Marietta Corporation utilizes a Quality Systems approach to ensure its compliance with regulations and customer requirements. Elements of Marietta’s Quality Systems include:
- Corporate Quality Standards – these Corporate Policies are approved by the executive team at Marietta, including the CEO. They define the standard expectations that all Marietta sites must meet with respect to quality and compliance.
- SOP’s – A complete set of Standard Operating Procedures are in place at each site, using the Marietta Quality Standards as its basis, but written specifically to match the technologies and product types at each facility.
- Lot Control – all materials that are used in specific quantities are received, tested, released, and dispensed according to specific lot numbers. This allows for full control of materials, and traceability if a quality investigation is needed. We understand the status of our raw materials, components, work-in-process, and finished products at all times.
- Quality Control – Each of Marietta’s production sites contain analytical chemistry laboratories which provide site-specific raw material, packaging component, bulk product, and finished product testing as required by our customers’ specifications. Microbiological laboratories exist at our Cortland and Los Angeles sites, and are currently being added to our Chicago facility, to provide a high level of material control and ensure appropriate environmental monitoring of our facilities.
- Method Development, Validation, and Transfer – Marietta has a Method Development, Validation and Transfer organization which can both develop new or transfer existing analytical methods, based on customer needs, and ensure that those methods are validated according to regulatory expectations.
- Stability – Marietta Corporation writes Stability protocols and conducts Stability testing for its customers. In the early stages of a project, these same capabilities are used to provide Material Compatibility data during the early formula and package development phases.
- Validation – Marietta Corporation has a Validation Department that provides Equipment Qualification, Computer System Validation, Process Validation and Cleaning Validation support for all sites.
- Change Control – Change Control boards at each location consider product, process, and equipment changes for the impact of such changes to the validated state of the customer’s product. The Quality Assurance department leads the Change Control efforts at each site.
- Corrective and Preventative Action (CAPA) Program and Trend Analysis – one of the most important elements of a strong Quality System is a robust CAPA program, where actions to solve and prevent recurrence of problems are developed and documented, and developing trends can be analyzed and rectified before they become larger issues that can affect Supply Assurance. Marietta systematically tracks and trends its CAPA’s, and this trend analysis is shared with its Executive Management at quarterly “Quality Summits” attended by Production and Quality Management from each production site. The effectiveness of prior, closed CAPA’s are evaluated and monitored at these Summits.
- Quality Agreements – clear communication and transparency are key to Marietta and its relationship with its customers. To help ensure clear communication and eliminate confusion in roles and responsibilities, Marietta routinely develops Quality Agreements with its customers. These agreements outline quality system expectations and responsibilities between Marietta and our customer, which streamlines communications and ensures that all compliance expectations are met.
- Site Master Files – for products manufactured for shipment outside the US, Marietta’s Regulatory Department maintains and can provide its customers with Site Master Files for each Marietta location. This allows our customers to successfully file Marietta as the manufacturer of record in its international filings.
- Supplier Qualification – in cases where Marietta purchases materials, suppliers of these materials are evaluated and qualified using Marietta’s Supplier Qualification program. This program ensures that all suppliers meet the quality standards of Marietta and our customers, ensuring continuous reliability of supply.