Combination Products Regulatory Expectations and the FDA’s Latest Codification of the Applicable cGMP Requirements

Historically, the absence of clear cGMP requirements for Combination Products has resulted in the inconsistent application as to the applicable Agency Center to submit products for review. Products for both CDER and CBER as the primary Agency contact point may have historically been submitted to the incorrect organization for review because of a lack of knowledge as to the Primary Mode of Action (PMOA) of the product. While some of these product applications might have been relatively easy to discern, e.g., a pre-filled syringe (usually CDER), other products may have had great difficulty finding the “correct home”. In October 2004, the FDA issued a Draft Guidance for Industry entitled “Current Good Manufacturing Practice for Combination Products”. NINE years later, the FDA CODIFIED the cGMP requirements applicable to combination products. This rule is intended to promote public health by clarifying which cGMP requirements apply when drugs, devices, biological products, and human cell and tissue products (HCT/Ps) are combined to create a combination product. This permits both a client company and the FDA to move the product through the regulatory system most efficiently. The new rules also discuss a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with cGMP requirements for single-entity and co-packaged combination products.

The objective of this session is to explore this new rule and guidance for the industry as they apply to your organization and examine options for obtaining compliance within a cGMP framework.

Learning Benefits:-

• The latest cGMP Requirements for Combination Products.
• Clarification of the cGMP Requirements that apply to Combination Products.
• Ensuring the Consistent and Appropriate Application of these Requirements.
• Examination of the various Guidances for Industry.
• Determining the Primary Mode of Action (PMOA).
• Learning how to Streamline the Practical Implementation of cGMP Requirements.
• Ensuring that cGMPs for Co-Packaged and Single-Entity Combination Products are Consistent and Appropriate without Duplication.
• Determining what new cGMP Requirements may be required.

Outline:-

• Introduction
• Definitions
• Combination Products – Codification of Rules
• Combination Products – What are they
• Examples of Combination Products
• Products – Primary Mode of Action (PMOA)
• Designations, Assignments, and Miscellaneous
• The Guidance for Industry
• Europe – MHRA

Who Should Attend:-

The following individuals will benefit from attending this session:

• Quality Assurance personnel
• Quality Control personnel
• Research & Development
• Regulatory Affairs Professionals
• Validation
• Legal
• Those that use contract manufacturing and contract testing facilities
• Auditors