This article not only applies to high potent (HP) active pharmaceutical ingredient (API) manufacturing, but it also includes pharmaceutical manufacturing products with HP APIs.
This article provides an overview of the receipt, investigation and categorization of product complaints. An example of a product complaint triggered by a serious adverse event is also described.
The Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches… see more
https://kenx.org/wp-content/uploads/2020/07/webinar-6-scaled.jpg18282560Evan HThttps://kenx.org/wp-content/uploads/2020/07/Insights-Logo22-1.pngEvan HT2023-04-28 16:44:042024-01-26 15:56:20Paper 1: Improving Risk-Based Decision Making Effectiveness: Insights From Other Industries
The Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches.
https://kenx.org/wp-content/uploads/2023/04/selective-focus-of-laptop-with-blank-screen-near-b-2022-12-16-17-42-29-utc-scaled.jpg17072560Evan HThttps://kenx.org/wp-content/uploads/2020/07/Insights-Logo22-1.pngEvan HT2023-04-26 18:28:282024-01-26 15:57:28Paper 2: Improving Risk Based Decision Making Effectiveness: A Case For Risk Decision Review Points (KDRPS) In The Quality Risk Management Process
The Pharmaceutical Regulatory Science Team (PRST) founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing Science and Risk based decision making and manufacturing approaches. Since its inception, the PRST has continued… see attached
https://kenx.org/wp-content/uploads/2023/04/stationery-and-cup-of-coffee-on-wooden-table-2021-08-31-17-21-03-utc-scaled.jpg15052560Evan HThttps://kenx.org/wp-content/uploads/2020/07/Insights-Logo22-1.pngEvan HT2023-04-25 18:36:172024-01-26 15:59:23Paper 3: Improving Risk Based Decision Making Effectiveness: Determining The Level Of Formality
The Pharmaceutical Regulatory Science Team (PRST) founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing Science and Risk based decision making and manufacturing approaches.
In traditional monoclonal antibody (mAb) manufacturing, the first purification process step of crude harvest (obtained from cell culture) is Protein-A Chromatography. This expensive column resin is often under-utilized for clinical or orphan drug products since the chromatography columns are dedicated per product…
In traditional monoclonal antibody (mAb) manufacturing, the first purification process step of crude harvest (obtained from cell culture) is Protein-A Chromatography. This expensive column resin is often under-utilized for clinical or orphan drug products since the chromatography columns are dedicated per product…
In traditional monoclonal antibody (mAb) manufacturing, the first purification process step of crude harvest (obtained from cell culture) is Protein-A Chromatography. This expensive column resin is often under-utilized for clinical or orphan drug products since the chromatography columns are dedicated per product…
https://kenx.org/wp-content/uploads/2022/05/Insight-Chart.png371808Evan HThttps://kenx.org/wp-content/uploads/2020/07/Insights-Logo22-1.pngEvan HT2022-05-19 18:59:402024-01-26 16:03:59Innovative considerations for efficient multi-(product) use of Protein-A columns
Stability considerations for drug-device combination products-21 CFR part 4 update
STAGE 1: HIGH POTENT ACTIVE PHARMACEUTICAL INGREDIENT (HPAPI) CLEANING VALIDATION (CV)
PRODUCT COMPLAINTS AND ADVERSE EVENTS
Paper 1: Improving Risk-Based Decision Making Effectiveness: Insights From Other Industries
Paper 2: Improving Risk Based Decision Making Effectiveness: A Case For Risk Decision Review Points (KDRPS) In The Quality Risk Management Process
The Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches.
Paper 3: Improving Risk Based Decision Making Effectiveness: Determining The Level Of Formality
The Pharmaceutical Regulatory Science Team (PRST) founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing Science and Risk based decision making and manufacturing approaches. Since its inception, the PRST has continued… see attached
Paper 4: Improving Risk Based Decision Making Effectiveness: Addressing Uncertainty
Cleaning Validation Program Design: Risk-Based Lifecycle Approach
In traditional monoclonal antibody (mAb) manufacturing, the first purification process step of crude harvest (obtained from cell culture) is Protein-A Chromatography. This expensive column resin is often under-utilized for clinical or orphan drug products since the chromatography columns are dedicated per product…
CIP Cleaning Cycle Development Pitfalls and Solutions
In traditional monoclonal antibody (mAb) manufacturing, the first purification process step of crude harvest (obtained from cell culture) is Protein-A Chromatography. This expensive column resin is often under-utilized for clinical or orphan drug products since the chromatography columns are dedicated per product…
Innovative considerations for efficient multi-(product) use of Protein-A columns
In traditional monoclonal antibody (mAb) manufacturing, the first purification process step of crude harvest (obtained from cell culture) is Protein-A Chromatography. This expensive column resin is often under-utilized for clinical or orphan drug products since the chromatography columns are dedicated per product…