Visual Inspection Defects in Oral Solid Dosage Forms: Effective Troubleshooting Strategies
Extended Learning
Learning Level: Intermediate
Session Length: 1 hour
This webinar will offer an in-depth insights on mastering AQL and visual inspection defects in oral solid dosage forms, where we’ll equip you with the strategies and tools to ensure top-notch quality in your pharmaceutical production. Learn how to apply Acceptance Quality Limit (AQL) standards to determine defect thresholds and make informed decisions about batch quality. Dive into the identification and categorization of common visual defects in tablets and capsules, with real-world examples to guide your understanding. Discover systematic approaches to troubleshooting, backed by detailed case studies and practical solutions. Enhance your expertise and stay ahead in the competitive pharmaceutical landscape with our comprehensive guide to effective defect management.
Learning Objectives
- Understanding AQL in Pharmaceutical Manufacturing
- Definition and Importance of AQL (Acceptance Quality Limit)
- Discuss how AQL helps in determining the maximum number of defective units, beyond which a batch is rejected.
- AQL Standards and Guidelines
- Overview of relevant standards (e.g., ISO 2859-1) and guidelines (e.g., FDA, WHO) for AQL.
- How these standards are applied in the pharmaceutical context
- AQL Sampling Plans - Description of different AQL sampling plans (single, double, multiple).
- How to choose the right sampling plan for your production process. - Case study of implementing an AQL sampling plan in an OSDF manufacturing setting
- Visual Inspection Defects in Oral Solid Dosage Forms
- Common Visual Defects: Identification and categorization of common visual defects in tablets and capsules
- Real-cases examples and images to illustrate each defect type.
- Root Causes of Visual Defects. Detailed analysis of potential causes for each type of defect
- Troubleshooting Visual Inspection Defects
- Systematic Approach to Troubleshooting Importance of thorough documentation and root cause analysis (RCA).
- Case Studies and Practical Solutions in the common Visual defects types
Speakers
Copyright Disclaimer
This copyright notice applies to all proprietary pages, images, text, programs, and other material available throughout this Internet site (collectively, this “Publication”). All materials posted on the website are subject to copyrights owned by the International Society for Pharmaceutical Engineering (“ISPE”) and other individuals or entities. Any reproduction, retransmission or republication of all or part of any documents found on this site is expressly prohibited, unless ISPE or the copyright owner of the material has expressly granted its prior written consent to reproduce, retransmit or republish the material. All other rights reserved. View entire copyright policy.
& Click the bell for notifications.