Tag Archives: CGMP

FDA Finalizes Guidance on “Small Business” Definition under CGMP and Preventive Controls Regulations for Human and Animal Food

  The FDA Food Safety Modernization Act’s (FSMA) Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-based Preventive Control (HARPC) provisions for human and animal food are implemented by FDA under 21 C.F.R. Part 117 and Part 507, respectively.  Meeting the “small business” definition has two main implications: (1) Certain small businesses (i.e., “farm mixed-type … Continue Reading

FDA Issues Draft Guidance on Produce Safety Requirements under FSMA

FDA has published two draft guidance documents to assist processors and farmers in complying with product safety requirements under the Food Safety Modernization Act (FSMA). The FSMA final rule on Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls (HARPC) for Human Food (the Preventive Controls Rule) was published on September 17, 2015 (80 … Continue Reading

FDA Explains What to Expect As Compliance Date Nears for PC Animal Food Rule

On August 14, 2018, FDA released a constituent update regarding the upcoming compliance dates for the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule under the Food Safety Modernization Act (FSMA). By September 17, 2018, both large and small animal food facilities must comply with preventive controls … Continue Reading

FDA Issues First Warning Letter for Alleged HARPC Violations

On July 26, 2018, FDA posted its first Warning Letter citing Kerry, Inc. for alleged violations of the Hazard Analysis and Risk-Based Preventive Controls (HARPC) and Current Good Manufacturing Practice (CGMPs) provisions at 21 CFR Part 117. While FDA has cited violations of the revised CGMP regulations in prior Warning Letters, this appears to be … Continue Reading

FDA Survey of the Cosmetics Industry on Current Manufacturing Practices

The U.S. Food and Drug Administration (FDA) announced yesterday, July 2, 2018, an opportunity for public comment on a proposed survey of the manufacturing practices and standards employed across the cosmetic industry to ensure product quality and safety. The survey is intended to provide the industry with a systematic and detailed study of the current … Continue Reading

FDA Releases Guidance Documents Concerning Animal Food CGMPs and the FSMA “Solely Engaged” Exemptions

As previously covered on this blog, the Final Rule for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, 80 Fed. Reg. 56170 (Sept. 17, 2015) under the Food Safety Modernization Act (FSMA) became effective on November 16, 2015.  Covered large and small businesses are now required to be in compliance … Continue Reading

We and our analytics and advertising providers may use cookies and similar technologies to enhance the browsing experience, facilitate sharing of content, and generate statistics about use of the website. For more information or to change your preferences, click here.

I Agree