Active Pharmaceutical Ingredient. (API) Specifications shall mean the Bulk Formulated Drug Substance Specifications and requirements contained in or made a part of Company’s ANDA/NDA or other regulatory filing for territory.
Active Pharmaceutical Ingredient. (API) — Any API or mixture of APIs, intended to be used in the manufacture of a drug (or: medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such APIs 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 or any function of the body of man or animals. Business day — Any day of the week, other than Saturday, Sunday, or day on which the party required to take action is regularly closed for business, i.e., Monday to Friday (European working hours) except any official national or regional bank holidays or shut down of the plant. CEP — A certificate issued by the European Directorate for the Quality of Medicines which demonstrates that the Product complies with the requirements of the European Pharmacopoeia monograph and / or Transmissible Spongiform Encephalopathy (TSE) requirements. Also known as “CoS” = Certificate of Suitability. Certificate of Analysis — A document identified as such, provided by the Supplier signed by its Responsible Person, or produced by a computer system which provides a degree of control equivalent to that given by a signature, which sets forth the analytical test results, obtained from testing of a representative sample, against the specifications for the batch to be delivered. Certificate of Conformance — A document identified as such, provided by the Supplier and signed by a nominated representative of its Quality Unit; or produced by a computer system which provides a degree of control equivalent to that given by a signature, which certifies that each batch of Product was produced and -tested in compliance with the agreed specifications, cGMP, and the relevant pharmacopoeial monographs, as applicable. Contract — Business agreement for supply of goods or performance of work at a specified price. Contract Manufacture — Performance of some aspect of manufacture, under a contract, on behalf of the original manufacturer.
Active Pharmaceutical Ingredient. (API),—Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the Drug Product as defined in ICH Q 7. Such substances are intended to furnish pharmacological activity or other direct effect on the diagnosis, cure mitigation, treatment, or prevention of disease or to affect the structure and function of the body.
Active Pharmaceutical Ingredient. “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. “Active Pharmaceutical Ingredient” or “API” shall mean bulk Vancomycin Hydrochloride.
Active Pharmaceutical Ingredient. Halsxx xxxll use as the active pharmaceutical ingredient [___________________] as instructed by Watsxx xxx may be either such ingredient manufactured by Halsxx xx supplied by a third party.
Active Pharmaceutical Ingredient. Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that when used in the production of a drug becomes active ingredient of the Finished Animal 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 of animals.
Active Pharmaceutical Ingredient cGMP: Current Good Manufacturing Practice. ICH: International Conference on Harmonization. Certificate of Analysis: A compilation of the analytical test methods applied, specifications for each test and test results for a particular intermediate/finished API lot. The certificate should be reviewed and approved by QA management. Certificate of Conformance: Certification confirming that an intermediate or finished API has been manufactured in compliance to the cGMP’s and that quality records associated have been reviewed and approved by QA management. Commercial Agreement: the Agreement effective 21 January 2005 for the manufacture of the API by and between Avecia and Nuvelo. Approved Suppliers: Suppliers approved within Avecia’s quality system and qualified using FDA/EU guidelines, and approved by Nuvelo. Key Suppliers: Suppliers that supply key ingredients for the manufacture of the API. Change to these Suppliers would impact the API quality. OOS: Out of Specification. OOT: Out of Trend. NIST: National Institute of Standards. In-Process Control: Checks performed during production to monitor and if appropriate, to adjust the process and/or to ensure that the API conforms to the specifications attached to the QA Agreement as Appendix 6. Critical Non-conformance: A non-conformance which would impact API quality. Major Non-conformance: A non-conformance which has a potential to impact API quality and requires an investigation to assess the impact on API quality. Minor Non-conformance: A non-conformance which has no impact on API quality Reprocess: Reprocess is defined as repeat processing of a manufacturing step that does not affect the disposition of the API. For example: a 0.22 micron filtration when the filter integrity failed.
Active Pharmaceutical Ingredient. Patheon shall not be responsible for any loss or damage to the API, except where such loss or damage occurs while such ingredient is located at the Facility and results from a failure by Patheon to carry out the manufacturing activities in accordance with the Manufacturing Requirements or is otherwise due to Patheon's gross negligence or intentional misconduct. [****].
Active Pharmaceutical Ingredient. Only Horizon shall arrange or contract with supplier(s) of Glycopyrrolate to supply Glycopyrro-late for the manufacture of the Product. Mikart shall purchase such Glycopyrrolate from such supplier(s) only pursuant to such contract or arrangement and on behalf of Horizon.
