Change Control in Pharmaceuticals | Complete GMP Process, Impact Assessment & Documentation Explain

Change Control in the Pharmaceutical Industry

This video provides a complete and professional explanation of the Change Control System used in GMP-regulated pharmaceutical manufacturing.
It covers purpose, documentation, workflow, impact assessment, regulatory requirements, and real industry examples.

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🔍 What You Will Learn

What is Change Control?

Regulatory expectations (GMP, ICH, WHO)

Types of Change Control (Major, Minor, Temporary, Permanent)

Change initiation and approval flow

Impact assessment on Quality, Validation, Safety, Equipment & Regulatory

Link with Deviation, CAPA, and Process Validation

Documentation requirements and lifecycle

Practical real-world examples



🎥 Watch the Complete Change Control Video:

👉    • Change Control in Pharmaceuticals | Comple...  

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🔗 Highly Recommended Supporting Videos

1️⃣ Quality Risk Management (QRM)

   • Quality Risk Management (QRM) in Pharma In...  

2️⃣ Cleaning Validation

Demonstration of Cleaning Validation
   • Cleaning Validation Demonstration | Step-b...  

How to calculate MACO (Maximum Allowable Carryover)
   • How to calculate MACO for Cleaning Validat...  

3️⃣ Process Validation

Blend Uniformity (Process Validation Step)
   • Process Validation in 2025 Overview for ph...  

Stratified Sampling (Compression Stage)
   • Fully Automatic @Cleaning Validation  


4️⃣ Analytical Method Validation (AMV)

(Add your AMV video link here when available)


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⭐ Optional but Relevant (as per GMP / QMS Integration)


Hold Time Study in Pharma (Affects Change Control Decisions)

   • What is worst case in cleaning validation?  

CPP, CQA, CMA, QTPP & QbD Explained (Helps in impact assessment)

   • Process Validation | CPP | CQA | QTPP | Qb...  


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