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Regulatory Focus™ > News Articles > 2019 > 2 > CDER Proposes Program to Create Voluntary Pharmaceutical Quality Standards

CDER Proposes Program to Create Voluntary Pharmaceutical Quality Standards

Posted 13 February 2019 | By Zachary Brennan 

CDER Proposes Program to Create Voluntary Pharmaceutical Quality Standards

With an aim to promote innovation in pharmaceutical development and manufacturing, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday released draft guidance to begin the process of creating a program on voluntary consensus standards related to pharmaceutical quality.

Although the 7-page draft guidance does not offer examples of what such standards would look like, it does describe how the use of a recognized standard has the potential to streamline the compilation and review of marketing applications at CDER.

“Once we’ve recognized a standard, applicants will generally not have to validate the approach outlined in the standard and can instead focus on appropriate use of the method and the acceptance criteria. We’ll similarly be able to streamline assessment of applications that reference recognized standards. Our hope is that establishing this program will also encourage the development of standards for emerging technologies that can improve drug quality and reduce manufacturing costs. This includes continuous manufacturing,” FDA Commissioner Scott Gottlieb said.

And unlike the formal recognition standards program in FDA’s Center for Devices and Radiological Health, this CDER program will be informal, and the draft guidance notes how even if an applicant uses one of the voluntary standards, CDER may request additional information to support an investigational new drug (IND) application or a marketing application.

But industry may raise concerns with certain aspects of the program as companies have previously taken issue with FDA’s attempt to create a quality metrics program. Although more recently, FDA has launched two other new programs to gather feedback on the use of quality metrics and to provide ways for industry to engage the agency and inform FDA’s use of quality metrics.

As far as how this voluntary consensus standard program will be built, after considering comments on this draft guidance, CDER’s Pharmaceutical Quality Standards Working Group (PQSWG) intends to develop an internal process for informally recognizing standards in whole or in part, and document this process in a publicly available Manual of Policies and Procedures.

And if the voluntary consensus standard meets certain PQSWG qualifying criteria, the working group:
  • May recommend the formation of a subgroup of subject matter experts to review a standard, and when necessary, PQSWG should work with relevant experts within organizational units impacted by the technical content of the standard.
  • May also recommend that an FDA laboratory evaluate the proposed standard.
  • Will work in collaboration with subject matter experts to prepare the information sheet describing the scope and the extent of CDER’s informal recognition of that standard and any other relevant information about that standard.
“CDER proposes to maintain a listing of informally recognized voluntary consensus standards related to pharmaceutical quality on a searchable database that may be accessed via CDER’s public website. On that website, an information sheet should accompany every recognized standard,” the draft adds.

“While this program is intended for all drugs, brand and generics, we know that it will have a positive effect in supporting more efficient development and production of generic drugs, which often operate under small margins compared to brand drugs. Creating efficiencies in generic and biosimilar manufacturing is an important part of our work to streamline generic and biosimilar development overall,” Gottlieb added.


Gottlieb also explained how the framework within the International Council for Harmonisation’s (ICH) Q12 guidance, once finalized, will allow applicants to gain agreement with FDA on the established conditions (ECs) necessary to ensure product quality, and to facilitate post-approval changes to those established conditions.

“Examples of ECs can include manufacturing and testing facilities, and certain process parameters and specifications. Tomorrow, we’ll announce the details of a new pilot program to gain experience receiving, assessing, and engaging with applicants regarding proposed ECs (also referred to as ‘explicit’ ECs). Once the ICH Q12 guideline is finalized and implemented, the use of ECs is intended to help reduce submissions of unnecessary postapproval supplement applications and encourage manufacturers to continually improve their processes using the agreed-upon ECs as their guardrails,” he added.

CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality: Draft Guidance for Industry

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