Our Peer Reviewed Industry Journal Articles:

• Latreille, P., Pazhayattil, A., Turner, S., Talwar, N. (2024). A Novel Image Processing Technique for Weighted Particle Size Distribution Assessment, Drug Development and Industrial Pharmacy

• Pazhayattil, A., Jennings, S., Spengler, C. (2024). Cell Culture Media Manufacturing Controls for Bio-Manufacturing, ISPE

• Elsaid, A., Pazhayattil, A. (2024). Legacy Filling Lines Evolve: Safeguarding with RABS Technology, PDA

• Pazhayattil, A., Sagar, P., Joseph, P. (2023). Time to Start Using Polypropylene Vials in the Industry, PDA

• Sagar, P., Pazhayattil, A. (2023). Polypropylene (PP) Vials: An Efficient Primary Packaging Solution for Injectables, AAPS

• Elsaid, A., Pazhayattil, A. (2022). A Successful Q-Model for New mRNA Line Commissioning & Qualification, PDA

• Pazhayattil, A., Kotini, K., Kodidela, M., Scribner, M. (2022). Accelerating Biopharmaceutical Virtual FATs in a Pandemic, ISPE

• Pazhayattil, A. (2022). Biopharma Equipment Design, Qualification and Monitoring Model, Institute of Validation Technology Journal

• Pazhayattil, A. (2022). Machine Learning and Artificial Intelligence Strategies for the Pharmaceutical Industry, ProQuest Dissertations & Theses
• Pazhayattil, A. (2021). Quality Management Systems for Drugs and Devices, RAPS

• Pazhayattil, P., Galande, A., Badabhagni, S.R. (2021). Effect of Gum on In-vitro Dissolution of Oral Suspensions, ISPE

• Pazhayattil, A. (2021). Prognosis of Legacy PfOS Process through Stage 3a Monitoring, Institute of Validation Technology Journal

• Tomassini, S., Pazhayattil, A.,  Ingram, M. (2020). A Novel Dev. and Portfolio Mgmt. Strategy for Generic Small Mol., Journal of Generic Medicine
• Pazhayattil, A., Sayeed, N., Chen, S., Ingram, M. (2020). A Semi-Quantitative Risk Assessment Methodology Fit for Lifecycle, PDA Journal
• Pazhayattil, A. (2020). Continued Process Verification: Reacting to Data Signals, PDA

• Pazhayattil, A., Ingram, M., Sayeed, N. (2019). A Quantitative Study of US FDA Inspection Data for Drug Manufacturing Sites, DIA Journal

• Sayeed, N., Pazhayattil, A., Louis, I (2018). Prospects for Post-Approval Change Management, PDA

• Pazhayattil, A., Sayeed, N. (2017). Excipient Usage Technical Risk Assessment, IPEC Journal

• Ingram, M., Pazhayattil, A, Sayeed, N., Desai, G. (2017). Manufacturing Excellence Utilizing a Life Cycle Approach, ISPE 

• Sayeed, N., Pazhayattil, A., Collins, J., Doshi, C. (2018). A Science and Risk-Based Methodology for BU, CU Assessment, AAPS PharmSciTech
• Pazhayattil, Sayeed, N., Iyer, V. (2017). ICH Q12 Post Approval Change Management Protocol: Advantages, RAPS
• Pazhayattil, A., Ingram, M., Sayeed, N. (2019). Modernizing Pharmaceutical Manufacturing, AAPS
• Pazhayattil, A. (2017). How Global Orgs Can Achieve Process Validation Success, PDA
• Sayeed, N., Pazhayattil, A., Collins, J., Chen, S., Ingram, M., Spes, J. (2016). Assessment Methodology for Process Validation Lifecycle Stage 3a, AAPS PharmSciTech
• Pazhayattil, A., Alsmeyer, D., Chen, S., Hye, M., Ingram, M., Sanghvi, P. (2015). A Scientific Approach to Determine the Number of PPQ Batches, AAPS PharmSciTech
• Alsmeyer, D., Pazhayattil, A., Chen, S., Munaretto, F., Hye, M., Sanghvi, P. (2015). Acceptance Probability (Pa) Analysis for PV Lifecycle Stages, AAPS PharmSciTech

Other Articles:

