In drug manufacturing, keeping track of data is crucial for the drug’s approval from the FDA. The “Continued Process Verification” (CPV) data needs to be maintained for ensuring that the product outputs are within predetermined quality limits…
https://kenx.org/wp-content/uploads/2020/09/Screen-Shot-2020-09-23-at-11.24.32-AM.png271752Evan HThttps://kenx.org/wp-content/uploads/2020/07/Insights-Logo22-1.pngEvan HT2020-09-23 15:23:242020-09-23 19:37:40CPV Batch Record Digitization: Challenges and Role of AI
A big reshuffle has been made in one of the principal guidelines for Commissioning & Qualification (C&Q) within the pharmaceutical industry today. The changes seek to improve the application of Quality Risk Management (QRM), a growing element of regulatory expectation…
https://kenx.org/wp-content/uploads/2020/08/insight-photo.png293766Evan HThttps://kenx.org/wp-content/uploads/2020/07/Insights-Logo22-1.pngEvan HT2020-09-02 14:35:342022-01-18 21:46:14The Big Reshuffle — Impact Assessments and System Criticality
Since the publication of ICH Q9[1] in 2005, the pharmaceutical industry is encouraged to take a risk-based approach to the control and management of product quality. The expectation that Quality Risk Management (QRM) is integrated into the Pharmaceutical Quality System (PQS) is further developed in ICH Q10 [2]. ICH Q10 objectives are to achieve…
https://kenx.org/wp-content/uploads/2020/07/unnamed.png4861128rculverhttps://kenx.org/wp-content/uploads/2020/07/Insights-Logo22-1.pngrculver2020-07-07 15:10:002020-07-30 05:13:21Risk Management Tied Up With A Bow Tie
CPV Batch Record Digitization: Challenges and Role of AI
In drug manufacturing, keeping track of data is crucial for the drug’s approval from the FDA. The “Continued Process Verification” (CPV) data needs to be maintained for ensuring that the product outputs are within predetermined quality limits…
The Big Reshuffle — Impact Assessments and System Criticality
A big reshuffle has been made in one of the principal guidelines for Commissioning & Qualification (C&Q) within the pharmaceutical industry today. The changes seek to improve the application of Quality Risk Management (QRM), a growing element of regulatory expectation…
Risk Management Tied Up With A Bow Tie
Since the publication of ICH Q9[1] in 2005, the pharmaceutical industry is encouraged to take a risk-based approach to the control and management of product quality. The expectation that Quality Risk Management (QRM) is integrated into the Pharmaceutical Quality System (PQS) is further developed in ICH Q10 [2]. ICH Q10 objectives are to achieve…