Laboratory Controls Clause Samples

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. 15.01 Have written procedures for sample management, testing, approval, disposition, recording, storage, retention and disposal of laboratory data.    15.02 Retain samples as required by regulatory agencies.   

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. 15.01 Have written procedures for sample management, testing, approval, disposition, recording, storage, retention and disposal of laboratory data. [*] [*] [*] 15.02 Retain samples as required by regulatory agencies. [*] [*] [*] 15.03 Have written procedures and appropriately document the preparation, use and management of reagents, solutions, and standards. [*] [*] [*] 15.04 Have appropriate specifications and test procedures for the Product which are consistent with the applicable approved filing and/or compendial monograph. [*] [*] [*] 15.05 Test Product in accordance with approved validated or qualified methods and specifications using calibrated equipment. [*] [*] [*] 15.06 Have a program for qualification, calibration, and preventive maintenance of all analytical equipment. [*] [*] [*] 15.07 Responsible for analytical method development, qualification and/or validation as appropriate. [*] [*] [*] 15.08 Responsible for transferring any developed methods to UPM. [*] [*] [*] 15.09 If commercially available reference standards are not available, reference standards for the Product will be provided. [*] [*] [*]

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. 15.01 Have written procedures for sample management, testing, approval, disposition, recording, storage, retention and disposal of laboratory data. ✔ 15.02 Retain samples as required by regulatory agencies. ✔ 15.03 Have written procedures and appropriately document the preparation, use and management of reagents, solutions, and standards. ✔ 15.04 Have appropriate specifications and test procedures for the Product which are consistent with the applicable approved filing and/or compendial monograph. ✔ ✔ 15.05 Test Product in accordance with approved validated or qualified methods and specifications using calibrated equipment. ✔ 15.06 Have a program for qualification, calibration, and preventive maintenance of all analytical equipment. ✔ 15.07 Responsible for analytical method development, qualification and or validation as appropriate. ✔ 15.08 Responsible for transferring any developed methods to Supplier. ✔ 15.09 If commercially available reference standards are not available, reference standards for the Product will be provided. ✔ ✔

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.