Achieve Greater Efficiencies in the Supply Chain: An Overview of Key Supplier Quality Questionnaires
Creating efficiencies in the supply chain, especially when it comes to auditing suppliers and manufacturers, is mission critical. With so many moving pieces, it can be difficult to ensure supply chain integrity. That’s where a trusted partner like Rx-360 comes into play.
At Rx-360, our mission is to protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and quality of its materials. One of the ways we share information is through questionnaires created by members of Working Groups.
These four questionnaires, created by members of Rx-360’s Supplier-Led Working Group, help life sciences leaders ensure supply chain integrity.
The Supplier-Led Working Group is an Rx-360 working group consisting of members from both pharmaceutical companies and leading suppliers to the pharmaceutical industry. Through this Working Group, both pharmaceutical and supplier members share perspectives and work collaboratively to achieve greater efficiencies in the supply chain and to better serve patients in the long-term.
This article provides a brief overview of the four questionnaires:
Questionnaire 1: Human Blood Origin Requirements
The new realm of cell and gene therapy drugs has created new challenges in the way raw materials are used in the manufacturing process. Where there could be multiple viral inactivation/viral clearance steps in the manufacturing process for small molecules and biologics, this is not possible for cell and gene therapies as the cells cannot withstand the extremes of pH and heat required to ensure viral inactivation/clearance. Manufacturers have to mitigate the risk upstream before the raw materials are introduced into the manufacturing process. A risk-based approach is recommended to characterize raw materials and implement risk appropriate mitigation steps.
The use of raw materials of human or animal-origin is not encouraged by regulators for the manufacturing of cell and gene therapies. This is due to the inherent risk of transmitting adventitious agents such as viruses, mycoplasma, bacteria and Transmissible Spongiform Encephalopathy (TSE) agents, the potential for adverse immune reaction, and the potential variability in composition and quality due to their biological origin. Raw materials of human origin are considered high-risk to patient safety and therefore multiple orthogonal risk mitigation measures must be incorporated before use in cell therapy processes.
Materials derived from human blood such as human serum albumin and transferrin are frequently used either as components of cell culture medium or in other processes. Suppliers of such reagents have incorporated multiple mitigation steps such as sourcing pharmaceutical grade or licensed drug product, sourcing from safe geographical regions, testing for contaminants and inactivation. In addition, this information needs to be available for review during inspections and in regulatory filings.
This questionnaire is a comprehensive list of those requirements and will be a useful document for reference. The questionnaire can be used as a tool for human blood origin material selection and qualification when incorporated in the production of advanced therapy products (cell/gene). The document is an addition to the supplier and material qualification package by Rx-360 and does not replace it.
Questionnaire 2: The Supplier Assessment Questionnaire
The Rx-360 Supplier Assessment Questionnaire (SAQ) was developed by the Rx-360 Supplier-Led Working Group. As a supply chain assessment questionnaire, it addresses the following:
- Government regulatory and customer expectations that certain levels of information be available to determine the risk(s) of the supply chain and raw materials, components and services used in the pharmaceutical industry.
- The inefficiency and waste of resources that exists by having every pharmaceutical manufacturer and supplier in the industry having to create, maintain and administer their own supply chain assessment questionnaires.
- The valuable resources continuously exhausted by suppliers of raw material, component and service suppliers in continuously completing slightly different forms of the same questionnaires, for multiple companies.
The Rx-360 SAQ covers standard topics that would be included in most supply chain assessment questionnaires. These questionnaires are more detailed than most, which ensures a reduction in the number of questionnaires requiring completion by the supplier. This significantly reduces turn-around time, creating a more efficient process, and improving the customer experience.
The Rx-360 SAQ consists of six (6) supply chain assessment questionnaire modules.
Overview of the Six Modules in the Rx-360 Supplier Assessment Questionnaire
- Module 1 is your Company Overview for high-level information regarding company and operating structures.
- Module 2 is your Site Specific Information, which provides a detailed assessment as to a specific site providing the product or services.
- Module 3 is your Product Information. This provides general information on a specific product or product family, as well as additional sub-modules which can be completed, as applicable, to determine the overall risk of the product(s) and its supply chain.
- Module 4 is your Services Supplier, which provides general information on the services performed by the company and site.
- Module 5 is your Pre-Audit Questionnaire. This summarizes information in Modules 1, 2, and 3 and is intended to prepare for onsite and remote audits for chemical and pharmaceutical products.
- Module 6 is your Single Use Bioprocessing Product Questionnaire, which is for product-specific or product-family-specific questionnaire to assist customers with the qualification of single-use products for bioprocessing.
As a member-lead organization, Rx-360 provides guidance for how to use their supply chain assessment questionnaire. Suggestions when using the SAQ include:
- Update internal procedures to include the Rx-360 SAQ Modules in lieu of customized questionnaires.
- If further detail is required for full assessment of the supply chain risk, as well as additional information for products and services, supplemental documents may be created to complement the Rx-360 SAQ.
- For suppliers, establish a regular update schedule for individual Modules to ensure the information is as current and accurate as possible.
- Ensure Supplier company logo is inserted into header field for completed questionnaire.
- The Rx-360 SAQ is intended to address the industry’s most common questions; additional information may be available from the supplier upon request.
Incorporating this pharmaceutical supplier questionnaire into your audit process can enhance efficiency, reduce resource waste, and streamline compliance efforts, ultimately improving the overall safety of patients. Download the pharmaceutical supplier questionnaire today to simplify your supply chain assessment process and ensure regulatory compliance.
Download Two Additional Vendor Questionnaires
Rx-360’s Supplier-Led Working Group has created and published two additional questionnaire documents. Eliminate time-consuming redundancies and bring efficiency to the assessment work being done by your organization.
The Vendor Questionnaire for Software has seven sections, with multiple questions each. The sections cover computer hardware, opening system, interface, software, software, electronic records, audit trails, and electronic signatures. Use this supply chain assessment questionnaire to increase efficiency when assessing your vendors’ software.
The Vendor Questionnaire for Quality Systems has 15 sections, with multiple questions each. The sections cover topics including General Company Information, System Information, Quality Management System (QMS), CAPA, Complaints, Issues, Discrepancies, Document Control / Change Control (Management), Training, Security/Information Protection, Software/Firmware Development Methodology, Product/Hardware Development Methodology, Business Continuity/Disaster Recovery, Customer Support/Service, Customer Support/Service Calibration, Third Party Contracts/Support, Quality Metrics, 21 CFR Part 11 and EU GMP Annex 11, and CFR SaaS, IaaS, and PaaS. Use this supply chain assessment questionnaire to increase efficiency when assessing your vendors’ quality systems.
Why Work with Rx-360?
Choosing Rx-360 stands as a testament to prioritizing patient safety and supply chain integrity. Unlike many audit partners you might come across, we operate on a nonprofit basis, ensuring that your best interests are always at the forefront. While third-party options might seem cost-effective, they often lack the transparency that we guarantee. Moreover, by sponsoring an audit with us, you have the potential to earn back through licensing credits. At the heart of it all, Rx-360’s unwavering commitment is to uphold the quality and safety of healthcare materials, ensuring that patients receive the best care possible. If you have any further questions, please refer to our FAQs or reach out to our dedicated team through Brian Shipley at email@example.com.