Industry 4.0 for Pharmaceutical Manufacturing Guide
GUIDE: Industry 4.0 Industry 4.0 for Pharmaceutical Manufacturing: A GMP-Compliant Implementation Guide Industry 4.0 technologies (Internet of Things sensors, artificial intelligence, digital twins, cloud-based batch records, and automated pr
Equipment Qualification Failure: A GMP Case Study
SITUATIONAL: Equipment Qualification When Equipment Qualification Is Skipped: A Pharmaceutical Facility's Costly Lesson Equipment qualification programmes exist to confirm that manufacturing and laboratory equipment performs as intended withi
ICH Q7 Materials Management: Worker Safety Guide
WORKER SAFETY: ICH Q7 GMP ICH Q7 Resources and Materials Management: What Pharmaceutical Workers Need to Know If you work in an API manufacturing facility, you handle materials that go into medicines taken by real patients. ICH Q7 sets the ru
10 ICH Q7 Quality Management Tips for API Compliance
TIPS: ICH Q7 GMP Compliance 10 Practical Tips for Implementing ICH Q7 Introduction and Quality Management Requirements ICH Q7 establishes GMP requirements for active pharmaceutical ingredient manufacturing. Its opening chapters on quality man
Drug Retention and Stability Testing: Compliance
SITUATIONAL: Drug Retention and Stability Testing How to Meet Drug Retention and Stability Testing Requirements: Lessons from a Compliance Failure Pharmaceutical manufacturers and contract laboratories are required to maintain retain samples