Validation/Qualification. 10.1 Maintain a written master validation/qualification plan for the facilities, equipment/instruments, manufacturing process, cleaning procedures, analytical procedures, in process control tests and computerized systems approved by the quality unit. --- --- ×
10.2 Prepare and maintain validation/qualification documentation approved by the quality unit, including protocols, reports and associated documentation. Provide such documents during audits. --- --- ×
10.3 Sections 10.3 through 10.10 are only applicable to new or replaced equipment. Validate/qualify as necessary all critical systems, utilities and equipment/instruments used for the manufacture and control of Product (Installation Qualification (IQ), Operational Qualification (OQ), and/or Performance Qualification (PQ)). --- --- ×
10.4 Computer systems and associated software used in Good Manufacturing Practices related activities associated with the Product should be validated/qualified. Procedures must be in place to assure the integrity, archiving, retrieval and destruction of the electronic data that comply with applicable regulations. --- --- ×
10.5 Validate/qualify methods and procedures for cleaning of equipment with acceptance criteria for residues defined and justified. --- --- ×
10.6 Develop and execute a plan for process and method validation/qualification. --- --- ×
10.7 Where method validation is performed by Manufacturer: • Manufacturer shall write method validation protocol, • Manufacturer shall review and approve method validation protocol • Manufacturer shall execute method validation protocol, • Manufacturer shall write method validation report, and • Manufacturer shall review and approve method validation report. --- --- × --- --- × --- --- × --- --- × --- --- ×
10.8 For process validation: • Write process validation protocol, • Review and approve process validation protocol. • Execute process validation protocol, • Write process validation report, and • Review and approve process validation report. --- --- × --- --- × --- --- × --- --- × --- --- ×
10.9 Validate/qualify all manufacturing processes, Product formulation, mixing operations and hold times for the formulation process according to Nordmark SOP. --- --- ×
10.10 Evaluate protocol deviations encountered during validation/qualification to determine impact on validation/qualification studies, including need to conduct repeat studies. --- --- ×
10.11 Evaluate validated/qualified systems and processes periodically to verify the...
Validation/Qualification. 15.01 Determine according to Product lifecycle and guidance documents when process validation is required. X
15.02 Have a written master validation/qualification plan for the facilities, equipment/instruments, manufacturing process, cleaning procedures, analytical procedures, in process control tests and computerized systems as appropriate. These to be approved by the quality unit. X
15.03 Responsible for developing, preparing and maintaining validation documentation approved by the quality unit, including protocols, reports and associated documentation. X
15.04 Qualify as necessary all critical systems and equipment used for the manufacture and control of Product (Installation Qualification (IQ), Operational Qualification (OQ), and/or Performance Qualification (PQ)). X
Validation/Qualification. 10.01 Have a written master validation/qualification plan for the facilities, equipment/instruments, manufacturing process, cleaning procedures, analytical procedures, in process control tests and computerized systems approved by the quality unit. X
10.02 Prepare and maintain validation/qualification documentation approved by the quality unit, including protocols, reports and associated documentation. Provide such documents to Wyeth upon request. X
10.03 Validate/qualify as necessary all critical systems, utilities and equipment/instruments used for the manufacture and control of Product (Installation Qualification (IQ), Operational Qualification (OQ), and/or Performance Qualification (PQ)). X
10.04 Validate/qualify computer systems and associated software used in Good Manufacturing Practices related activities associated with the Product. Procedures must be in place to assure the integrity, archival, retrieval and destruction of the electronic data that comply with applicable regulations. X
Validation/Qualification. 7.01 Determine according to Product lifecycle and guidance documents when process validation is required. 🞏 🞏 🗹
7.02 Have a written master validation/qualification plan for the facilities, equipment/instruments, manufacturing process, cleaning procedures, analytical procedures, in process control tests and computerized systems as appropriate. These to be approved by the quality unit. Client may provide validated methods, process validation, and in-process controls. Written copies to be provided to Supplier. 🞏 🗹 🗹
7.03 Responsible for developing, preparing and maintaining validation documentation approved by the quality unit, including protocols, reports and associated documentation. 🞏 🞏 🗹
7.04 Qualify as necessary all critical systems and equipment used for the manufacture and control of Product (Installation Qualification (IQ), Operational Qualification (OQ), and/or Performance Qualification (PQ)). 🞏 🞏 🗹
7.05 Allow viewing of the validation documentation for the Product during an onsite audit. 🞏 🞏 🗹
Validation/Qualification. 10.01 Maintain a written master validation/qualification plan for the facilities, equipment/instruments, manufacturing process, cleaning procedures, analytical procedures, in process control tests and X computerized systems approved by the quality unit.
