Good manufacturing practice considerations for responding to COVID-19 infection in employees in drug and biological products manufacturing
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- 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. Center for Veterinary Medicine (U.S.), issuing body.
- Publication:
- [Silver Spring, MD] : Center for Drug Evaluation and Research, June 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biological Products COVID-19 -- prevention & control Drug Industry Manufacturing and Industrial Facilities United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide recommendations to drug and biological product manufacturers regarding: Manufacturing controls to prevent contamination of drugs, Risk assessment of SARS-CoV-2 as it relates to drug safety or quality, Continuity of manufacturing operations. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)). However, the recommendations described in the guidance are expected to assist the Agency more broadly in its continued efforts to assure the safety and quality of drugs and maintain the drug supply beyond the termination of COVID-19 public health emergency and reflect the Agency’s current thinking on this issue. Therefore, within 60 days following the termination of the public health emergency, FDA intends to revise and replace this guidance with any appropriate changes based on comments received on this guidance and the Agency’s experience with implementation
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (10 pages)).
- NLM Unique ID:
- 9918231204306676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918231204306676