In the pharmaceutical industry, ensuring the integrity of the supply chain, material quality, and patient safety is paramount. One of the tools that organizations use to achieve these goals is the audit process. Knowing the right steps to follow will help you streamline your supply chain audit process and improve supply chain security. How do life sciences leaders like you find information that helps create efficiencies in the supply chain?

Sharing information is part of the mission at Rx-360. For information about supply chain security, the Supplier-Led Working Group at Rx-360 has shared perspectives and worked collaboratively to create guides about GMP audits, vendor selection, the threat of illicit medicines and more.

• GMP Audits: With the increasing complexity of global supply chains, ensuring Good Manufacturing Practices (GMP) is paramount. The working group has shared best practices and methodologies to conduct thorough and effective GMP audits, ensuring that every link in the supply chain adheres to the highest standards.
• Vendor Selection: Choosing the right vendor is a critical aspect of supply chain security. The Supplier-Led Working Group has provided valuable insights into the criteria and processes that organizations should consider to select vendors that align with their supply chain security objectives.
• Threat of Illicit Medicines: The global pharmaceutical supply chain is not immune to the infiltration of counterfeit or substandard medicines. By sharing information on the latest threats, trends, and mitigation strategies, the working group plays a vital role in safeguarding the integrity of medicines and, by extension, patient safety.
• Collaborative Approach: Beyond these specific areas, the Supplier-Led Working Group emphasizes the importance of collaboration in enhancing supply chain security. By pooling resources, knowledge, and expertise, the group ensures that the broader pharmaceutical community benefits from shared experiences and lessons learned.

Managing Critical Vendors [DOWNLOAD]

A critical vendor can be defined as: A vendor that is deemed to be the major or sole provider of a critical materials and/or services, whose failure to supply goods/and or services would have the most significant impact on the organization/business.

This paper covers critical vendors that supply manufacturers (customers) of regulated products. The focus will be limited to first tier vendors. The process and best practices discussed are focused on regulatory areas of scrutiny but are able to be applied to other areas of quality concern.
The manufacture of medical products, drugs and devices is highly regulated all over the world. All aspects of the manufacturing process, from product design to product delivery, require documented procedures. Key points in the process also require quality oversight and where needed testing. Risk assessment to determine the critical areas of the process is now mandatory for regulated companies and is required for non-regulated companies that follow the ISO 9001 quality management system starting in 2015. One very important part of the whole manufacturing process is the proper sourcing and management of vendors that provide goods and services to the regulated company. This is one area in which it is very important to assess risk in order to properly manage production.

Every company should develop a program to assess and evaluate risk to determine the most critical vendors of their manufacturing process. Regulated companies have additional considerations when evaluating critical vendors. Such a program should focus on factors that can potentially disrupt the supply chain such as single source, regulatory compliance, unique capabilities of the vendor, and limited sub-tier suppliers to a key supplier. Both proactive and reactive monitoring should be utilized when managing critical vendors.

While a risk assessment or risk evaluation can be used as a tool to develop a plan to address potential issues, no plan is 100% perfect and sometimes unforeseen problems occur. When issues arise that affect a critical vendor, an action plan needs to be developed to mitigate the situation and prevent a disruption to the supply chain. This is especially true if the cause of the issue is related to regulatory compliance.

Managing Critical Vendors [DOWNLOAD]

Who Should Download Managing Critical Vendors?

Regulated industry (i.e. medical products, drugs and devices) is one that relies heavily on suppliers for the provision of materials (e.g. APIs, packaging components, excipients, etc.) and/or services (e.g. sterilization, testing, warehousing/distribution, etc.) to support their core business. Failures to meet the regulatory and compliance regulations requirements would potentially have a serious impact on the reputation and financials of an organization. The extent of the impact associated with supplier non-compliance varies and will depend on how critical the supplier is to the organization. Having a well-defined process for identifying and monitoring critical vendors is key to mitigating such risk. The following provides a summary of criteria to distinguish a critical supplier, recognizing that the distinction should be applied specifically and customers should be wary of identifying broad categories of suppliers as critical (e.g. although certain API suppliers may be critical vendors, not all API suppliers should
automatically be considered critical.

Identifying critical vendors should be an integral part of the supplier qualification process. Factors that can be used to identify critical vendors may include, but are not limited to, the following:

1. Criticality of the materials and/or services to the business. Materials and/or services associated with the production of drug product and/or medical device that are i) medically necessary (lifesaving) and ii) have limited alternatives, should be considered critical.
2. Availability of the material and/or service. Material and /or services that are provided by limited number of suppliers or by a sole supplier pose a higher risk to business.
3. Number of products/material supplied. The higher the number and/or volumes of material sourced from a supplier, the greater the risk to the supply chain.
4. Financial impact. This factor can be measured by how significant the disruption of supply of critical material and/or services by a supplier would be.

Managing Critical Vendors [DOWNLOAD]

The purpose of this document is to outline those basic GMP elements that may be required of suppliers whose products or services eventually enter the supply chain for the manufacture and delivery of regulated medical products. When established and followed, these GMP elements help to assure product quality, minimize compliance risk to the manufacturer, and protect patients. This document addresses the risks involved regarding the intended use vs. actual use of products and services.

Quality Elements of GMP Providers [DOWNLOAD]

Medical products are items used to diagnose, treat, cure, mitigate or prevent disease in patients. These include pharmaceutical products and medical devices. The manufacture of medical products that are used in the United States, and in many other countries, are regulated by Good Manufacturing Practices (GMP) and Quality System Regulations (QSR). These regulations, which are nearly identical in many countries, cover not only the manufacture of finished products, but may also encompass starting and intermediate materials and related services that are a part of the supply chain for those medical products. The result is that many medical product manufacturers require products or services from providers who adhere to GMP/QSR (collectively, “GMP”) as well.

