Supplier Quality Standard 1.0 Purpose - …

1 Baxter International Inc. One Baxter Parkway Deerfield, IL 60015. (224) 948-2000. Supplier Quality Standard Purpose The Purpose of this Supplier Quality Standard is to communicate the expectations and requirements of Baxter Healthcare Corporation to its suppliers. These expectations are based on Baxter's philosophy of defect prevention and continuous improvement by developing Quality into products and services rather than defect detection after they are produced. The requirements within this Standard are provided as a supplement to, and do not replace or alter the terms or conditions within Baxter's Purchase Orders, Quality Agreements, engineering drawings and/or specifications and/or any agreement between Baxter and the Supplier . In this Standard , sentences containing shall are requirements, sentences in italics or containing should are provided for guidance only. Applicability This Standard , identified in the Quality Agreement, applies to Baxter suppliers who provide: Parts Materials Assemblies Printed Material Services, which can impact product Quality Finished goods, both those that carry the Baxter trademark, as well as distributed product.

2 Contract Design and Development Custom application or embedded software Associated Documents Reference ISO 9001 Quality Management Systems Requirements ISO/TR 10017 Guidance on Statistical Techniques for ISO 9001. ISO 13485 Medical Devices Quality Management Systems Requirements for Regulatory Purposes 2nd Edition ISO14001 Environmental Management Standard This document is for informational purposes only. Should you need further information, please contact your Purchasing representative. ISSUE DATE: 09-JUL-2014. EFFECTIVE DATE: 07-SEP-2014. Baxter International Inc. One Baxter Parkway Deerfield, IL 60015. (224) 948-2000. ISO14971 Medical Devices Application of risk management to medical devices ICH Q7A good manufacturing Practice Guide for Active Pharmaceutical Ingredients ICH8 Pharmaceutical Development ICH9 Quality Risk Management ICH10 Pharmaceutical Quality Systems Handbook EudraLex Volume 1 Pharmaceutical Legislation Medicinal Products for Human Use EudraLex Volume 2 Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use EudraLex Volume 4 good manufacturing Practice (GMP) Guidelines EUCD 93/42 European Union Commission Directive Medical Device Directive (MDD).

3 FDA 21 CFR 820 Title 21 Food and Drugs, Subchapter H Medical Devices, Parts 820 Quality System Regulation FDA 21 CFR 210 & 211 Title 21 Food and Drugs, Subchapter H Medical Devices, Parts 210 & 211 cGMP in manufacturing , Processing, Packaging, or Holding of Drugs and Finished Pharmaceuticals FDA 21 CFR 606 Title 21 Food and Drugs, cGMP for Blood and Blood Components FDA 21 CFR 610 Title 21 Food and Drugs, General Biological Product Standards Health Canada Canadian Medical Device Regulations Health Canada Canada good manufacturing Practices (GMP) Guidelines IPEC PQC GMP The Joint IPEC-PQC good manufacturing Practices Guide for Pharmaceutical Excipients MHLW Japanese Pharmaceutical Affairs Law MHLW No. 179 Japan - Ministerial Ordinance on Standards for manufacturing Control and Quality Control for Drugs and Quasi-drugs MHLW No. 169 Japan Ministerial Ordinance on Standards for manufacturing Control and Quality Control for Medical Devices and In-vitro Diagnostic Reagents This document is for informational purposes only.

4 Should you need further information, please contact your Purchasing representative. ISSUE DATE: 09-JUL-2014. EFFECTIVE DATE: 07-SEP-2014. Baxter International Inc. One Baxter Parkway Deerfield, IL 60015. (224) 948-2000. Definitions Definitions are available in Appendix I (Section 13) of this Standard . Responsibility and Authority It is the responsibility of the Supplier to understand and ensure compliance with this Standard and Baxter's engineering requirements, specifications and drawings. Supplier Quality personnel within Baxter are responsible for maintaining this Standard and establishing, maintaining and evaluating approved suppliers. Introduction This Standard emphasizes: The importance of establishing defined and mutually agreed upon requirements. The expectation that suppliers develop and maintain a comprehensive Quality system that ensures Baxter receives product and services that conform to requirements.

