This article not only applies to high potent (HP) active pharmaceutical ingredient (API) manufacturing, but it also includes pharmaceutical manufacturing products with HP APIs; therefore, the term “HPAPI manufacturing” and “HPAPI product” applies to both types of production.
Product complaints and reports of adverse events are unwelcome events at any company, especially if a product recall must be considered. However, these must be handled promptly and with all due diligence to prevent authentic drug-related events from negatively impacting the health and well-being of patients. 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. Please note that the example serious adverse event and product complaint is described in a high-level manner to protect confidentiality of the patient, hospital and company involved.
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
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 HT2023-04-28 18:36:172023-09-14 15:14:52Paper 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 to progress research on quality risk management (QRM), knowledge management (KM) operational excellence (OpEx), post-approval change management (PAC, and PAC 1VQ), quality metrics and related topics covered by ICH Quality Guidelines.
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 to progress research… see attached
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 HT2023-04-28 18:28:282023-09-14 15:17:23Paper 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… see attached
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 16:44:042023-09-14 15:15:18Paper 1: Improving Risk-Based Decision Making Effectiveness: Insights From Other Industries
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 18:59:402022-08-31 22:06:55Innovative considerations for efficient multi-(product) use of Protein-A columns
Stability excursions are unintended lapses in the control parameters (such as temperature, relative humidity, and light) which are designed to preserve a product at experimental, manufacturing, shipping, and patient environment conditions. Significant excursions bring into doubt the validity of data generated in stability studies and the integrity of product during manufacturing and distribution…
STAGE 1: HIGH POTENT ACTIVE PHARMACEUTICAL INGREDIENT (HPAPI) CLEANING VALIDATION (CV)
PRODUCT COMPLAINTS AND ADVERSE EVENTS
Paper 4: Improving Risk Based Decision Making Effectiveness: Addressing Uncertainty
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 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 to progress research on quality risk management (QRM), knowledge management (KM) operational excellence (OpEx), post-approval change management (PAC, and PAC 1VQ), quality metrics and related topics covered by ICH Quality Guidelines.
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 to progress research… see attached
Paper 1: Improving Risk-Based Decision Making Effectiveness: Insights From Other Industries
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…
Medical Product Excursions from Labeled Storage Conditions
Stability excursions are unintended lapses in the control parameters (such as temperature, relative humidity, and light) which are designed to preserve a product at experimental, manufacturing, shipping, and patient environment conditions. Significant excursions bring into doubt the validity of data generated in stability studies and the integrity of product during manufacturing and distribution…