Teva CFS Book English

16 GMP- What it’s all about GMP (Good Manufacturing Practice) is a quality system that audits the manufacturing and testing layout of the pharmaceutical, food, and medical instrumentation industry (see frame on opposite page). The GMP book concentrates all the FDA procedures (see frame on next page), and defines how all the activities in a pharmaceutical plant need to be carried out, from the management level to the most entry-level worker: handling raw materials, finished products, decisions regarding raw material suppliers and their approvals, releasing and rejecting products, documenting methods, operating and approving instrumentation, testing and approving packaging materials, and more. This is a “Do’s and Don’ts” book that takes long to compile and is constantly being updated. Ester Abramovich, who managed the Teva Kfar Saba Analytic Lab for 30 years and compiled the GMP book for the lab, defines it as “the written law” instead of “the oral law”. Already at the end of the seventies, the procedural infrastructure for organized work at a pharmaceutical company was laid at the Ikapharm plant and this became validated after the plant was bought by Teva. Closing gaps At the end of the eighties and early nineties the FDA discontinued the inspections and refreshed the GMP requirements and every plant that wanted to export to the American market had to close the gaps. Uri Hillel, who served as a production pharmacist at Kfar Saba since 1991, recounts: “We started intensive work to adapt the plant to the FDA requirements. The work entailed all the domains: QA, production, equipment maintenance, buildings and facilities, handeling active and inactive ingredients, containers, stoppers, packaging, labels, warehouses, laboratories, and of course regulation and documentation. All the topics underwent comprehensive review by internal experts and external consultants on behalf of the plant. The gaps vis-a-vis existing and developing regulations were identified and a plan was devised to adapt the plant both to FDA standards and to those of other authorities”. 1992 - The plant’s moment of truth arrives Collaboration between all the units led to successfully passing the first important inspection that took place in 1992, as well as successes in numerous subsequent inspections. The inspections tested the plant to the highest resolution, from the dress code, through the door pressure gradient, preventive maintenance, equipment maintenance, and employee training. The entire plant participated in the preparation for the inspections. Uri Hillel recounts: “This was the most significant inspection, the starting line for the plant for important launches to the United States - and subsequently we started to receive approvals to market several generic products to the U.S. Everyone got on board and came prepared to the inspection. The team work was incredible. Every inspection is challenging and everyone contributed to the joint effort to show that we meet the requirements. Everyone was beyond professional and the FDA inspectors were very impressed that both managers and workers knew every cog in the wheel and every stage in the process”. Showered with compliments The inspection in 1992 lasted 3 weeks, Uri Hillel recounts: “We received a lot of compliments for the achievements during Laying Down the Foundation for Future Success The first decade after the Ikapharm plant was acquired and became Teva Kfar Saba, was dedicated to laying the professional infrastructures. The plant’s entry ticket to the global pharmaceutical market entailed complying with the-FDA requirements and implementing GMP procedures. Uri Hillel , previously the QA Manager of the Operations Division, and currently a senior VP, Quality