Best Practice #1: Push Quality Upstream• Deploy a web-based system and make it available to outsourcedmanufacturers• They collect quality data and enter real-time into the quality system• Quality data is instantly available to OEM quality engineers• Process metrics are calculated by the system and pushed to qualityengineers every few hours• Benefit: Engineers spend more time Read more about Best practices in supplier Quality[…]
EO Concentration Commonly 400 and 700 mg/l As EO concentration increases at a given temp and RH, –microbial inactivation (kill) rate increases Killing concentration required at the site where the microbes (BI’s) are located Water Vapor (Humidity) Required for EO to react with the critical cell molecules • Generally measured as Relative Humidity Temperature Kill Read more about Four Basic Factors to Microbial Kill[…]
Individually identifiable information collected ormaintained by a Covered Entity – Can be oral or written – Can be in any medium (electronic, printed, recorded) – Includes simple demographic data – just the fact that someone is your patient/plan member is PHI – It’s still PHI if someone could reasonably figure out who the individual subject Read more about What is Protected Health Information (PHI)?[…]
There are many steps in each recall where multiple teams are involved and hence it is very important that each team exactly knows what to do and when to do. Here is a snap shot of all teams involved and at what stpe what need to be done. Notification of a recall Sales and Quality Read more about Food Recall – Each Teams responsibility[…]
The difference between Regulatory and third party audit is at one side regulatory audits are concerned with compliance with code but thrird party audits go beyond codes and evalute the management of food safety systems. A facility can fail in third party audit though it is in compliance with regulatory requirements.Here are list of general Read more about Third party audit in food facility[…]
Building and Grounds should have – -Lights clean and protected -Glass, metal and brittle plastic control -Wooden items eliminated -Adequate lighting in production and storage areas -Floor surfaces clean no water, good condition -Doors pest proof -Dock doors have buffers – Walls in good repair no entry points for pests or harborage -Personal item storage Read more about Building requirements for a Food Audit[…]
The 7 principles applied to HACCP are – Conduct a Hazard analysis -Establish CCPs -Establish critical limits -Establish a monitoring system -Establish corrective action -Verification -Record keeping 5 prelim steps to support the HACCP model – Create the HACCP team -Describe the products -Identify the final users -Create a flowchart of production process -Verify the Read more about HACCP concepts for Food processors[…]
ICH Q9 elements of risk management Risk Identification -> Risk Assessment ->Risk Mitigation -> Risk Communication How to identify risk •Theoretical analysis-Science, engineering, or math•Based on experiments-Structured or unstructured experiments-Edge of failure or validation•Statistically derived-Trend analysis FMEA and HACCP FMEA salient features •How can the process fail?-Power outage stops mixing-Wrong valve open sends product Read more about Risk Management for Bio-Pharma ICH Q8 and ICH Q9[…]