• Pazhayattil, A. (2025). Clinical Formulation and Manufacturing: A Strategic Leap for Indian Bulk Drug Manufacturers, Bulk Drug Manufacturers Association 
• Ingram, M., Pazhayattil, A., Sagar, P., Chakraborty, S. (2025). 2024 Trends In FDA Observations For Sterile Drug Manufacturers, Outsourced Pharma
• Pazhayattil, A. (2025). Fortifying API Supply Chains 2025 and Beyond, Bulk Drug Manufacturers Association
• Pazhayattil, A. (2024). Indian Pharma Industry: Urgent Need for Action in the Manufacturing Sector, Express Pharma
• Pazhayattil, A., Ingram, M. (2024). Stage 3a: A Key Indicator For Process Validation Maturity, Biosimilar Development
• Pazhayattil, A. (2024). A New Year Call for Action: Analysing 2023 FDA Form 483 Observations for Indian Sterile Manufacturing Facilities, Express Pharma
• Pazhayattil, A., Joshi, S., Ingram, M. (2024). 2023–2024 Trends in FDA 483s For Pharmaceutical Formulation Facilities, Outsourced Pharma
• Pazhayattil, A. (2024). Advancing ML and AI in Pharmaceutical Manufacturing, Pharma Focus 
• Joshi, S., Pazhayattil, A., Ingram, M. (2024). Critical Behavioral Attributes and Application of COM-B in Aseptic Processing, American Pharmaceutical Review
• Pazhayattil, A., Ingram, M. (2024). Safeguarding Sterility: Crucial Insights from 2023 Facility Audits, Pharma Focus Europe
• Pazhayattil, A., Gischewski, M., Pathan, S. (2024). Outsourcing And Phase-Appropriate GMP For Clinical Needs, Clinical Supply Leader
• Pazhayattil, A., Konyu-Fogel, G. (2023). ML and AI Implementation Insights for Bio/Pharma Manufacturing. BioPharm International
• Spes, J., Pazhayattil, A. (2023). Embracing AI-Driven Technology In Drug Development, Manufacturing, Outsourced Pharma
• Pazhayattil, A., Ingram, M. (2023). Key Post-Pandemic Trends in FDA Observations For Drug Facilities, Life Science Leader
• Turner, S., Talwar, N., Pazhayattil, A. (2022). Novel Formulations and Line Extensions with Soft Capsule Technology, PharmTech
• Joseph, P., Pazhayattil, A. (2022). Taking a QbD Approach to Packaging Development, Pharmaceutical Manufacturing
• Pazhayattil, A. (2022). Risky Business: Managing Risk In Biopharma Manufacturing, BioProcess
• Pazhayattil, A. (2022). A Better Path for CMO Relationships, Lifescience Leader
• Pazhayattil, A., Joseph, P., Forsythe, C. (2022). FAT, SAT & Commissioning Activities, Oh My!, Life Science Connect
• Venugopalan, P., Pazhayattil, P., Ingram, M. (2021). Update On Regulatory Strategies To Mitigate Mutagenic Impurities, Life Science Connect
• Pazhayattil, A., Sharma, S., Galande, A., Ingram, M., Rhoades, R. (2021). Assessing Manufacturing Process Robustness, BioPharm International
• Pazhayattil, A., Sharma, S., Galande, A., Ingram, M., Rhoades, R. (2021). Assessing Legacy Drug Quality, PharmTech.
• Galande, A., Pazhayattil, A., Sharma, S. (2021). A Checklist For Risk Assessment of Nitrosamine Impurities, Life Science Connect
• Pazhayattil, A. (2020). Solving Pharma’s Quality Unit Identity Crisis, PharmTech
• Pazhayattil, A. Ingram, M., Duyan, E., Zurita, V. (2020). Getting to the Root of Quality Problems, BioPharm International
• Pazhayattil, A, Ingram, M., McFarland, A.B., Sayeed, N. (2019). A Roadmap for QRM Principles in DS Manufacturing, American Pharmaceutical Review
• Pazhayattil, A, Ingram, M., Sayeed, N. (2019). Lessons from FDA 483s and cGMP Inspection Data, PharmTech
• Pazhayattil, A, Ingram, M., Kumar, R., Rao, S., Meier, R. (2019). Is Continuous Manufacturing A Good Fit For Generic Products?, Life Science Connect
• Sayeed, N., Pazhayattil, A., Ingram, M. (2019). ICH Q12: Bringing Regulatory Flexibility to Post-Approval Changes, BioProcess
• Pazhayattil, A, Mathew, A., Ingram, M., Sayeed, N. (2018). Risk Mitigation Strategies for Compounding Pharmacies, Life Science Connect
• Sayeed, N., Pazhayattil, A., Ingram, M. (2018). Lifecycle-Based PV Emphasizes the Need for CPV, PharmTech
• Pazhayattil, A, Ingram, M., Sayeed, N. (2018). Cross-Sector Intelligence: The Prospects for Data Convergence, LifeScience Connect
• Pazhayattil, A, Ingram, M., Sayeed, N. (2018). The Impact Of Regulatory & Analytics Evolution, Life Science Connect
• Pazhayattil, A. (2017). PAT from a Small Molecules Vantage Point, BioPharma International
• Pazhayattil, A., Sayeed, N. (2017). A Semi-Continuous Operations Model for Solid-Dose Manufacturing, Life Science Connect
• Collins, J., Sayeed, N., Pazhayattil, A., Doshi, C. (2017). A Continuous Improvement Metric for Pharmaceutical Manufacturing, PharmTech
• Pazhayattil, A., Sayeed, N., Collins, J., Doshi, C. (2017). A Novel Metric for Continuous Improvement during Stage Three, BioPharma International
• Pazhayattil, Spes, J., Chaudhary, R.S. (2017). Continuous Manufacturing: A Generic Industry Perspective, PharmTech
• Sayeed, N., Pazhayattil, A., Spes, J (2017). Quality Metrics and CMO Agreement: Significance of FDA Guidance, PharmTech
• Sayeed, N., Chowdari, S., Pazhayattil, A. (2016). Determining Minimum Batch Size, PharmTech​
• Alsmeyer, D., Pazhayattil, A. (2014). A Case for Stage 3 Continued Process Verification, Pharmaceutical Manufacturing
• Pazhayattil, A. (2012). How to Conduct an Effective APQR, Pharmaceutical Manufacturing
• Pazhayattil, A. (2012). GMP Compliance? There's An App for That!, Pharmaceutical Manufacturing
• Pazhayattil, A. (2008). Quality Agreements: Making Them Stick, Pharmaceutical Manufacturing

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