Starting Material definition

Starting Material means any substance of defined quality used in the production of a pharmaceutical product, but excluding packing materials;

Starting Material means un-patterned epitaxial silicon wafers comprising either N-epi on an N++ Substrate or P-epi on a P++ Substrate, as applicable. Epitaxial doping and thickness vary with Process Type.

Starting Material means a sub- stance used to synthesize or purify a technical grade of active ingredient (or the practical equivalent of the tech- nical grade ingredient if the technical grade cannot be isolated) by chemical reaction.

Examples of Starting Material in a sentence

• An API Starting Material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house.

• Table 1 gives guidance on the point at which the API Starting Material is normally introduced into the process.From this point on, appropriate GMP as defined in this Guide should be applied to these intermediate and/or API manufacturing steps.

• An Active Substance Starting Material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house.

• Where the API Starting Material is a commercial molecule the requirement to provide these details (if needed for confidentiality reasons: directly to the authorities only) may be included in the commercial contract.

• Request by the QP(s) or Responsible Person(s) of the Manufacturing Authorisation Holder(s): Third Party Audit of API Starting Material used in Medicinal ProductsRequest by the API Manufacturer / Distributor / Broker/ Importer/ Packer / Re-Packer: Self Assessment Audit of GMP status ACI = API Compliance InstituteAuditee = API Manufacturer / Distributor / Broker/ Importer/ Packer / Re-PackerQP = Qualified PersonManuf.Auth.Holder = Manufacturing Authorisation Holder for Human or Veterinary Medicinal Products.

More Definitions of Starting Material

Starting Material means the raw material necessary to formulate and package the Product as set forth in Schedule A hereto (but excluding the Active Drug Substance and magnesium silicate Compressil(R) (hereinafter Compressil)).

Starting Material means certain interactive raw material (including without limitation, compressil) necessary to formulate and package the Product to be acquired directly CIRCA, as set forth in Schedule A hereto.

Starting Material means any material from which an active substance is manufactured or extracted;

Starting Material means the Substance and any other material used in the production of Finished Product, but excluding Packaging Components.

Starting Material means substances used in the manufacturing process as substrate and/or buffering agent for the production process of the MASAM;

Starting Material means the vials of [***] working cell banks.

Starting Material means any substance used in the production of a pharmaceutical product but excluding packaging materials;