Pre-Approval Inspection definition

Pre-Approval Inspection means an on-site inspection of the Facility by the Regulatory Authority prior to granting the Regulatory Approval for a Commercial Product as required by various Regulatory Authorities to ensure that the Manufacturing Process and the Facility meet the appropriate requirements and comply with cGMP.
Pre-Approval Inspection or “PAI” means an on-site inspection of the Facility by the Regulatory Authority prior to granting the Regulatory Approval for a Commercial Product as required by various Regulatory Authorities to ensure that the Manufacturing Process and the Facility meet the appropriate requirements and comply with cGMP.
Pre-Approval Inspection or “PAI” means an on-site inspection of a facility by a Regulatory Authority prior to granting approval of the initial BLA and MAA as well as any PAS or Type II Variation to ensure that that the applicable manufacturing process and such facility meet the appropriate requirements and comply with the regulations. As used herein, “PAS” means the supplemental application as defined and required by the FDA for significant changes to the manufacturing process described in the BLA and which will be submitted to the FDA for the licensure of a manufacturing process at the applicable facility and “Type II Variation” means the supplemental application as defined and required by the EMA for significant changes to the manufacturing process described in the marketing authorization and which will be submitted to the EMA for the licensure of a manufacturing process at the applicable facility.

Examples of Pre-Approval Inspection in a sentence

  • When applicable, the readiness for a Pre-Approval Inspection by the FDA or other regulatory agency (PAI) of GLP subcontractors is also evaluated.

  • All units seeking Pre-Approval Inspection Certification must be vacant at the time the HQS inspection occurs and must remain vacant until a Request for Tenancy Approval is submitted for the unit.

  • Pfizer shall allow the FDA and any other relevant Regulatory Authority to conduct any Pre-Approval Inspection (“PAI”) or other inspection of the area in the Facility where the Product is to be manufactured and Pfizer agrees to cooperate with the FDA and any other relevant Regulatory Authority in connection with such inspection.

  • Pre-Approval Inspection Certification status will only be accepted for tenancy approvals during the 60-day period after the unit passes HQS inspection.

  • When applicable, the readiness for a Pre-Approval Inspection by the FDA or other regulatory agency (PAI) of cGMP and GLP subcontractors is also evaluated.

  • Pre-Approval Inspection Certification status will only be accepted for tenancy approvals during the 90-day period after the unit passes HQS inspection.

  • Description: The Pre-Approval Inspection Certification process will apply to buildings with four (4) or more units located within a single structure; the pre-approval process cannot be applied to scattered site housing.

  • In this case, FDA determined that to fulfill its statutory duty, it needed to conduct a Pre-Approval Inspection of the facility where Lannett had told it that Numbrino® would be manufactured.

  • All CMOs must be audited and approved by QA and, when applicable, readiness for Pre-Approval Inspection (PAI) by the FDA or other regulatory agency is evaluated at an appropriate time during an audit.

  • Patheon will support the Pre-Approval Inspection of the FDA (“PAI”) and equivalent regulatory inspection for other jurisdictions (where applicable) and provide a copy of the resulting report.


More Definitions of Pre-Approval Inspection

Pre-Approval Inspection means an inspection of manufacturing operations, records and facilities conducted prior to approval of a new product by the FDA or by any other applicable Governmental Body having jurisdiction to approve the Facility as a cGMP facility for the manufacture of the API.
Pre-Approval Inspection means a product-specific inspection conducted in the context of a marketing application for a medicinal product at the site of manufacture to assess conformity with good manufacturing practice; such an inspection can include an assessment of:
Pre-Approval Inspection means inspection of the Facility by FDA or corresponding European representatives in conjunction with the filing of an NDA or corresponding European application which may include among other things: verifying the accuracy and completeness of the manufacturing-related information submitted in the NDA or corresponding European application; evaluating manufacturing controls upon which information provided in the NDA or corresponding European application is based; evaluating GMP compliance; and collecting samples of GMP Grade Product.
Pre-Approval Inspection means an inspection of manufacturing operations, records and facilities conducted prior to approval of a new product by the
Pre-Approval Inspection or “PAI” means an on-site inspection of a facility by a Regulatory Authority prior to granting approval of the initial BLA and MAA as well as any PAS or Type II Variation to ensure that that the applicable manufacturing process and such facility meet the appropriate requirements and comply with the regulations. As used herein, “PAS” means the supplemental application as defined and required by the FDA for significant changes to the manufacturing process described in the BLA and which will be submitted to the [*] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the SEC.
Pre-Approval Inspection or “PAI” means an on-site inspection of a facility by a Regulatory Authority prior to granting

