Case Study Strides

Strides Pharma Science Limited is a global pharmaceutical company that engages in developing, manufacturing, and marketing pharma products for emerging and regulated markets. The company manufactures a wide range of technically complex and niche pharmaceutical products. Strides ranks among the world’s top 5 soft gelatin capsule manufacturers. It has an edge in the production of oral solids, soft-gel capsules (SGC), topicals, modified releases, and liquids.

Adherence to Quality Standards & Regulatory Guidelines

Quality interventions at Strides are supported by a sophisticated IT-driven platform that has enabled the implementation of advanced quality standards across manufacturing facilities. With digitalization at the core of futuristic company goals, Strides is also progressively adapting to the automation of its manufacturing processes. Maintaining an electronic logbook is one of the most essential elements of effective quality management. It is a mandatory requirement as per FDA 21 CFR 211.182 equipment cleaning and use log requirements.

Challenges Faced due to Limited Functionality

Strides, one of the largest pharmaceutical manufacturing companies globally, must meet huge market demands within stringent timelines. Adhering to regulatory compliances is mandatory. While complying with the industry GMP guidelines and monitoring every stage of batch production, Strides faced certain pitfalls in its existing system. There were no cleaning controls for the area and equipment used in the manufacturing process. The businesses’ manufacturing SOPs displayed inconsistencies. For example, a real-time business scenario such as mandatory recleaning for an area idle for 72 hours after cleaning was not covered.