Summary: AAMI TIR48 provides guidance for manufacturers of combination products to comply with FDA CGMP regulations. It offers a comprehensive resource for navigating complex regulatory environments, focusing on streamlined compliance, management responsibilities, design controls, risk management, and inspection readiness.

Key Takeaways:

  • AAMI TIR48 helps manufacturers streamline compliance with FDA CGMP regulations for combination products.
  • The guidance covers essential aspects like management responsibilities, risk management, and inspection readiness.

A brand-new guidance document, AAMI TIR48, released by the Association for the Advancement of Medical Instrumentation (AAMI), will assist manufacturers in aligning with the latest best practices for manufacturing combination products.

AAMI TIR48: 2024 Quality management systems (QMS) recommendations on application of the U.S. FDA’s CGMP final rule on combination products is designed to assist manufacturers in complying with the FDA’s regulation on current good manufacturing practices (CGMPs) for combination products.

Combination products are defined as products that incorporate drugs or biologics with medical devices. However, the taxonomy and regulations surrounding these products may vary wildly from country-to-country, leading to confusion for manufacturers looking to stay compliant with U.S. requirements.

Comprehensive Resource for Manufacturers

AAMI TIR48 provides a comprehensive resource for manufacturers navigating FDA requirements for combination products and ensuring they can bring medical devices to market that will benefit patients. AAMI TIR48:

  • Assesses FDA’s codified ‘Streamlined Approach’ for compliance with CGMPs and identifies manufacturer considerations.
  • Provides a clause-by-clause assessment of the pertinent sections of 21 CFR and identifies compliance pathways.
  • Addresses viable alternative and streamlined mechanisms for complying with CGMPs.
  • Compiles management responsibilities for manufacturers of combination products, addressing aspects such as executive oversight, quality policy, risk based QMS, auditing, and more.
  • Applies design controls and risk management to combination products.
  • Includes information on purchasing controls, corrective and preventive action (CAPA), and inspection readiness for manufacturing facilities.

Expert Contributions to AAMI TIR48

AAMI TIR48 was produced by the AAMI Combination Products Committee, which is co-chaired by John Weiner, director of the office of global operations at the FDA and Susan Neadle, an industry veteran and leading expert in the field of combination products.

“Sometimes you’re using the exact same words for the drug world as you use in the device world, but the interpretation is different,” said Neadle. “That creates all sorts of confusion not just for industry but also for health authorities. So, the inspection readiness piece of TIR48 will help you contend with that both internal to your organization and as you’re interfacing with health authorities.”

Latest Industry Guidance

AAMI TIR48 provides the most current industry guidance for combination products manufacturers as they deal with an increasingly complex regulatory environment. The standard is available for purchase in the AAMI store.