Specifications are also assigned to any control point in the manufacturing process that could have an impact the final product’s purity, composition, potency and freedom from contamination. Final product testing is the last step that assures that all the ingredients and the manufacturing steps combined resulted in the product with the desired characteristics.
Producing a quality product is based on the specifications that determine what quality really means for the product. Specifications are based on the choice of tests and controls that are used for ingredients and manufacturing. Standard Operating Procedures assure that ingredients are purchased, stored and handled correctly, facilities and equipment are kept in proper order and that manufacturing is done to a set of standards that can produce a consistent product. All these functions that operate under a Quality System that is in compliance with Good Manufacturing Practices are your customers assurance that they will be getting products they can trust.