Product Quality Review. Where Patheon is requested by Zogenix to provide data over and above the PQR Data or where Patheon is requested by Zogenix to perform trending and critical analysis on the PQR Data, Patheon will invoice Zogenix at a rate of [***]. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. Patheon’s fee for providing audit support where more than [***] per annum at the Facility is requested by the client, as set out in Section 2.1(g), [***].
Product Quality Review. 4.13.1. GW shall provide to NOVARTIS a copy of the annual Product Quality Review (PQR) for Product(s) which summarizes manufacturing history, test results, deviations, change control, information on quality, validation, trending, corrective and preventative actions (CAPA(s)), process capability, conclusions and other items related to the manufacture of Product(s).
4.13.2. Any sub-contracted activity shall be included into the PQR.
4.13.3. The PQR shall be provided to NOVARTIS according to the defined date in the agreed GW format.
4.13.4. GW will prepare the PQR report to include all items detailed in EU Volume 4 Guide to GMP and the NOVARTIS Product Quality Review template.
Product Quality Review. 5.1 Shasun shall perform an annual product review as required by ICH Q7A section 2 part E Product Quality Review. A copy of the summary of the product quality review shall be provided to Reliant QA.
Product Quality Review. DISTRIBUTOR shall be responsible for the performance of the single reviews, compilation, assessment and filing of the Product Quality Reviews to the Regulatory Authorities, if applicable. To the extent it is required that information related to the shipment, storage and distribution of the Product by the DISTRIBUTOR has to be included in a Product Quality Review, DISTRIBUTOR shall use commercially reasonable efforts to provide such information to VIFOR according to the schedule and format to be agreed between the Parties.
Product Quality Review. Patheon shall provide data to enable Zogenix to perform trending and critical analysis for the Product during each Year of the Agreement (a “Product Quality Review”). The data relating to the Product to be provided by Patheon will be sufficient to allow Zogenix to fulfil its annual reporting obligations to the FDA and will include but not be limited to:
(i) Materials
(ii) Critical in process control and finished product testing results
(iii) Deviations and out of specifications
(iv) Changes to Materials or the Product
(v) Stability studies
(vi) Complaints relating to the Product
(vii) Corrective and preventive actions
(viii) Qualification and validation of equipment and processes used in the manufacture of the Product
(ix) Quality Agreement hereinafter collectively the “PQR Data”. The cost of providing the PQR Data shall be included in the Service Fee. In the event that Zogenix requests that Patheon provides data over and above the PQR Data or that Patheon perform trending and critical analysis on the PQR Data, then Zogenix shall reimburse Patheon for such services as set out in Schedule B;
Product Quality Review. Patheon shall perform Product Quality Reviews as set forth in the Quality Agreement for the separate fees specified in Schedule 7.1.
Product Quality Review. Patheon shall provide data to enable Zogenix to perform trending and critical analysis for the Product during each Year of the Agreement (a “Product Quality Review”). The data relating to the Product to be provided by Patheon will be sufficient to *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. allow Zogenix to fulfil its annual reporting obligations to the FDA and other Regulatory or Government Authorities and will include but not be limited to:
(i) Materials
(ii) Critical in process control and finished product testing results
(iii) Deviations and out of specifications
(iv) Changes to Materials or the Product
(v) Stability studies
(vi) Complaints relating to the Product
(vii) Corrective and preventive actions
(viii) Qualification and validation of equipment and processes used in the manufacture of the Product
(ix) Quality Agreement hereinafter collectively the “PQR Data”. The cost of providing the PQR Data shall be included in the Service Fee. In the event that Zogenix requests that Patheon provides data over and above the PQR Data or that Patheon perform trending and critical analysis on the PQR Data, then Zogenix shall reimburse Patheon for such services as set out in Schedule B;
Product Quality Review. 11.1 SUPPLIER shall conduct a periodic quality review of PRODUCT on an annual basis in accordance with defined procedures and regulatory requirements.
