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[…]
Subsystems interacting with The Design Control Process Management Controls Production and Process Controls Corrective and Preventive Action Document and Record Control Labeling and Packaging Control Risk Management Change Control QSIT Design control requirements Your Firm must have a 21 CFR 820.30 compliant design control process prior to submitting a 510(k), as well as during IDE Read more about FDA expectation from you during Design Control portions of Inspections[…]
Regulatory and Guidance Documents •2006 FDA Guidance for Industry – Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production. •ICH Q6A •ICH Q7A •USP 31 <1117> Best Microbiological Practice •Addressed in PMF Newsletter (Sutton and Settineri) http://www.microbiologyforum.org/PMFNews/PMFNews.12.11.0611.pdf (Sutton) http://www.microbiologyforum.org/PMFNews/PMFNews.13.06.0706.pdf (Settineri) •Addressed in PDA Draft Technical Report Points to Consider When Investigating Microbiological Data Deviations Read more about What are the guidance documents that govern MDDs?(Microbial Data Deviation Investigations)[…]
Following are the key things you should look for pre approval inspection. Deviations, OOS, product failures Investigations and CAPA’s Label control QA oversight Management oversight Drug Safety and Pharmacovigilance projects Process, shipping cleaning method Vendor and contractor qualification and oversight Deviations gives the indication of break down in one or all of the following:Equipment, processes, SOP’s, Read more about Pre Approval Inspection and things to look for[…]
JPAL Laws, Ordinances and Notifications (relevant to GCP audits & the foreign manufacturer) The Pharmaceutical Affairs Law (Law No. 145 Established as of August 10, 1960; Law No. 87 Revised as of July 26, 2005)MHLW Ministerial Ordinance No. 36 Clinical Tests for Medical Devices (hereinafter referred to as “Medical Device GCP” or “JGCP”)YAKUSHOKUKIHATSU No. 0720005 Read more about Basics of Japanese Medical Device GCP (JGCP)[…]