10.02 Prepare and maintain validation/qualification documentation approved by the quality unit, including protocols, reports and associated documentation. Provide such documents to Manufacturer upon request. X
10.03 Validate/qualify as necessary all critical systems, utilities and equipment/instruments used for the manufacture and control of Product (Installation Qualification (IQ), Operational Qualification (OQ), and/or Performance Qualification (PQ)). X
10.04 Computer systems and associated software used in Good Manufacturing Practices related activities associated with the Product should be validated/qualified. Procedures must be in place to assure the integrity, archiving, retrieval and destruction of the electronic data that comply with applicable regulations. X
10.05 Validate/qualify methods and procedures for cleaning of equipment with acceptance criteria for residues defined and justified. X
10.06 Develop and execute a plan for process and method validation/qualification including definition of roles and responsibilities between Customer and Manufacturer for performing technology transfers, if applicable. X X
10.07 Where method validation is performed by Manufacturer: • Manufacturer shall write method validation protocol, X • Customer and Manufacturer shall review and approve method validation protocol. Customer should make a good faith effort to provide feedback within 5 business days or notify Manufacturer. X X • Manufacturer shall execute method validation protocol, X • Manufacturer shall write method validation report, and X • Customer and Manufacturer shall review and approve method validation report. Customer should make a good faith effort to provide feedback within 5 business days or notify Manufacturer. X X
10.08 For process validation: • Write process validation protocol, X • Review and approve process validation protocol. Make a good faith effort to provide feedback within 5 business days or notify The author. X X • Execute process validation protocol, X • Write process validation report, and X • Review and approve process validation report. Make a good faith effort to provide feedback within 5 business days or notify the author. X X
10.09 Validate/qualify all manufacturing processes, Pro...
Validation/Qualification. Theravance and ScinoPharm agree to the following Validation/Qualification Policy for the Product:
1. Equipment and facilities/utilities qualification/validation shall be performed for process, packaging, analytical methods, cleaning, and computerized systems.
2. Validation shall consist of prospective performance on at least three consecutive production batches. Validation must be conducted with commercial production/analytical processes and equipment.
3. Revalidation shall be performed for significant changes to existing manufacturing process, packaging, analytical, etc. (as determined by Theravance QA). The number of batches required for revalidation will be determined by Theravance and ScinoPharm based on the significance of the change.
4. Theravance colleagues shall have the right to be present during the manufacture of validation and launch batches.
5. Cleaning Validation shall involve three replicate runs of cleaning procedure for contact equipment during Process and Packaging Validation, except for dedicated equipment which will require one verification run of the cleaning procedure.
6. Theravance shall have the right to require full or partial revalidation for changes made to the validated product, based on a shared change control system and an assessment of the significance of the change. ScinoPharm will notify Theravance QA of any planned changes to a validated process or associated procedures sufficiently in advance to allow Theravance an opportunity to assess the change(s) and any ramifications. No changes shall be made to the validated process or product without prior written consent of Theravance QA. Copies of associated documents are to be provided to Theravance QA. Theravance QA will forward these documents to the applicable markets.
Validation/Qualification. Determine according to Product lifecycle and guidance documents when process validation is required.
Validation/Qualification. 7.01 Determine according to Product lifecycle and guidance documents when process validation is required. [*] [*] [*]
7.02 Have a written master validation/qualification plan for the facilities, equipment/instruments, manufacturing process, cleaning procedures, analytical procedures, in process control tests and computerized systems as appropriate. These are to be approved by the quality unit. [*] [*] [*]
7.03 Responsible for developing, preparing and maintaining validation documentation approved by the quality unit, including protocols, reports and associated documentation. [*] [*] [*]
7.04 Qualify as necessary all critical systems and equipment used for the manufacture and control of Product (Installation Qualification (IQ), Operational Qualification (OQ), and/or Performance Qualification (PQ)). [*] [*] [*]
7.05 Allow viewing of the validation documentation for the Product during an onsite audit. [*] [*] [*]
Validation/Qualification. 7.01 Determine according to Product lifecycle and guidance documents when process validation is required. ✔
7.02 Have a written master validation/qualification plan for the facilities, equipment/instruments, manufacturing process, cleaning procedures, analytical procedures, in process control tests and computerized systems as appropriate. These to be approved by the quality unit. ✔
7.03 Responsible for developing, preparing and maintaining validation documentation approved by the quality unit, including protocols, reports and associated documentation. ✔
7.04 Qualify as necessary all critical systems and equipment used for the manufacture and control of Product (Installation Qualification (IQ), Operational Qualification (OQ), and/or Performance Qualification (PQ)). ✔
7.05 Allow viewing of the validation documentation for the Product during an onsite audit. ✔
Validation/Qualification. Both parties agree to the following Validation/Qualification Policy. UCB representatives shall have the right to attend the manufacture of validation and launch batches. Equipment and facilities/utilities qualification/validation shall be performed for process, packaging, analytical methods, cleaning, and computerised systems. Process Validation shall consist of prospective performance on at least three consecutive production batches and must be conducted with commercial production/analytical processes and equipment. Manufacturer will not use any validation protocol or issue a report unless UCB have first approved such validation protocol or report. UCB will approve or reject all protocols and validation reports within fifteen (15) Business Days of receipt. Cleaning Validation shall involve three replicate runs of cleaning procedure for PRODUCT contact equipment during Process and Packaging Validation, except for dedicated equipment which will require one verification run of the cleaning procedure. The cleaning procedure and analytical methodology will be reviewed by both parties before the first Product Batches are manufactured. Revalidation shall be performed for significant changes to existing manufacturing processes, packaging, analysis, etc. (as determined by UCB). UCB shall have the right to required full or partial revalidation for changes made to the validated PRODUCT, based on a shared change control system and an assessment of the significance of the change. CONTRACT ACCEPTOR will notify UCB of any planned changes to a validated process or associated procedures sufficiently in advance to allow UCB an opportunity to assess the change(s) and any ramifications. No changes shall be made to the validated process or PRODUCT without prior written consent of UCB. The number of batches required for revalidation will be determined by UCB and CONTRACT ACCEPTOR based on the significance of the change.