5 A continual focus on improvement in Quality , cost, and innovation, including sustainability, to mutually benefit the Supplier and Baxter. manufacturing in accordance with appropriate current good manufacturing Practices (cGMP). Supplier Expectations Baxter's suppliers shall develop and maintain a management system to assure consistent conformance of their products and services to specified requirements. Note: A Quality system that demonstrates conformity to ISO 9001 establishes a base from which a Supplier can focus on Quality and continually strive to improve. Although not required by Baxter, suppliers are encouraged to have their conformance confirmed by an independent audit (such as 3rd party certification). Suppliers shall fully comply with the Baxter Ethics and Compliance Standards for Suppliers/ Code of Conduct discussed later in this manual. Suppliers are fully responsible for the Quality of their products.

6 Suppliers shall ensure that each of their products or services comply with all the requirements mutually agreed to with Baxter as well as all applicable requirements defined by regulatory agencies (such as FDA and Health Canada). Suppliers are accountable for and assume full responsibility for the Quality of the products or services they provide. Approval and verification, by Baxter, of Supplier 's facilities, systems, and records does not absolve the Supplier of the responsibility to provide acceptable product. This document is for informational purposes only. Should you need further information, please contact your Purchasing representative. ISSUE DATE: 09-JUL-2014. EFFECTIVE DATE: 07-SEP-2014. Baxter International Inc. One Baxter Parkway Deerfield, IL 60015. (224) 948-2000. Suppliers are fully responsible for their supply chain. Baxter's suppliers are responsible for the Quality and material compliance related activities of their suppliers, subcontractors, service providers, and/or material sources.

7 Suppliers shall document and verify that their suppliers' facilities, procedures, materials, and controls meet or exceed the agreed to requirements. Baxter should request supporting data of these evaluations. Baxter shall rely on its Supplier 's to maintain control of their supply base, but reserves the right to audit or evaluate these sources to ensure supply chain safety and/or understand other potential impacts to Baxter. Quality System Requirements Baxter's suppliers shall have a defined Quality system. This section specifies the requirements of a comprehensive Quality system that is important to ensure Baxter receives products and services that conform to requirements. Quality Manual, Policy and Objectives The Supplier shall document its Quality system. This should include a stated Quality policy and Quality manual. Note: A Quality manual defines the structure of their Quality system, by defining the scope of the Quality system, by describing how processes of the Quality system interact and by referencing documented procedures used to implement the Quality system.

8 The Quality policy defines a Supplier 's intent and direction with respect to Quality and serves as a general framework for action. Measurable Quality objectives shall be established. The Supplier 's Quality objectives shall be measurable and consistent with the Quality policy. Once Quality objectives are established for relevant functions and levels of the Supplier 's organization they shall be monitored by the Supplier to ensure an effective Quality system and customer focus. The Supplier shall identify its necessary procedures and records that ensure effective operation and control of its processes. Control of Documents The Supplier shall identify essential documents relating or pertinent to the Quality system and control such documents. The Supplier 's document control methods shall ensure that only approved, issued, and effective documents are utilized. Documents shall be legible and identifiable.

9 With respect to documents which become obsolete but are retained, the Supplier shall have a method of identification of such documents as obsolete and segregation of such documents to prevent accidental use. This document is for informational purposes only. Should you need further information, please contact your Purchasing representative. ISSUE DATE: 09-JUL-2014. EFFECTIVE DATE: 07-SEP-2014. Baxter International Inc. One Baxter Parkway Deerfield, IL 60015. (224) 948-2000. Control of Records The Supplier shall maintain legible, readily identifiable and retrievable records as evidence its products meet Baxter's requirements. Examples of records a Supplier should retain, to demonstrate its conformance to requirements, include test results, equipment verification records and calibration records. The Supplier shall define how it identifies, stores, protects, retains and disposes of its records.

10 Note: A Supplier should determine its record retention period to be equivalent to the lifetime of the product, as defined by the Supplier unless Baxter defines the record retention duration per the Quality Agreement. Note: The Supplier should use good Documentation Practices (GDP) when creating and maintaining records to ensure clear, complete and accurate information is recorded. Baxter recommends that the Supplier have rules that describe GDP when approving, making handwritten entries on, copying, and/or modifying documents. Some GDP examples are avoiding the use of white out to make corrections, avoiding the use of pencil, ensuring records are dated correctly at the time created, recording the appropriate approvals, and ensuring personnel don't review and approve their own work. Management Responsibility The Supplier shall ensure that responsibilities and authorities are defined, documented, and communicated within its organization.