Quality Corner

Date Potent Compound Series
202312  Are Toxicologists Certified <More...>
202301  An OEL from another source, such as a SDS, that is different than the one on the OEL document from professional provider. Which one is correct? <More...>
202212  The equations for both the OEL and ADE seem pretty simple. Can’t I do the literature searches and calculations myself? <More...>
202211  When do you need an OEB vs. an OEL? <More...>
202210  Dos and Donts of OELs and ADEs​ <More...>
202209  What is Chemical Abstracts Service Registry Number(CASRN)?​ <More...>
202206  What  determines  if  a  compound  has  hormonal  activity  and  are  all hormonal compounds highly potent? <More...>
202205  What is driving the increase in HPAPI products? <More...>
Date Cross-contamination Series
202403  Aseptic Manufacturing Practices <More...>
202312  How to create CCS <More...>
202311  EU QP EU GMP Annex 1 CCS FQAs 2020 <More...>
202310  PDA Letter CCS You Have Questions We Have Answers 2021 <More...>
202309  ECA Attachment 1 Example of a Gap Assessment <More...>
202308  ECA Attachment 3 Template for The Contamination CCS Document (example) <More...>
202307  ECA How to Developement CCS <More...>
202305  ASTM E3219 Derivation of HBELs <More...>
202304  ASTM E3106 Science and Risk Based Cleaning Process Development and Validation <More...>
202209  Non-penicillin beta-lactam drugs for preventing cross-contamination <More...>
202207  Cross-contamination in Shared Facilities Guidance by PIC/S goes into force July 1st, 2018 <More...>
Date Track&Trace Series
202311  EMVS Q&A 4 Technical on-bording (Safety features) <More...>
202306  EMVS Q&A 5 Maintenance (Safety features) <More...>
202210  EMVS Q&A 6 Data Upload (Safety features) <More...>
202208  EMVS Q&A 7 CMO and 3PL Connection (Safety features) <More...>
Date CCI Series
202404  CCIT—Practical Aspects and Approaches in the Pharmaceutical Industry <More...>
202303  CCIT- Why Industry Cannot Just “Move Away" from the Dye Ingress Test <More...>
Date Investigation Series
202405  Top 10 DI citations in production systems​ <More...>
202404  A fresh look at an old topic Investigations in the GMDP environment​ <More...>
202402  Do You Make These 8 Big Mistakes In Your Deviation Investigations​ <More...>
202401  Deviation FAQs​ <More...>
Date Other Series
202405  EU MAH GMP Guidance <More...>
202403  EU GMP Annex 11 concept paper on revision 2022 <More...>
202402  Quality culture A top-down culture <More...>
202401  What exactly is Quality Culture <More...>
202309  EMA FAQs of GMDP <More...>
202308  The Moldy Nightmare Questions and Answers, Part 1 <More...>
202302  Top 10 in 2022 <More...>