Line Clearance & In-Process Control: Best Practices (Webinar)

What Will You Learn?

• Part 1: Line Clearance
• Definition & Concept
• What line clearance means in pharmaceutical production.
• Regulatory & Quality Requirements
• What GMP, WHO, and ISO guidelines say about line clearance.
• Reference to specific clauses or expectations (ISO, WHO TRS, PIC/S).
• Why Line Clearance is Mandatory
• Role in preventing cross-contamination and mix-ups.
• Impact on product quality and compliance.
• Responsibility & Authorization
• Who performs and who authorizes line clearance (Production vs QA).
• Training & Competency
• How to effectively train staff on LC procedures.
• Demonstration-based and checklist-based training methods.
• Assessment & Evaluation
• How to verify that clearance was properly executed.
• Documentation review and QA verification.
• Qualification Process
• Qualification/validation of cleaning and clearance processes.
• Routine vs periodic qualification.
• Part 2: In-Process Control (IPC)
• Definition & Purpose
• What IPC means and its critical role in process assurance.
• Need for In-Process Control
• Ensuring batch uniformity, yield consistency, and early defect detection.
• Responsibility
• Who performs IPC and documentation responsibilities (Production vs QC).
• Common Challenges for Production Pharmacists
• Practical issues: time pressure, sampling errors, inconsistent data recording.
• How to overcome them with simple process improvements.
• Integration Between IPC and Line Clearance
• How both work together for compliance and efficiency.
• Real examples from solid dosage manufacturing