Comparability Protocols for postapproval changes to the chemistry, manufacturing, and controls information in an NDA, ANDA, or BLA: guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biological Products Drug Approval Government Regulation United States United States. Food and Drug Administration
- Genre(s):
- Guideline Technical Report
- Abstract:
- This final guidance is intended to assist original applicants and holders of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) with implementing a chemistry, manufacturing, and controls (CMC) postapproval change through the use of a comparability protocol (CP). A CP is a comprehensive, prospectively written plan for assessing the effect of a proposed postapproval CMC change(s) on the identity, strength, quality, purity, and potency of a drug product, including a biological product (i.e., product), as these factors may relate to the safety or effectiveness of the product (i.e., product quality). Submission of a CP in an original application or in a prior approval supplement (PAS) to an approved application allows FDA to review a description of one or more proposed CMC postapproval changes, any supporting information and analysis, including a risk assessment, a plan to implement the change(s), and, if appropriate, a proposed reduced reporting category for the change(s). Approval of the original application or a subsequent PAS containing the CP provides an agreed-upon plan to implement the specified change(s), and in many cases, a justification to report the change(s) in a reduced reporting category, contingent upon your analysis of the data from the implementation of the change(s). In many cases, submission and approval of a CP will facilitate the subsequent implementation and reporting of CMC changes, which could result in moving a product into distribution or facilitating a proactive approach to reinforcing the supply of the product sooner than if a CP were not used. The drivers for such changes include business needs, expanding markets, process improvements, potential for drug shortage, and accelerated manufacturing development that sometimes occurs with drugs eligible for expedited programs. This guidance recommends a framework to promote innovation and continuous improvement in the manufacturing of quality products by encouraging you to employ: (1) Effective use of knowledge and understanding of the product and manufacturing process (2) Risk management activities over the life cycle of a product (3) An effective pharmaceutical quality system. This guidance applies to CPs submitted in NDAs, ANDAs, BLAs, and supplements to these applications regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). However, this guidance is not applicable to blood and blood components; biological products that also meet the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); or human cells, tissues, or cellular or tissue-based products (HCT/Ps) regulated solely under section 361 of the Public Health Service Act and 21 CFR part 1271. Recommendations for the use of CPs by manufacturers of licensed blood and blood components are included in a separate FDA guidance for industry on Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture (December 2014). The scope of this guidance does not include animal drugs.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (ii, 28 pages))
- NLM Unique ID:
- 9918504288606676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918504288606676