ANSI/PDA Standard 001-2020

Enhanced Purchasing Controls to Support the Bio-Pharmaceutical, Pharmaceutical, Medical Devices and Combination Products Industries

The purpose of this document is to ensure that there is an awareness of the requirements for purchasing controls for a specific material, component, product, or service throughout the product lifecycle and that the responsibility for compliance at all stages is shared throughout the entire organization, with final responsibility falling to the management of the company. Current quality management systems can be made more effective in preventing counterfeit, substandard, or adulterated materials from entering the market and potentially harming patients. The above citations are the minimum requirements that can be exceeded as part of each manufacturer’s internal policies and procedures. Implementation of risk-based processes will better define purchasing controls responsibilities, authorities, and accountabilities. Even though several different organizations have various roles in purchasing controls, including supplier recommendations and selection, an independent Quality Unit must approve all suppliers for purchases that are related to or have an impact on GMP requirements. The procedures shall describe the operating instructions and best practices for manufacturers of FDA-regulated products. It is intended to expand on the requirements already defined under FDA regulations for pharmaceutical products, medical devices, and combination products and ICH guidance. This standard represents current thinking on the topic and should be viewed only as recommendations, unless activities in the standard are specified by a regulatory or statutory requirement. An alternative approach might be appropriate if the approach satisfies the requirements. Therefore, in the USA FDA Medical Device Quality Systems CGMPs, there is an entire section on Management Responsibility (2).