21 CFR 117- FSMA – Current GMPs, Hazard Analysis, and Risk-Based Preventive Controls for Human Food

Posted on March 23, 2021March 23, 2021 by admin

While specifically exempted from Subparts C and G of 117, due to overlap with 111, dietary supplement manufacturers/companies have responsibility for compliance with subparts A (General Provisions), B (cGMPs), and F (Records that must be established and maintained). FSMA spells out an exemption to subpart G, – Supply-Chain Program, but these exemptions apply only Read more about 21 CFR 117- FSMA – Current GMPs, Hazard Analysis, and Risk-Based Preventive Controls for Human Food[…]

What is FMEA and How to Use it ?

Posted on July 13, 2020July 13, 2020 by admin

Failure Modes and Effects Analysis is the subject of an international standard, IEC 60812-Analysis techniques for system reliability-Procedure for failure mode and effects analysis (FMEA) The only international standard that applies for FMEA is IEC 60812, which shows general application, but does not show the use of the tool in risk management.An extension to the Read more about What is FMEA and How to Use it ?[…]