Certificate of Manufacturing Compliance definition

Certificate of Manufacturing Compliance means a document signed by an authorized representative of Laureate, attesting that a particular Batch was manufactured, filled, packaged, held and shipped in accordance with applicable Good Manufacturing Practices, the Specifications and all other applicable laws, rules and regulations.
Certificate of Manufacturing Compliance means, as the case may be, a document, signed by an authorized representative of the Quality Unit of (i) ARIAD or its Approved Manufacturer, attesting that a particular Lot of Clinical Product (prior to Clinical Product Transfer) (including the API incorporated therein) or Batch of API, or (ii) MERCK or its Approved Manufacturer, attesting that a particular Lot of Clinical Product (after Clinical Product Transfer) or Marketed Product, in each case (clauses (i) or (ii)) was Manufactured in accordance with the Specified Regulatory Requirements.
Certificate of Manufacturing Compliance means a document, signed by an authorized representative of ARIAD or its licensee or Third Party manufacturer, attesting that a particular Batch of API was manufactured, filled, packaged, held and shipped in accordance with applicable cGMPs, and all other applicable laws, rules, regulations or requirements of the countries listed on Appendix A.

Examples of Certificate of Manufacturing Compliance in a sentence

  • Each Delivery of Clinical Product, Marketed Product or API shall be accompanied by a Certificate of Analysis and a Certificate of Manufacturing Compliance, if required by applicable law, pertaining to the Clinical Product, Marketed Product or API in such shipment.

  • ARIAD is responsible for providing, in support of MERCK’s responsibility for the final release decision or acceptance of API, a copy of all Manufacturing records required by MERCK to accept API and release MERCK Product, including but not limited to a Certificate of Manufacturing Compliance, Certificate of Analysis, Batch Records and information as further specified in the Quality Agreement, for each Batch of API Manufactured hereunder.

  • Upon delivery of each shipment of the API, ARIAD shall promptly invoice MEDINOL therefor, and shall include in such invoice a Certificate of Analysis and a Certificate of Manufacturing Compliance pertaining to the API in such shipment.

  • MERCK is responsible for providing, in support of ARIAD’s responsibility for its final release decision, a copy of all Manufacturing records required by ARIAD to release Marketed Product, including but not limited to, a Certificate of Manufacturing Compliance, Certificate of Analysis, Batch Records and information as further specified in the Quality Agreement, for each Lot of Marketed Product Manufactured hereunder.

Related to Certificate of Manufacturing Compliance

  • Certificate of Compliance means a certificate issued in terms of the Regulations in respect of an electrical installation or part of an electrical installation by an accredited person;

  • Certificate of Conformance means a document issued by the NCWM based on testing by a participating laboratory that constitutes evidence of conformance of a type.

  • Date of manufacture means the date on which the food becomes the product as described;

  • cGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

  • Certificate of noncompliance means a document known as a certificate of noncompliance which is provided by the centralized collection unit of the department of revenue certifying that the named applicant or licensee has an outstanding liability placed with the unit and has not entered into an approved payment plan to pay the liability.

  • Certificate of Continuing Program Compliance means the Certificate to be filed by the Owner with the Administrator, on behalf of the Issuer, and the Trustee pursuant to Section 4(f) hereof, which shall be substantially in the form attached as Exhibit C hereto or in such other comparable form as may be provided by the Issuer to the Owner, or as otherwise approved by the Issuer.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Drug Substance means an active ingredient 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 human body, but does not include intermediates used in the synthesis of such ingredient.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Certificate of Analysis means a document signed by an authorized representative of Manufacturer, describing Specifications for, and testing methods applied to, Product, and the results of testing.

  • Clinical Supply Agreement shall have the meaning set forth in Section 7.2.

  • cGMPs means current good manufacturing practices as described in Parts 210 and 211 of Title 21 of the United States’ Code of Federal Regulations, together with the latest FDA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time;

  • Certificate of Conformity means Executive Order certifying vehicles for sale in California.

  • Manufacturing Site means a location where a manufacturing

  • Certificate of Catholic Practice means a certificate issued by the family’s parish priest (or the priest in charge of the church where the family attends Mass) in the form laid down by the Bishops’ Conference of England and Wales. It will be issued if the priest is satisfied that at least one Catholic parent or carer (along with the child, if he or she is over seven years old) have (except when it was impossible to do so) attended Mass on Sundays and holy days of obligation for at least five years (or, in the case of the child, since the age of seven, if shorter). It will also be issued when the practice has been continuous since being received into the Church if that occurred less than five years ago. It is expected that most Certificates will be issued on the basis of attendance. A Certificate may also be issued by the priest when attendance is interrupted by exceptional circumstances which excuse from the obligation to attend on that occasion or occasions. Further details of these circumstances can be found in the guidance issued to priests http://rcdow.org.uk/education/governors/admissions/

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • Good Manufacturing Practices or “GMP” shall mean the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant Governmental Authority having jurisdiction over the development, manufacture or sale of the Product in the Territory pursuant to its regulations, guidelines or otherwise.

  • Place of manufacture means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

  • Good Manufacturing Practice or “GMP” means the current good manufacturing practices applicable from time to time to the manufacturing of a Product or any intermediate thereof pursuant to Applicable Law.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Certificate of Completion means the certificate of completion given by the Engineer-in- charge pursuant to clause 40 of these conditions;

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.