Adoption of GMP can provide advantages to suppliers, including expanded market opportunities with the added benefit of increased profitability through improved manufacturing techniques.

Quality Elements of GMP Providers [DOWNLOAD]

Who Should Download Quality Elements of GMP Providers?

This document applies to all suppliers of products or services that have an impact on GMP processes within the supply chain for commercial manufacturing and delivery of regulated medical products.

The GMPs referred to within the document are related to regulated medical products manufacturing. When established and followed, these GMP elements help to assure product quality, minimize compliance risk to the manufacturer, and protect patients. The target audience for this report is suppliers of starting and intermediate products and related services within the supply chain used by manufacturers of medical products subject to GMP regulations. This document is written with a focus on the supplier, but explanations and expectations of the customer are also described.

Best Practices Quality Agreement Guide Version 3.0 [DOWNLOAD]

This Best Practices Quality Agreement Guide is intended to assist both Customers and Suppliers in efficiently managing the initiation, negotiation, implementation, and ongoing maintenance of quality agreements. “Supplier” is used broadly in this document to refer to a company that provides materials, products, or services. Establishing a quality agreement can be time-consuming as negotiations, misunderstandings, and inflexibility frequently cause delays in the process.

This guide contains some best practices, sample language, external references and resources, along with solutions to routine issues that come up during the quality agreement process. Perspective from both suppliers and manufacturers presents a balanced view designed to assist both parties in achieving a complete, concise agreement. Flexibility and compromise are needed in order to understand and work together to meet the requirements of both parties.

What Is The Quality Agreement Process?

The objective of the Supplier Quality Working Group is for this guide to help facilitate a more efficient and effective quality agreement negotiation process. As with all of our other documents we have published, this document will be reviewed and updated based on the most current industry and regulatory practices. This paper establishes a process for ensuring supply chain security in quality agreements in the following steps:

• Scope
• Structure
• Framing Content
• Technical Content
• Negotiate
• Review
• Signature

This audit manual provides an approach for GMP auditing and self-assessment of pharmaceutical manufacturers, contract manufacturers and laboratories for data integrity elements. This includes the manufacture and testing of human and veterinary medicinal products regulated by FDA, intermediates, active pharmaceutical ingredients (APIs), excipients and raw materials critical to product quality. The target audience for the audit manual is GMP auditors and stakeholders including those who have limited experience with data governance and data integrity expectations and enforcement practices.

This audit manual addresses the integrity and trustworthiness of GMP records within the regulated pharmaceutical industry. This includes the manufacture and testing of human and veterinary medicinal products regulated by FDA, intermediates, active pharmaceutical ingredients (APIs), excipients and raw materials critical to product quality. Audits of software vendors are not within the direct scope of this manual.

GMP Audit Manual [DOWNLOAD]

Understanding the Threat of Illicit Medicines: An Overview of Counterfeit, Tampered, Unapproved and Diverted Pharmaceuticals

The Threat of Illicit Medicines (2 Parts) [DOWNLOAD]

Illicit medicines are a global concern for patients, healthcare professionals, regulators, and manufacturers. For the purposes of this paper, illicit medicines are defined to include counterfeit, tampered, unapproved and diverted drugs.

• Counterfeit Medicines are made or altered by a party other than the manufacturer with intent to deceive. They are not equivalent to the genuine product in safety, efficacy, and quality. At best, they are of unknown composition and may be ineffective, and at worst harmful to patients.
• Tampered Medicines are defined as medicines that have been intentionally and improperly altered without the knowledge of the product’s owner or eventual user.
• Unapproved Medicines are drug products that have not been approved by a country’s health authority for product quality and efficacy or patient safety.
• Diverted Medicines are redirected from the manufacturer’s intended area of sale or destination to a different geography or distribution channel. They may be genuine but may not have the properties that doctors/pharmacists expect (if they are imported products) and may be subject to mishandling and inappropriate storage conditions that may impact product quality. They typically contain packaging and information leaflets in foreign languages for foreign markets that are not approved by the local health authority and are considered misbranded.

Considering that patient safety is the priority for the industry, pharmaceutical manufacturers should have a process dedicated to the identification and prevention of illicit medicines in the marketplace. This document provides a general overview of the definitions, sourcing, and distribution of illicit medicines in the finished form that enable pharmaceutical companies and other supply chain partners to have a foundational understanding of this issue, and aid in their ability to detect, deter, and to establish appropriate controls for Illicit Medicines in the supply chain. This document is meant to provide a basic understanding but does not seek to provide exhaustive or detailed guidance.

The Threat of Illicit Medicines (2 Parts) [DOWNLOAD]

Responding to the Threat of Illicit Medicines Methodologies for Monitoring, Investigation & Stakeholder Engagement

Patient safety is the highest priority for industry, therefore pharmaceutical manufacturers should have processes and capabilities dedicated to identifying and detecting illicit medicines and preventing their distribution. This document provides a high-level summary of Supply Chain Security (SCS) practices and tools that pharmaceutical companies, and other supply chain partners, can use to help detect, deter, and prevent the distribution of illicit medicines. This document is meant to provide a basic understanding but does not seek to provide detailed guidance.

Illicit medicines are often distributed through unauthorized channels or illicit markets. They can also be inserted into legitimate distribution channels. Many illicit products are distributed through online sellers such as trade boards, individual ads listings, online pharmacies, social media apps; and illegitimate physical supply chain outlets such as flea markets/body builder networks and health/nutraceutical stores. They can also be sold through legitimate sources where the buyer is unaware that they are buying
illicit products. Different illicit product types may be mixed.