Ensuring Regulatory Compliance for Market Approval

As drug products move toward commercialization, Process Performance Qualification (PPQ) and validation batches are essential for obtaining regulatory approval and ensuring readiness for the market. At MedPharm, we manufacture registration batches in GMP-certified facilities, ensuring that your drug product meets the highest standards of regulatory compliance, quality, and safety required for FDA, EMA, and ICH submissions.   

Our PPQ and validation batch programs help mitigate risks associated with commercial manufacturing by ensuring consistent, reproducible, and scalable production processes that meet critical quality attributes (CQAs) and regulatory expectations.   

Comprehensive Registration Batch Manufacturing Services

Process Performance Qualification (PPQ) Batches  

PPQ batches confirm that your manufacturing process consistently produces high-quality drug products that meet regulatory expectations.  

• GMP-compliant production of PPQ batches for NDA, BLA, ANDA, and MAA filings  

• Verification of process reproducibility across multiple commercial-scale batches  

• Alignment with FDA, EMA, and ICH process validation requirements  

• Comprehensive batch record documentation for regulatory filings 

Validation Batches for Commercial Launch  

Validation batches demonstrate that your commercial-scale production process meets predetermined quality criteria, ensuring consistent batch-to-batch reproducibility.  

• Validation of critical process parameters (CPPs) and critical quality attributes (CQAs)  

• ICH-compliant stability testing to confirm shelf-life and formulation integrity  

• Analytical method validation and real-time process monitoring  

• Full regulatory documentation support for marketing approval 

Regulatory & Quality Oversight  

MedPharm’s regulatory and quality teams work closely with clients to ensure that registration batches comply with:  

• FDA & EMA Guidelines for Process Validation  

• ICH Q8, Q9, and Q10 requirements for pharmaceutical development  

• cGMP requirements for commercial production  

• Global regulatory submission standards for NDA, BLA, ANDA, and MAA    

Seamless Transition from PPQ to Commercial Manufacturing  

Once PPQ and validation batches are successfully completed, MedPharm ensures a smooth transition to full-scale commercial manufacturing, providing:  

• Ongoing process monitoring and quality control  

• Batch-to-batch reproducibility and efficiency optimization  

• Scalability for global commercial supply 

Ensure Regulatory Success with MedPharm’s PPQ & Validation Batch Expertise

With decades of experience in clinical and commercial manufacturing, MedPharm ensures that your registration batches meet the highest standards for regulatory compliance, quality, and safety, helping you achieve market approval and commercial success.