Laboratory Controls. 9.01 Have written procedures for sample management, testing, approval, disposition, recording, storage, retention and disposal of laboratory data. X
Laboratory Controls. U. Retest
Laboratory Controls. 4.12.1 Specifications and Test Methods [***] [***]
Laboratory Controls. 4.6.1. (15) Reference Standards 4.6.2. (9) Specifications and Test Methods 4.6.3. (14) Samples 4.6.4. (16) Stability 4.6.5. (13) Packaging, Labeling, Testing and Release of GMP API 4.7. Documentation 4.7.1. (7) Documentation 4.7.2. (20) Regulatory Submission 5. Change Control and Revisions 5.1. (5) Change Management
Laboratory Controls. 4.6.1. (15) Reference Standards/ Materials
Laboratory Controls. 13.1 Ensure that all Materials are tested and released in accordance with Supplier Specifications, Test Methods, Monographs, SOPs and CGMPs. X
Laboratory Controls. Lonza Responsibility Customer Responsibility and Rights • Perform Product release testing against Product Specification. • Right to audit. § Jointly approve Product-specific analytical Test Methods § Jointly approve Product-specific analytical Test methods • If requested by Customer, provide copies of raw data and testing records • Right to receive copies of raw data and testing records • Notify Customer of confirmed out of specification (OOS) Product release testing results where possible within one (1) business day and not to exceed three (3) business days of the out of specification being confirmed. • Review confirmed out of specification reports; comment on corrective and preventative actions. For target specifications discuss impact on quality of the Product. • Take and retain Bulk Product samples from each batch sufficient for at least two (2) full biochemical specification analyses for use in the event of an investigation on Product released for clinical trial supply. • Right to audit. • Store the above samples under appropriate conditions. • Retain samples for the period defined in the relevant standard operating procedure. • Right to audit. • Notify Customer of intent to destroy retention samples with option to send samples to Customer. • Approve destruction of samples or request receipt of samples. If reference prepared by Lonza If reference prepared by Lonza • Prepare, characterise and store Product reference standard if requested by the Customer. • Right to audit. § Jointly approve Product reference standard protocol and report § Jointly approve Product reference standard protocol and report • Provide reference standard characterisation report if required. If reference supplied by Customer If reference supplied by Customer • Store characterized Product reference standard under appropriate conditions. • Supply characterised Product reference standard with Certificate of Analysis. Confidential
Laboratory Controls. 4.12.1 Specifications and Test Methods X (API and DP) X (others)
Laboratory Controls. 15.1. Method Review CLIENT will be allowed to review all test methods prior to use by CYTOVANCE.
Laboratory Controls. 4.12.1 Specifications and Test Methods X X 4.12.2 Out of Specifications (OOS) / Out of Trend (OOT) X 4.13 Stability 4.13.1 Sample Storage X 4.13.2 Stability Studies and Protocol X X 4.13.3 Stability Failures X 4.13.4 Continue Stability on Termination of MSA X 4.14 Annual Product Review 4.14.1 General X X 4.15 Storage and Distribution 4.15.1 General X 4.15.2 Product Storage and Shipment Changes (X) X 4.15.3 Product Quarantine X 4.16 Product Complaints 4.16.1 Complaint Investigation X (X) 4.17 Product Recall 4.17.1 Product Recall Notification X 4.17.2 Government Agency Notification X
