GMP Audit definition

GMP Audit is defined in Section 4.4(a).
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GMP Audit shall have the meaning set forth in Section 5.9(a).
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GMP Audit means: in relation to an Applicant, an inspection of the premises, equipment, processes and facilities proposed to be used by the Applicant in the manufacture of chemical products and to inspect other goods on those premises; in relation to a Licensee, an audit of the facilities, equipment, systems, processes, procedures and personnel used or proposed to be used by the Licensee in the manufacture of chemical products, to ascertain the level of compliance with the Manufacturing Principles; and in relation to an overseas facility, an audit of the facilities, equipment, systems, processes, procedures and personnel used or proposed to be used in the manufacture of chemical products, to ascertain the level of compliance with the conditions of product registration.
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Examples of GMP Audit in a sentence

  • Thus, when applicable, applicants must also submit the application form to request for GMP Evidence Evaluation or for an Overseas GMP Audit with the required documents to the Therapeutic Products Branch (as part of the product registration application) as stipulated in the Guidance Notes on GMP Conformity Assessment of an Overseas Manufacturer.

  • Non-conformances should be accurately classified and written in such a way that the next auditor can accurately identify what the problem was and which documents, procedures, activities were assessed – refer to GMP Audit Procedure – Annex B for guidance.

  • Additional reference information can be found in the IPEC-PQG GMP Audit Guideline for Pharmaceutical Excipients.

  • It also outlines the priority actions to be undertaken to achieve the goals and objectives and the measures that will be used to assess the success of the strategy.

  • The UL Technical Audits Program includes the following 8 core modules:• Quality Management System (QMS)• Facilities• Supply Management• Equipment Control and Maintenance• Contamination Control• Production Set Up• Product Conformity• Administration and Training• Hazard and Risk Management System UL Good Manufacturing Practice (GMP) Audit This GMP audit is conducted by UL.

  • If applicable, either the GMP Documentary Evidence Verification Application or Overseas GMP Audit application should be submitted for manufacturing sites which are new to Singapore.

  • Roche will perform a formal GMP Audit after the completion of PQ by PDL.

  • Client’s costs associated with attending and conducting each GMP Audit shall be at Client’s cost.

  • If PDL, based upon the Licensed Product demand forecasts, decides to expand the capacity of its 610 Manufacturing Facility to supply Licensed Product, then Roche shall have the right, but not the obligation to perform both an informal audit and a formal GMP Audit of such capacity expansion.

  • A third party GMP Audit will generally be much more intensive than a regulatory inspection, but less intensive than a GFSI Audit.A GFSI Audit will require additional food safety programs not required by a GMP Audit, is muchmore document intensive and includes more focus on checking that you “do what you say you do” on the production floor.


More Definitions of GMP Audit

GMP Audit has the meaning in Section 13(a) of Attachment A.
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GMP Audit means an audit carried out by a TGA GMP Auditor/s of manufacturers of Veterinary Medicines and human therapeutic goods;
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GMP Audit means an assessment of (i) Oculex's and/or any Third-Party Supplier's (as defined herein) compliance with Good Manufacturing Practice for Pharmaceuticals: General, as set forth in Title 00 Xxxxxx Xxxxxx Code of Federal Regulations, Part 211, and elsewhere, as well as any applicable similar laws or regulations of any relevant foreign governments, general industry practices and (ii) the effectiveness of Oculex's and/or any such Third-Party Supplier's quality assurance programs in effect at the time concerned.
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Related to GMP Audit

  • Audit means the examination of a person or the inspection of the books, records, memoranda, or accounts of a person, ordered to appear before the Tax Administrator, for the purpose of determining liability for a municipal income tax.

  • Neutral Auditor means Ernst & Young or, if Ernst & Young is unable to serve, an impartial nationally recognized firm of independent certified public accountants other than Seller’s accountants or Purchaser’s accountants, mutually agreed to by Purchaser and Seller.

  • Initial Audit is Bank’s inspection of Borrower’s Accounts, the Collateral, and Borrower’s Books, with results satisfactory to Bank in its sole and absolute discretion.

  • Approved Auditor means a person who is:

  • Compliance Audit means the procedure (in a form advised by the GLA from time to time) by which an auditor independent of the Grant Recipient certifies (at the Grant Recipient's cost) whether the Named Projects developed or Rehabilitated pursuant to this Agreement satisfy the GLA's procedural compliance requirements (as described in the Affordable Housing Capital Funding Guide);

  • Energy audit means a systematic procedure with the purpose of obtaining adequate knowledge of the existing energy consumption profile of a building or group of buildings, an industrial or commercial operation or installation or a private or public service, identifying and quantifying cost-effective energy savings opportunities, and reporting the findings;

  • conformity assessment body means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

  • Independent Auditor has the meaning specified in Section 6.01(a).

  • Annual Accountant’s Report is defined in Section 3.04(a) of the Servicing Agreement.

  • Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who has 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.

  • Independent testing laboratory means an independent organization, accepted by the Contracting Officer, engaged to perform specific inspections or tests of the work, either at the site or elsewhere, and report the results of these inspections or tests.

  • Appraisal review means the act or process of developing

  • County Auditor means the Greenville County Auditor, or the person holding any successor office of the County.

  • Root Cause Analysis Report means a report addressing a problem or non-conformance, in order to get to the ‘root cause’ of the problem, which thereby assists in correcting or eliminating the cause, and prevent the problem from recurring.

  • cost accountant means a cost accountant as defined in clause (b) of sub-section (1) of section 2 of the Cost and Works Accountants Act, 1959 (23 of 1959) and who has obtained a certificate of practice under sub-section (1) of section 6 of that Act;

  • non-audit services means services other than audit services.

  • Independent Auditors has the meaning set forth in Section 3.2.

  • 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.

  • Independent Engineering Report means a report, in form and substance satisfactory to the Administrative Agent and each of the Lenders, prepared by an Independent Engineer, addressed to the Administrative Agent and the Lenders with respect to the Oil and Gas Properties owned by the Borrower or its Subsidiaries (or to be acquired by the Borrower or any of its Subsidiaries, as applicable) which are or are to be included in the Borrowing Base, which report shall (a) specify the location, quantity, and type of the estimated Proven Reserves attributable to such Oil and Gas Properties, (b) contain a projection of the rate of production of such Oil and Gas Properties, (c) contain an estimate of the net operating revenues to be derived from the production and sale of Hydrocarbons from such Proven Reserves based on product price and cost escalation assumptions specified by the Administrative Agent and the Lenders, and (d) contain such other information as is customarily obtained from and provided in such reports or is otherwise reasonably requested by the Administrative Agent or any Lender.

  • Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.

  • Expedited review means an examination, in accordance with

  • Practical examination means a demonstration through application of the safety rules and principles in industrial radiography including use of all procedures and equipment to be used by radiographic personnel.

  • the Auditors means the auditors from time to time of the company or, in the case of joint auditors, any one of them;

  • Clinical experience means providing direct services to individuals with mental illness or the provision of direct geriatric services or special education services. Experience may include supervised internships, practicums, and field experience.

  • Auditor means the person for the time being performing the duties of auditor of the Company (if any).