Deviations and Investigations Sample Clauses

Deviations and Investigations. In the event that a material deviation occurs during the course of the Manufacture, including Packaging, storage and analytical testing, of any batch of Product for Achieve under this Supply Agreement, Sopharma shall immediately provide Achieve with a detailed written description of any such deviation and undertake all reasonable and appropriate actions to investigate the cause of such deviation and to correct the same. A completed written report of the results of any such investigation will be provided to Achieve for such batch.

Deviations and Investigations. Any deviation during manufacture or OOS result shall be promptly investigated and documented by Nastech. A full written [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] investigation report thereof will be promptly provided to LICENSEE by Nastech and shall be subject to LICENSEE's written approval.

Deviations and Investigations. 6.2.1 Any deviation from the process and SOPs during manufacture, storage or testing must be appropriately explained, investigated, documented, and approved in the batch records or analytical records. The deviation documentation must identify the cause and the corrective action, where appropriate, and must assess product impact with respect to product quality. 6.2.2 SYNCO will communicate to CHIRON any batch or batch related component that contains a major process or testing deviation or confirmed OOS where the deviation has the likely potential to impact product quality as soon as reasonably possible.. SYNCO will also communicate as soon as reasonably possible to CHIRON any significant facility or product trend investigation that has the potential to impact product quality or product supply. 6.2.2.1 Where CHIRON performs testing, CHIRON is responsible to notify SYNCO of any batch or associated batch of product that contains a major process or testing deviation or confirmed OOS where the deviation has the likely potential to impact product safety, efficacy or quality as soon as reasonably possible. 6.2.3 Some deviations, confirmed OOS and/or failures may require that additional testing, stability, or validation be conducted. This work will be performed as agreed upon in writing by all the parties. SYNCO will not perform such additional testing on any batch of product without prior written approval from the CHIRON Quality. Testing performed according to SOPs in order to confirm an OOS does not require CHIRON prior approval. 6.2.4 Where a major investigation is open greater than 30 days from initiation, SYNCO Quality will provide to CHIRON Quality an interim report on day 31 and regularly there after until closure of the investigation. For all others, tracking and reporting will be done in accordance with site SOP's. 6.2.5 Both companies will notify one another within 24 hours of discovery if any problems are discovered that may impact product batch(s) previously released and/or shipped.

Deviations and Investigations. 6.2.1 Will investigate and document specific DEVIATIONS form the MASTER BATCH RECORDS and SPECIFICATIONS according to PPL-SD QUALITY SYSTEM X 6.2.2 Will notify Dipexium within two(2) business days upon discovery of critical DEVIATIONS/abnormalities in MANUFACTURING SUBSTANCE from STANDARD OPERATING PROCEDURES, SPECIFICATIONS, or MASTER BATCH RECORDS that may have an impact on SUBSTANCE quality. X 6.2.3 Will provide Dipexium with a copy of DEVIATION/abnormality reports on INVESTIGATIONS and resolution of such DEVIATIONS, if requested by Dipexium. Communicate with Dipexium and satisfactory resolve DEVIATION reports and/or INVESTIGATION reports that have a direct impact on the quality of SUBSTANCE. X 6.2.4 Will have the right to conduct an independent INVESTIGATION related to any DEVIATIONS/abnormalities if Dipexium deems INVESTIGATION report received from PPL-SD to be scientifically inappropriate or unreasonable. X 6.2.5 For any batch of SUBSTANCE previously delivered, will notify Dipexium promptly upon confirmation of any quality issue that may affect clinical suitability of SUBSTANCE. X

Deviations and Investigations. In the event that a material deviation occurs during the course of the Manufacture, including Packaging, storage and analytical testing, of any batch of Product(s) for Buyer under this Manufacturing Agreement, Supplier shall immediately provide Buyer with a detailed written description of any such deviation. In addition, Supplier shall undertake all reasonable and appropriate actions to investigate the cause of such deviation and to correct the same as set forth in the Quality Agreement. A completed written report of the results of any such investigation will be provided to Buyer along with the COA/COC for such batch.

Deviations and Investigations. A deviation is defined as any abnormal event that may occur during the processing of a batch, or is a departure from Specifications, approved Master Batch Record or Method of testing. Any deviation that occurs must be documented in the batch record. The significant deviations will be forwarded to UCB in conjunction with the Certificate of Conformity / Analysis). Excepted as provided in sections “Complaints” and “Stability”, CONTRACT ACCEPTOR must notify UCB within five (5) Business Days of the occurrence of a confirmed out-of specification (“OOS”) result or major process deviation (deviations potentially effecting product quality, safety, identity, purity or efficacy) relating to the PRODUCT. A confirmed OOS result is defined as a result from a raw material, in-process, or finished product testing which does not meet specifications. All Quality decisions regarding any such out-of-specification result or major process deviation involving the PRODUCT shall be made by CONTRACT ACCEPTOR in consultation with UCB. In all cases, UCB will have the final review and decision making responsibility as to the impact of the deviation(s) on the PRODUCT; this includes the disposition of the affected batch. Reworking or reprocessing protocols require UCB approval prior to execution. All investigations must be completed, documented and approved by CONTRACT ACCEPTOR prior to issuance of a Certificate of Compliance or a Certificate of Conformance. A copy of the completed investigation must be provided to UCB prior to PRODUCT release by CONTRACT ACCEPTOR. CONTRACT ACCEPTOR will notify UCB in writing of any batch of PRODUCT rejected by CONTRACT ACCEPTOR. CONTRACT ACCEPTOR will notify UCB in writing of any problems that may impact or invalidate a batch previously shipped to UCB or its Affiliates or Agents. Some deviations or investigations may require additional testing, stability or validation be conducted. This work will be performed as agreed by both parties.

Deviations and Investigations. 7.1 Millennium shall or shall request its Authorized Contractor to, subject to the terms of the relevant Third Party Agreement, investigate thoroughly any unplanned deviation from approved procedure or out of specification test result. The investigation must adhere to an approved, written procedure and be documented. Review and approval of the investigation by Millennium's Quality Unit is required prior to disposition of the Product. In the case of deviation investigation by Millennium's Authorized Contractor, Millennium QA will review and approve such investigations prior to release of the batch to Schering, in accordance with Millennium batch review and supplier qualification procedures. No Product involved in an investigation may be released to Schering until the investigation is completed. 7.2 Millennium must inform Schering within one business day of any confirmed deviation or out of specification result that could affect delivery of the Product. Millennium will inform Schering of its investigation plans if so requested by Schering. 7.3 Millennium shall track and trend corrective and preventive actions (CAPA) in response to deviations. In the case of CAPA performed by Authorized Contractors, the Authorized Contractor will track and trend CAPA. Millennium will periodically review CAPA performance of its Authorized Contractors.

Deviations and Investigations