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:
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.
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.

Examples of Certificate of cGMP Compliance in a sentence

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

Related to Certificate of cGMP 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.

  • 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 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 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.

  • 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 accreditation means a certificate issued by an accrediting body to a licensed testing laboratory, entity, or site to be registered in the state.

  • 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 converting the Company’s prior partnership into the Company filed with the office of the Secretary of State of the State of Delaware on March 2, 2000.