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.
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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.
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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.

  • 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.

  • 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.

  • However, as explained above, a SNT is not always required, and the determina- tion of whether a SNT is appropriate depends on whether the disabled person is receiving, or is expected to receive, means-tested government benefits.

Related to Certificate of Manufacturing Compliance

  • Certificate of Compliance means the certificate referred to in Section 3.03 of the Servicing Agreement and substantially in the form of Exhibit E to the Servicing Agreement.

  • 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.

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • 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 has the meaning set forth in Section 4.2.

  • cGMPs means, as applicable, current good manufacturing practices as described in:

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

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • 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 means current good manufacturing practices, as set forth in 21 C.F.R. Parts 210 and 211.

  • 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 all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • 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 a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • 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.

  • Manufacturing Agreement has the meaning set forth in Section 4.3.

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Non-Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.