Quality Unit Responsibilities Sample Clauses
Quality Unit Responsibilities. 4.2.1. The quality unit shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The responsibilities and procedures applicable to the quality unit shall be in writing; and the written procedures shall be followed.
4.2.2. The quality unit shall be responsible to assure adequate testing facilities are available and utilized for the testing of raw materials, components, API containers, closures, packaging materials, in-process materials, and drug products.
4.2.3. The quality unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.
Quality Unit Responsibilities. 2.1 Maintain a Quality Unit that is independent of the production unit and has the responsibility and authority to approve or reject Materials, API, Standard Operating Procedures, Master Batch Records, Deviations, Investigations, change controls, stability protocols/reports and Production Batch Records. X
2.2 Ensure the requirements of the Quality Agreement have been, or will be, incorporated into Supplier’s systems/programs/documentation. Kythera Quality contact will provide clarification as needed, and assess adherence, or timelines for adherence, to the Quality Agreement. X X 2.3 Contact persons for the Supplier and Purchaser are listed in Exhibit D. X X
Quality Unit Responsibilities. The Quality Unit of each party is responsible for the process or service it performs. The assignment of particular responsibilities to either party does not relieve any party from compliance with cGMP requirements that are not specifically set forth in this agreement. The CUSTOMER is ultimately responsible for approving or rejecting product(s) mentioned in section 1.3 of this agreement, manufactured, processed, packed, or held under contract by POCONO. Although the Quality Unit of POCONO is responsible for release of the device from the operations it performs, final device release of finished goods for distribution must be carried out by the CUSTOMER and the responsibility cannot be delegated to another party under the cGMP regulations or any terms of the Quality Agreement. All parties will comply with cGMP’s and applicable local (state and national) authorities as agreed by the parties. ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ phone: (▇▇▇) ▇▇▇-▇▇▇▇ email: ▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇.▇▇▇ ▇▇▇▇ ▇▇▇▇ phone: (▇▇▇) ▇▇▇-▇▇▇▇ email: ▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇.▇▇▇ ▇▇▇▇ ▇▇▇▇ phone: (▇▇▇) ▇▇▇-▇▇▇▇ email: ▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇.▇▇▇