Laboratory Controls. U. Retest
Laboratory Controls. 9.01 Have written procedures for sample management, testing, approval, disposition, recording, storage, retention and disposal of laboratory data. X
9.02 Retain samples as required by regulatory agencies. X
9.03 Have written procedures and appropriately document the preparation, use and management of reagents, solutions, and X standards.
9.04 Have appropriate specifications and test procedures for the Product which are consistent with the applicable approved filing and/or compendia) monograph. X X
9.05 Test Product in accordance with approved validated or qualified methods and specifications using calibrated equipment. X
9.06 Have a program for qualification, calibration, and preventive maintenance of all analytical equipment. X
9.07 Responsible for analytical method development, qualification and or validation as appropriate. X X 9.08 Responsible for transferring any developed methods to Supplier. X
Laboratory Controls. Have written procedures for sample management, identification, testing, disposition and recording, approval, tracking, storage, retention and disposal of laboratory data. X
Laboratory Controls. Reference Standards/ Materials
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. 4.11.1 Specifications and Test Methods [**] [**]
Laboratory Controls. 15.01 Have written procedures for sampling, sample management, testing, approval, disposition, recording, storage, retention and disposal of laboratory data.
15.02 Retain samples as required by regulatory agencies. Supplier will store Product retention samples, sufficient to perform at least two (2) full specification analyses, in containers that are equivalent to or more protective than the commercial packaging. Samples are to be retained for at least one (1) year after the expiry or retest date of the batch assigned by Supplier or for three (3) years after distribution, whichever is the longer.
15.03 Have written procedures and appropriately document the preparation, use and management of reagents, solutions, and standards.
15.04 Use adequately qualified or certified reference standards. All reference standards should be stored in accordance with the suppliers recommended storage conditions and used within their given expiry or retest date.
15.05 Have appropriate specifications and test procedures for the Product which are consistent with the applicable approved filing and/or compendial monograph.
15.06 Test Product in accordance with approved validated or qualified methods and specifications using calibrated equipment.
15.07 Have a program for qualification, calibration, and preventive maintenance of all analytical equipment.
15.08 Responsible for analytical method development, qualification and or validation as appropriate. Likewise Compendial analytical methods must be verified prior to their use for release of commercial Product lots.
15.09 Responsible for transferring any developed methods to Supplier.
15.10 Provide to Client any in-house methods, including validation reports, used for testing according to the agreed specifications (where there are no compendial methods) under an executed and in-force non-disclosure agreement.
15.11 If commercially available reference standards are not available, reference standards for the Product will be made available under agreed-upon terms.
Laboratory Controls. 11.1 Has a written procedure for sample management, testing, approval, disposition, recording, storage, retention and disposal of laboratory data. x
11.2 Retains samples of the Cannabis Starting Materials as required by regulatory agencies. x x
11.3 Has written procedures and appropriately document the preparation, use and management of reagents, solutions, and standards for testing the Cannabis Starting Materials. x
11.4 Defines release specifications for Medicinal Cannabis Starting Materials. x
11.5 Responsible for having appropriate test procedures for Medical Cannabis Starting Materials. x
11.6 Responsible for testing the contracted materials in accordance with approved validated or qualified methods and specifications using calibrated equipment. x
11.7 Responsible for the third party laboratory testing Medical Cannabis Starting Materials in accordance with approved validated or qualified methods and specifications using calibrated equipment. x
11.8 Responsible for having a program for qualification, calibration, and preventive maintenance of all analytical equipment. x
11.9 Responsible for the third party laboratory having a program for qualification, calibration, and preventive maintenance of all analytical equipment. x
11.10 Responsible for analytical method development, qualification and/or validation as appropriate. x
Laboratory Controls. Lonza Responsibility Customer Responsibility and Rights
Laboratory Controls. 4.12.1 Specifications and Test Methods X X 4.12.2 Out of Specifications (OOS) / Out of Trend (OOT) X 4.13.1 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 4.14.1 General X X 4.15.1 General X 4.15.2 Product Storage and Shipment Changes (X) X 4.15.3 Product Quarantine X 4.16.1 Complaint Investigation X (X) 4.17.1 Product Recall Notification X 4.17.2 Government Agency Notification X