USFDA norms on changes to disposable manufacturing materials to bring more clarity to processes

Bengaluru, August 13, 2022 :

Indian pharma sees that the US FDA norms on Changes to Disposable Manufacturing Materials will bring more clarity during submissions for approvals. This guidance describes chemistry, manufacturing, and controls (CMC) and post approval changes related to disposable manufacturing materials that applicants can pursue in drug and biological product manufacturing.

Changes to disposable manufacturing materials can include, but are not limited to replacement of suppliers, with or without a change in product-contacting material. It covers using similar materials that differ in composition or design, reducing the number of materials used or extending the use of materials in manufacturing by increasing throughput and reusing a disposable manufacturing material.

The regulatory authority noted that the guidance applies to biologics license application (BLA) products human drug products marketed as new drug applications (NDAs) or abbreviated new drug applications and veterinary drugs marketed as new animal drug applications (NADAs) or abbreviated new animal drug applications (ANADAs). Further the guidance applies to all manufacturing establishments, including those that perform functions under contract as defined in the guidance for industry Contract Manufacturing Arrangements for Drugs: Quality Agreements.

“We have been receiving questions about the limited availability of disposable manufacturing materials during periods of increased demand like for instance public health emergencies or natural disasters. Limited availability of disposable manufacturing materials can affect sterile drugs and biological products. Applicants should use science-based and risk-based principles, and refer to current guidance for industry, to determine the appropriate reporting category to communicate changes to disposable manufacturing materials,” said FDA in its guidance.

In order to ensure total adherence FDA expects all changes to be appropriately managed by an establishment’s pharmaceutical quality system under the statutory requirements and applicable current good manufacturing practice (CGMP) regulations.

Factors to be considered when assessing risks to product quality and determining the reporting category for the change include the intended use of the disposable manufacturing material in the manufacturing process. It covers whether a disposable manufacturing material is used upstream or downstream. The use of redundant steps within the manufacturing process and enhanced product and process knowledge gained since application approval. Also whether in-process and release-stability controls meet current regulations for detecting differences in product quality attributes; and (6) the extent of existing validation data.

A comparability protocol (CP) could be used as a tool for making changes to disposable manufacturing materials because a change to one material can be implemented to many products. An approved CP can be used for a one-time change or be used repeatedly for a specified type of change over the lifecycle of a product, said the regulatory authority.

The pharma industry, applicants needs to review existing regulations for it to determine the appropriate reporting category for a proposed change. This because the regulatory authority said that the examples in guidance are not comprehensive and may not address novel situations. Hence the applicants should contact the regulator for feedback on a proposed change, especially before submitting a supplement with a lower reporting category than what is required in existing regulations.

Indian companies appreciate the guidance and the considerable in-depth information when the current scenario demands disposable manufacturing materials like single-use technologies like bags tubing and process equipment. PhamaBiz