GMP Audit definition

GMP Audit is defined in Section 4.4(a).
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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 ▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇ 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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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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Examples of GMP Audit in a sentence

  • The GMP Audit will be successful if (a) the ▇▇ ▇▇▇▇▇, ▇▇ Reports, and Quality Management System are in compliance with cGMP guidelines and (b) there are no observations which (i) will lead to a significant delay of Phase III clinical development or the anticipated launch of the product, (ii) present a significant risk of non-acceptance of the site by regulatory authorities for clinical and/or commercial supplies, or (iii) may place clinical material or commercial supplies “at risk”.

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

  • Upon such written notice by Genentech to Corvus, Genentech (or its representatives) shall have the right to perform the GMP Audit in accordance with an audit plan (including the dates for such audit) proposed by Genentech and agreed to by the Parties.

  • Upon a written request by Genentech to BioLineRx delivered at least [*] in advance of the proposed audit dates, Genentech (or its representatives who are reasonably acceptable to BioLineRx) shall have the right to perform the GMP Audit in accordance with a written audit plan (including the mutually agreed dates for such audit) proposed by Genentech and agreed to by the Parties.

  • 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.

  • When nearing the completion of PQ, PDL should supply Roche with advance copies of their PQ procedures, plans, and other related documents, and determine, with Roche, an appropriate timeline for the GMP Audit, which allows both parties to prepare properly.

  • When nearing the completion of PQ, PDL should supply Roche with advance copies of their PQ procedures, plans, and other related documents, and determine, with Roche, an appropriate timeline for the GMP Audit, which allows both Parties to prepare properly.

  • Within [***] of a GMP Audit, Genentech shall provide a copy of the audit report to Corvus.

  • Such GMP Audit shall be conducted at Genentech’s sole expense, and Genentech’s auditing personnel will be accompanied at all times by BioLineRx personnel (or its representative who is reasonably acceptable to Genentech).

  • During a GMP Audit, Client and/or its representatives may observe, inspect, and audit the manner in which PCT conducts the Manufacturing Process; and (ii) inspect PCT’s Facility, procedures (including SOPs) and records (including Records) relating to the Services, including PCT’s quality and other controls related to the Manufacturing Process.


More Definitions of GMP Audit

GMP Audit has the meaning in Section 13(a) of Attachment A.
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GMP Audit shall have the meaning set forth in Section 5.9(a).
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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);