FDA Consulting: Drug Shortages

A landmark FDA consulting article in Pharmaceutical Technology, “Linking Drug Shortages and Quality Metrics” provided information regarding the link between drug shortages including the enactment of the Food and Drug Administration Safety and Innovation Act,
 

FDA Drug Shortage List

 

FDA’s efforts to develop a common set of quality metrics for the pharmaceutical industry will help address the current drug shortage problem. Efforts from the industry to establish and maintain quality metrics capable of measuring the suitability of pharmaceutical products for the patient, and the capability of the manufacturer to consistently provide these products without delay will increase knowledge.
 
The Parenteral Drug Association (PDA) also published Technical Report No. 68 (TR68), “Risk-Based Approach for Prevention and Management of Drug Shortages,” which provides the bio/pharmaceutical industry with appropriate tools for preventing drug shortages.
 

FDA Drug Shortages

 

PDA technical reports, authored and peer-reviewed by PDA members, are intended to offer practical guidance on pertinent regulatory and scientific topics that affect the global pharmaceutical industry. Members with expertise in manufacturing and quality assurance for sterile biopharmaceutical and pharmaceutical products (the majority type of products subject to drug shortages) authored TR68.

 

Although PDA technical reports are not officially recognized guidance, they are often referenced by FDA consulting experts and regulators. Additionally, regulators may be involved in the writing or approving of the final report contents.

 

Product Shortages

 

TR68 addresses the drug shortage issue from a global perspective and offers relevant, proactive advice applicable to the global pharmaceutical industry. In addition, the paper recognizes several contributing factors potentially responsible for drug shortages: manufacturing issues, quality issues, and supply chain or distribution issues. This is important because TR68 recognizes that the issue of a potential drug shortage goes beyond the quality department within an organization.

 

Global Language for Global Issue

 

The document provides a common language for the industry to use when discussing drug shortages. It is this author’s opinion that it is always important when authoring potential global guidance to establish a common language for the readers. TR68 accomplishes this objective by placing a glossary at the beginning of the report and references, when possible, existing FDA consulting definitions from recognized, credible sources.

 

The definition for “harm” for example, is taken verbatim from the International Conference on Harmonization’s (ICH) Q9 guideline, Quality Risk Management. The definition of knowledge management is taken from ICH Q10 Pharmaceutical Quality Systems. Using previously established definitions helps the global users of TR68 understand the context and relationship of this document within the regulatory framework of the industry. 

 

FDA Shortage List

 

Once a common language is established, it is easier for a document user to relate the narrative portion of the document to the shortage list. The narrative of the technical report describes how the issue of drug shortages is global in nature and delineates current global regulatory and legal manufacturer reporting requirements when facing issues that may result in drug shortages. These issues are not limited to final product manufacturers but may involve suppliers of raw materials crucial for product formulation.

 

For example, TR68 describes how a supply-chain issue, a shortage of acetonitrile in 2008-2009, can prompt a drug shortage. The FDA consulting document discusses how multiple suppliers were unable to provide acetonitrile to the industry because of a series of unforeseen circumstances. This shortage impacted the ability of companies to manufacture APIs that then impacted the manufacture of the final drug product.

 

Drug Shortage List

 

The document is designed to guide bio/pharmaceutical companies in the assessment of the risk of experiencing a drug shortage. TR68 uses a risk triage model to collect and assess existing organizational information to determine drug-shortage risk. The model builds on the concepts of management responsibility, supply chain management, quality risk management, knowledge management, regulatory requirements and a company’s compliance history and treats them as integrated interrelated disciplines within an organization.

 

The examples included in the document provide templates to combine a company’s information into a comprehensive set of tools that not only measure the potential for a company to experience a drug shortage, but also delineate and identify gaps in organization structure that may exist in quality systems.

 

Medication Shortages

 

The document takes the aforementioned concepts and provides a framework for capturing the information in one inclusive document. This can help remedy issues with resolving medication shortages and patient wait times. The completed document can be used as a FDA consulting tool to share within an organization or with clients in determining potential process improvements or necessary resources required to address systemic process gaps.

 

TR68 can be used in part or in total by raw material and API suppliers, contract manufacturing organizations, and pharmaceutical companies to assess and manage organizational, manufacturing, and quality issues that could contribute to a drug shortage. The document provides tools to predict and hopefully prevent drug shortages in the future.

 

Article Details:

 

regulatory compliance

 

Pharmaceutical Technology
Vol. 39, Issue 3
Pages: 26–27 

 

About RCA FDA Consulting Services

 

Regulatory Compliance Associates (RCA)® has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, RCA offers leading pharmaceutical consultants that can help you navigate through the challenges associated with evolving industry regulations.

 

Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, RCA® Inc. will guide you through every step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At RCA® Inc., we offer the experience and resources necessary to guide you in quality compliance.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness

 

Quality Assurance

 

Regulatory Compliance Associates® Inc.’s Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • FDA Consulting

 

Remediation 

 

Regulatory Compliance Associates® Inc. has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute.

 

We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

 

  • Regulatory Action
  • FDA Consulting
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

About RCA

 

Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

Our website uses cookies to give you the best possible experience.

By continuing to use this site, you agree to the use of cookies.
Continue
Privacy Policy