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. [***] [***]
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. Reference Standards/ Materials
Laboratory Controls. 4.11.1 Specifications and Test Methods [**] [**]
Laboratory Controls. 20.1 Maintain written procedures for sample management, identification, testing, disposition and recording, approval, tracking, storage, retention and disposal of laboratory data. --- --- ×
20.2 Hold samples and dispose of as required by specifications and procedures. --- --- ×
20.3 Destroy samples and sample packaging in a secure and legal manner that prevents unauthorized use or diversion in accordance with approved procedures. Maintain destruction records. Destruction method must render any registrations, logos or trademarks unidentifiable. --- --- ×
20.4 Maintain approved written procedures for management, preparation and use of reference standards, reference materials, reagents, and solutions including qualification/requalification of use period. --- --- ×
20.5 Source, grade and characterization of reference standards/materials according to Manufacturer SOP. --- --- ×
20.6 Have appropriate specifications and test procedures for the Product, which are consistent with the applicable, approved Marketing Authorization and/or compendia monograph. --- --- ×
20.8 In case of method changes verify compendia test methods (i.e. USP, EP, BP, JP). Provide a confirmation of equivalency to DKSH and CMS, if applicable. Follow approved change to test procedures for changing test methods. --- --- ×
21.1 Perform retesting, in accordance with approved protocols or procedures (OOS SOP). --- --- ×
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. 12.01 Have written procedures for sample management, testing, approval, disposition, recording, storage, retention and disposal of laboratory data. x
12.02 Retain samples as required by regulatory agencies. x
12.03 Have written procedures and appropriately document the preparation, use and management of reagents, solutions, and standards x
12.04 Test Product in accordance with methods already established by Supplier or any other method that the Parties may agree and approve from time to time. x
12.05 Have a program for qualification, calibration, and preventive maintenance of all analytical equipment. x
12.06 Responsible for analytical method development as appropriate. x
Laboratory Controls. 13.1 Ensure that all Materials are tested and released in accordance with Supplier Specifications, Test Methods, Monographs, SOPs and CGMPs. X
13.2 Notify Purchaser’s Quality Unit of confirmed Out of Specification (OOS) results within two (2) Business Days related to the testing of the API. Purchaser will be notified prior to the release decision of any impacted lots/batches of API. Provide a copy of completed OOS test result Investigations with the Batch Documentation. X
13.3 Notify Purchaser’s Quality Unit of confirmed Out of Trend (OOT) results within two (2) Business Days. X
13.4 Use qualified/validated analytical methodology for the release and stability testing of Materials (as appropriate) and API according to Supplier Quality Systems. X
13.5 For analytical methodology supplied by Purchaser, Supplier will transfer according to Supplier’s procedures, and may evaluate the appropriateness of the methodology to ensure compliance with CGMPs and Supplier SOPs. X
13.6 Notify Supplier of any confirmed test result of API that fails to meet the Specifications for testing performed by Purchaser five (5) Business Days of Purchaser’s discovery of the failure. X
13.7 Perform at least one identification test on Materials (provided the Materials are not of a hazardous nature, or provided sampling is not expected to be detrimental to the integrity of the material, in which case they may be accepted on a Certificate of Analysis basis). X
13.8 Maintain SOPs for instrument qualification, operation and maintenance in accordance with CGMPs. X
13.9 According to preapproved criteria, manage, store, and certify/recertify the primary reference standards for DCA and DCA Intermediates. Contact Purchaser at least one (1) month prior to a reference standard requiring recertification.
