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Quality AssuranceLonza Custom Manufacturing operates process oriented quality management systems based upon the international quality standard ISO9001, certified where necessary by independent official institutions. Every one of our Custom Manufacturing sites has a quality function in place, independent of production, responsible for assuring that our products are of the quality required for their intended use and that quality management systems are maintained.
Good Manufacturing Practice Lonza Custom Manufacturing is fully committed to ensuring that our global manufacturing sites comply with international regulations for current Good Manufacturing Practice (cGMP).
Inspection HistoryOur sites are routinely inspected by the FDA and other national health agencies to enable our products to be used by our customers in the United States, Europe, Japan, and many other regulated markets.
Notification of New ChemicalsMost industrialized countries have complex legislation requiring notification of new chemical and biological substances. Lonza has extensive experience and knowledge of the regulatory requirements and notification procedures in many countries. We have submitted numerous notification dossiers, especially to Unites States and European Union-competent authorities. We offer full assistance in developing safety data up to the preparation and submission of a notification dossier.
Drug Master Files (DMF's) and Biologic License Applications (BLA's)The United States Food and Drug Administration (FDA) has inspected all Lonza Custom Manufacturing production sites. Lonza has broad experience in submitting DMF's for chemical intermediates and active ingredients and BLA's for biologic products. Lonza strictly adheres to the regulations associated with the development of every new pharmaceutical ingredient, biologic product or chemical entity.
Site Master Files have been registered for all relevant Lonza production sites. Lonza Custom Manufacturing has substantial experience in submitting type II DMF's to the U.S. FDA and E-DMF's to other national regulatory authorities in Europe, Canada and Australia among others.