Certificate of cGMP Compliance definition

Certificate of cGMP Compliance means, for each clinical Batch and each Batch produced for stability testing, a document prepared by CPL in form and substance reasonably satisfactory to Helix:
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Certificate of cGMP Compliance means a document, signed by an authorized representative of JULPHAR, certifying that the Active Ingredient being delivered to DANCE has been manufactured in conformity with cGMPs.
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Certificate of cGMP Compliance means a document, signed by an authorized representative of SAD, certifying that the Active Ingredient being delivered to Buyer has been manufactured in conformity with cGMPs.
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Examples of Certificate of cGMP Compliance in a sentence

  • BioVectra shall include the following for each shipment of Product: (a) the Purchase Order number; (b) the lot and batch numbers; (c) the quantity of Product; and (d) the Certificate of cGMP Compliance.

  • The Active Ingredient will be shipped with the requisite packing slip, Certificates of Analysis and Certificate of cGMP Compliance.

  • CPL shall include the following for each shipment of Product: (a) the purchase order number; (b) the lot and batch numbers; (c) the quantity of Product; and (d) the Certificate of cGMP Compliance.

  • No Active Ingredient shall be released to DANCE without a Certificate of Analysis and Certificate of cGMP Compliance, both of which shall be supplied to DANCE by JULPHAR, (a) stating that the Active Ingredient being shipped have been tested and conforms to the Specifications and Quality Control Requirements, (b) confirming compliance with cGMP, the FD&C Act and all other Applicable Laws, rules and regulations.

  • No Active Ingredient shall be released to Buyer without a Certificate of Analysis and Certificate of cGMP Compliance, both of which shall be supplied to Buyer by SAD.

  • No Active Pharmaceutical Ingredient shall be released to Company without a Certificate of Analysis and Certificate of cGMP Compliance, both of which shall be supplied to Company by Interquim, (a) stating that the Active Pharmaceutical Ingredient being shipped has been tested and conforms to the Specifications and Quality Control Requirements, (b) confirming compliance with cGMP, the FD&C Act and all other Applicable Laws, rules, and regulations.

  • No Active Ingredient shall be released to DANCE without a Certificate of Analysis and Certificate of cGMP Compliance, both of which shall be supplied to DANCE by DONGBAO, (a) stating that the Active Ingredient being shipped have been tested and conforms to the Specifications and Quality Control Requirements, (b) confirming compliance with cGMP, the FD&C Act and all other Applicable Laws, rules and regulations.

  • Hence, the response action is determined to be com- pleted when the average airborne asbestos concentration measured inside the abate- ment area is not statistically different from the average airborne asbestos concentration measured outside the abatement area.

  • No PUMPS shall be released to DANCE without a Certificate of Analysis and Certificate of cGMP Compliance, both of which shall be supplied to DANCE by AERO PUMP, (a) stating that the PUMPS being shipped have been tested and conforms to the Specifications and Quality Control Requirements, (b) confirming compliance with cGMP, the FD&C Act, other applicable rules and regulations.

  • The PUMPS will be shipped with the requisite packing slip, Certificates of Analysis and Certificate of cGMP Compliance.

Related to Certificate of cGMP 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.

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

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

  • Certificate of inspection means an unsworn statement,

  • Certificate of Final Completion means the certificate issued by A/E that documents, to the best of A/E’s knowledge and understanding, Contractor’s completion of all Contractor’s Punchlist items and pre-final Punchlist items, final cleanup and Contractor’s provision of Record Documents, operations and maintenance manuals, and all other closeout documents required by the Contract Documents.

  • certificate of fitness means a certificate issued by the Department to a contract bus carrier.

  • Certificate of Coverage means a written certification provided by any source that offers medical care coverage, including the Plan, for the purpose of confirming the duration and type of an individual’s previous coverage.

  • 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/

  • Certificate of approval means a certificate of approval obtained from the

  • Certificate of origin means the document provided by the manufacturer of a new motor vehicle, or

  • Certificate of Insurance means a document showing that an insurance policy has been written and includes a statement of the coverage of the policy.

  • certificate of competency means a certificate issued by the Washington state board of boiler rules to a person who has passed the tests as set forth in WAC 296-104-050.

  • Certificate of organization means the certificate required by section 489.201. The term includes the certificate as amended or restated.

  • Statement of Compliance means the statement forming part of a Tender indicating the Bidders compliance with the Specification.

  • Certificate of Appropriateness means the written approval of a permit application for work that is appropriate and that does not adversely affect a resource.

  • Medical certificate of fitness means a certificate valid for one year issued by an occupational health practitioner, issued in terms of these regulations, whom shall be registered with the Health Professions Council of South Africa;

  • Annual Statement of Compliance As defined in Section 3.13.

  • 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.

  • Certificate of Substantial Completion means the certificate executed by the A/E, ODR and Contractor that documents to the best of A/E’s and ODR’s knowledge and understanding, Contractor’s sufficient completion of the work in accordance with the Contract, so as to be operational and fit for the use intended.

  • Compliance Declaration means a compliance declaration substantially in the form set out in Schedule F;

  • Certificate of Limited Partnership means the Certificate of Limited Partnership of the Partnership filed with the Secretary of State of the State of Delaware as referenced in Section 7.2, as such Certificate of Limited Partnership may be amended, supplemented or restated from time to time.

  • Certificate of Conversion means the Certificate of Conversion to Limited Liability Company of the Corporation to the Company as filed in the office of the Secretary of State of the State of Delaware pursuant to the Delaware Act.

  • Covenant Compliance Certificate means a properly completed and executed Covenant Compliance Certificate substantially in the form of Exhibit X hereto.

  • certificate of registration means registration with the College that allows the Participant to practise medicine in British Columbia, other than the certificate of registration which allowed the Participant to enrol in Postgraduate Medical Education;

  • Assessment of Compliance As defined in Section 3.21.