Related to Pre-Approval Inspection

  • Initial inspection means the first on-site inspection of facilities to verify declarations submitted pursuant to Articles III, IV, V and VI and this Annex.

  • Pre-approval means written notification via a pre-approval letter to Customer that Ameren Illinois has reviewed Customer's Application and determined that the project meets the program eligibility requirements for a maximum pre-approved incentive amount if the project is completed by the estimated completion date and all final application paperwork is submitted and approved.

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • Final Inspection means the process and procedure described in UGC Section 12.1.

  • Home inspection means the on-site, physical review of the home of an applicant to assure the applicant and the home meets all health and safety requirements within these rules.

  • type-approval means the procedure whereby an approval authority certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant administrative provisions and technical requirements;

  • Lead inspection means a surface-by-surface investigation to determine the presence of lead- based paint and the provisions of a report explaining the results of the investigation.

  • External inspection means an inspection that does not involve examination of the internal surfaces of the pressure parts of the boiler.

  • Works Approval means this Works Approval numbered W5913/2015/1 and issued under the Act; and

  • Price Approval means, in any country where a Governmental Authority authorizes reimbursement for, or approves or determines pricing for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization or pricing approval or determination (as the case may be).

  • Approval Letter means the letter from WRAS to the Applicant confirming the grant of WRAS Approval in respect of a Product;

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • Study Completion means the database for the Study has been locked and all Essential Documents have been provided to the Sponsor, including a copy of the letter from the Reviewing HREC acknowledging receipt of the final report and/or closure letter from the Principal Investigator.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Initial approval means authorization to admit students and enter into contractual agreements for clinical facilities. It is granted only after an application has been submitted, reviewed and a survey visit made by the Board. No students shall be admitted to the program until the institution has received written notification that initial approval has been granted. Failure to comply will delay initial approval.

  • Due Diligence Examination shall have the meaning set forth in Section 3.2.

  • Project Completion means completion of the Redevelopment in accordance with this Agreement to the state where the whole of the Morley Shopping Centre, as so redeveloped, is capable of occupation for its intended purpose;

  • CFIUS Approval means that any of the following shall have occurred: (a) the review period under the DPA commencing on the date that a CFIUS Notice is accepted by CFIUS shall have expired and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS to the effect that such review has been concluded and that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, (b) an investigation under the DPA shall have been commenced after such review period and CFIUS shall have determined to conclude all action under the DPA without sending a report to the President of the United States, and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, or (c) CFIUS shall have sent a report to the President of the United States requesting the President’s decision and either (i) the President shall have announced a decision not to take any action to suspend or prohibit the Contemplated Transactions or, (ii) the period under the DPA during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Contemplated Transactions shall have expired without any such action being threatened, announced or taken.

  • Approval means the written consent of the Authority.

  • Final Approval Hearing means the hearing to be conducted by the Court to determine the fairness, adequacy, and reasonableness of the Settlement pursuant to Federal Rule of Civil Procedure 23 and whether to issue the Final Approval Order and Judgment.

  • Contracting Body Satisfaction Survey shall have the meaning set out in Clause 18.1;

  • Requisite Approval means the affirmative vote of the holders of (a) at least a majority of the outstanding shares of Company Capital Stock, voting together as a single class and (b) at least a majority of the outstanding shares of Series A-1 Preferred Stock, Series B Preferred Stock and Series C Preferred Stock, voting together as a single class on an as-converted basis.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Inspections has the meaning set forth in Section 4.1.2.

  • Surveys has the meaning set forth in Section 4(o) above.

  • Study Site means the location(s) under the control of the Institution where the Study is actually conducted as set out in Schedule 1.