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Standards development and the use of standards in regulatory submissions reviewed in CBER | HartmannWillner

By Nitisha Pyndiah, PhD

In a draft guidance document released on December 2017, FDA described CBER’s recommendations on the use of standards in product development and the use of such standards in CBER’s managed review process. Mainly, FDA promotes international harmonization of standards acceptable to FDA.

As the use of standards can greatly facilitate a sponsor’s product development and allow a more efficient evaluation of regulatory submissions, I propose to summarize the guidance for you.

 

How to describe standards?

Standards are described by FDA as integral to the execution of FDA’s mission. Standards are defined as common and repeated use of rules, conditions, guidelines etc, they also include the definition of terms, classification of components and delineation of procedures etc and terminology, symbols, labeling requirements as they apply to a product, process or product method. This means that activities that would need the use of standards are:

• The development of performance characteristics

• Testing methodology

• Manufacturing practices

• Product standards

• Scientific protocols

• Compliance criteria

• Ingredient specifications

• Labeling or

• Other technical or policy criteria

Standards are not regulations as they are voluntary unless mandated by regulation or statute. Standards are developed by organizations often outside of the federal government (those are called SDO: standard development organization). The United States Pharmacopeial Convention (USP), American Society for Testing and Materials International (ASTM) and International Organization on Standardization (ISO)) are examples of SDOs.

Voluntary Consensus Standards are on type of SDO, and are standards developed or adopted by a domestic or international voluntary consensus standards body. A voluntary consensus standard development includes the following attributes or elements:

• Openness

• Balance

• Due process (should include documented and publicly available=

• Appeals process (available for the impartial handling of procedural appeals)

• Consensus (general agreement)

Intellectual property policies may apply to voluntary consensus standards bodies.

SDOs development standards for the development of performance characteristics, testing methodology, manufacturing practices, product standards, scientific protocols, compliance criteria, ingredient specifications, labeling, and terminology.

 

The development of standards

SDOs use different methods to develop standards, but the process normally begins with the following:

• Identify the need for a written/documentary standard or a material/physical standard

• Gather experts to develop the standard

• Drafts of written standards are circulated for comment, voting, editing and publishing

CBER staff often take part in the development of standards but CBER clarifies that their participation in the development of a particular standard does not mean that they endorse the latter.

 

CBERs advice for sponsors and applicants using standards in support of their IND or BLA

Provide a complete reference for the standard used in the regulatory submission

• If CBER deemed that a version of a standard is acceptable, the sponsor should not use an updated version of the standard without discussing with the product office

• “A sponsor may use appropriate written/documentary standards that describe a process or assay used to assess a manufacturing intermediate or final product”

• “A sponsor may also utilize an appropriate physical standard or reference material in the development and testing of their product” e.g. reference standards obtained from reputable commercial source/ other materials of documented purity certified by an analytical laboratory. “CBER recommends providing the source and lot number, expiration date, certificates of analyses when available, and/or internally or externally generated evidence of identity and purity for each reference standard”

• Data standards may promote efficient review of regulatory submission (e.g. Structured Product Labeling (SPL)) see the FDA Data Standards Catalog, available here. 

Although standards are mostly voluntary, they may allow your drug development to be faster and more efficient reducing the need to develop unique methods and reference materials for individual products.