Production Controls Clause Samples
Production Controls. 13.1. Flextronics shall have in place and maintain a quality system that meets the applicable requirements of ISO 13485:2003, FDA Quality System Regulations (21 CFR 820)for the production of the Product.
13.2. Flextronics shall have in place and maintain environmental controls meeting the applicable process control requirements of ISO 13485:2003 and FDA Quality System Regulation (21CFR820.70(c)), and applicable sections of ▇▇ ▇▇▇ ▇▇▇, and subpart C, Buildings and Facilities, for the production of the Product.
13.3. Flextronics shall inform Alimera a minimum of [****] in advance unless otherwise agreed, of any change that impacts Product specifications. This includes changes to approved suppliers for Materials that are part of any Product Specifications. Flextronics shall obtain written approval from Alimera for any changes prior to implementation of changes.
Production Controls. 6.1. SRC must have in place and maintain a Quality System that meets the appropriate requirements of ISO 9001/2, EN46001/2, and EU MDD for the production of Broncus product.
6.1.1. If the SRC Quality System is certified, SRC must provide Broncus with copy of certificates.
6.1.2. If the SRC Quality System is hot certified or registered, Broncus must evaluate the SRC Quality System per Broncus Assessment procedures.
6.2. SRC must grant access for inspection/audit of its facilities, its Quality System, and its production/inspection/test processes used for the production of Broncus product to Broncus, to Broncus’ Notified Body, and to other Regulatory Authorities/Organizations. Where appropriate and upon Broncus request, SRC must ensure that access for inspection/audit of its Sub-Contractors involved in the production of Broncus product is also granted.
6.3. Broncus may review SRC production methods and inspection/test procedures for Broncus product and specify for which, if any, Broncus approval is required.
6.4. SRC must inform Broncus in advance of any substantial changes to product specifications, product indications for use, product safety, product sterilization, materials, production processes, inspection procedures, and product labeling. SRC must obtain written approval from Broncus for such changes.
Production Controls. 13.1 It is the responsibility of GERRESHEIMER to adopt the necessary techniques and/or controls during all phases of manufacturing / packaging to control the quality of the Product. GERRESHEIMER shall maintain records of test performance sufficient to meet regulatory requirements.
13.2 As defined by the validated process, the Product will be evaluated throughout production to ensure Specifications are met.
13.3 GERRESHEIMER will reconcile all Product components and all finished Product labels in accordance with its standard operating procedures.
13.4 All Defective Product must be quarantined and the deviation investigated appropriately per GERRESHEIMER standard procedures.
Production Controls. 6.1. SRC must have in place and maintain a Quality System that meets the appropriate requirements of ISO 13485 and the EU’s MDD for the production of Asthmatx product.
6.1.1. If the SRC Quality System is certified, SRC must provide Asthmatx with copy of certificates.
6.1.2. If the SRC Quality System is not certified or registered, Asthmatx must evaluate the SRC Quality System per Asthmatx Assessment procedures.
6.2. SRC must grant access for inspection/audit of its facilities, its Quality System, and its production/inspection/test processes used for the production of Asthmatx product to Asthmatx, to Asthmatx’s Notified Body, and to other Regulatory Authorities/Organizations. Where appropriate and upon Asthmatx request, SRC must use its best efforts to secure access for inspection/audit of its Sub-Contractors involved in the production of Asthmatx product.
6.3. Asthmatx may review SRC production methods and inspection/test procedures for Asthmatx product and specify for which, if any, Asthmatx approval is required.
6.4. SRC must inform Asthmatx in advance of any substantial changes to product specifications, product indications for use, product safety, product sterilization, materials, production processes, inspection procedures, and product labeling. SRC must obtain written approval from Asthmatx for such changes.
Production Controls. 4.5.1 Test Methods and Specifications [**] [**]
Production Controls. A process control plan (or similar document) shall be established and maintained that outlines the various production operations and the process controls necessary to manufacture acceptable product for GENMARK, if not already detailed and included in the process plan. The following is a list of items that must be considered for inclusion in the process control plan, dependent upon, and where appropriate for, the complexity of the process(es) used to manufacture product for GENMARK.
1. The controls to assure only accepted process inputs are used. Inputs are the materials and parts needed to make the product.
2. Clear identification (labeling) and separation of the materials and parts stored on the production floor in order to prevent mix ups and their unintended use.
3. Controls to prevent the use of materials that have exceeded or are nearing their expiration date.
4. The process to ensure the production line has been cleared of inputs from previous production runs for a different product (i.e., a “line clearance”).
5. The assignment of a unique lot or batch number, or date code, to the production run for future reference and record keeping.
6. The manufacturing steps required (i.e., the use of a route tag).
7. The criteria for workmanship, including representative samples.
8. The process characteristics (parameters) to be controlled during production.
9. The means, such as SPC, for the continuous monitoring and control of critical-control-points in the production processes.
10. The in-process product attributes that are critical to quality are monitored during production.
Production Controls. A process control plan (or similar document) shall be established and maintained that outlines the various production operations and the process controls necessary to manufacture acceptable product for Siemens, if not already detailed and included in the process plan. The following is a list of items that must be considered for inclusion in the process control plan, dependent upon, and where appropriate for, the complexity of the process(es) used to manufacture product for Siemens.
1. The controls to assure only accepted process inputs are used. Inputs are the materials and parts needed to make the product. 2. Clear identification (labeling) and separation of the materials and parts throughout all stages of the process in order to prevent mix ups and their unintended use.
3. Controls to prevent the use of materials that have exceeded or are nearing their expiration date. 4. The process to ensure the production line has been cleared of inputs from previous production runs for a different product (i.e., a “line clearance”).
Production Controls