Active Pharmaceutical Ingredient (API Clause Samples
Active Pharmaceutical Ingredient (API. 5.2.1 INTERMUNE is responsible for providing CATALENT with API that meets SPECIFICATIONS and a CERTIFICATE OF ANALYSIS from the API vendor.
5.2.2 INTERMUNE is responsible for qualifying the API manufacturer to ensure full compliance with GMPs and APPLICABLE LAWS and will provide CATALENT with a statement of qualification for each API manufacturer.
5.2.3 CATALENT and INTERMUNE are responsible for creating and approving SPECIFICATIONS for API.
5.2.4 CATALENT is responsible for sampling, testing, and releasing each lot of API according to internal SOPs and approved SPECIFICATIONS. InterMune/Catalent - KY Quality Agreement Confidential [ * ] = Certain information on this document has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
5.2.5 CATALENT will store the API at the facilities in accordance with the API SPECIFICATIONS until manufacture of the PRODUCT.
Active Pharmaceutical Ingredient (API. “Active Pharmaceutical Ingredient” or “API” means the active pharmaceutical ingredient, sterile fosfomycin sodium. The API shall meet European Pharmacopoeia 01/2008: 1329 monograph specifications and any other specifications that may be required by the FDA for approval in the Territory.
Active Pharmaceutical Ingredient (API. 5.2.1 INTERMUNE is responsible for providing CATALENT with API that meets SPECIFICATIONS and a CERTIFICATE OF ANALYSIS from the API vendor.
5.2.2 INTERMUNE is responsible for qualifying the API manufacturer to ensure full compliance with GMPs and APPLICABLE LAWS and will provide CATALENT with a statement of qualification for each API manufacturer.
5.2.3 CATALENT and INTERMUNE are responsible for creating and approving SPECIFICATIONS for API.
5.2.4 CATALENT is responsible for sampling, testing, and releasing each lot of API according to internal SOPs and approved SPECIFICATIONS. InterMune/Catalent - KY Quality Agreement Confidential
5.2.5 CATALENT will store the API at the facilities in accordance with the API SPECIFICATIONS until manufacture of the PRODUCT.
Active Pharmaceutical Ingredient (API. Any substance intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. Also referred to as drug substance. Audit: A planned, independent, documented, objective assessment per written procedures to verify that systems and/or processes have been developed, and are currently being followed to achieve quality system objectives and/or regulatory requirements.
Active Pharmaceutical Ingredient (API any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body of humans or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.