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PD Pharma Insights

Expert insights into Quality Management Systems (QMS), Quality Risk Management (QRM), and Sterile Validation. Managed by Prashant Devmore (M.Pharm), an Associate Manager with 11+ years of experience at Zydus, Cipla, and Indoco. Specializing in Computer System Validation (CSV), 21 CFR Part 11 compliance, and USFDA/MHRA audit readiness.

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The Master Guide to Quality Risk Management (QRM) in Sterile Manufacturing: An ICH Q9 Perspective

by Prashant Suresh Devmore January 15, 2026

Quality Risk Management

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The Definitive Guide to Air Flow Pattern Studies in Aseptic Processing: A Quality & Validation Perspective

by Prashant Suresh Devmore January 12, 2026

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Navigating Computer System Validation (CSV): Ensuring Data Integrity in Aseptic Processing

by Prashant Suresh Devmore January 11, 2026

Computer system validation

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🧪 Top 5 Must-Have Lab Equipment for Pharma Professionals – Buy Online in India

by Prashant Suresh Devmore October 04, 2025

Pharma equipment

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Explained: Bioavailability and Bioequivalence – A Comprehensive Guide

by Prashant Suresh Devmore October 03, 2025

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Insulin Resistance: Mechanism, Risks, and Strategies for Reversal

by Prashant Suresh Devmore September 30, 2025

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Understanding Metformin: Mechanism of Action, Clinical Uses, and Safety Profile

by Prashant Suresh Devmore September 24, 2025

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OOS Investigation Tools: Streamlining Out-of-Specification Investigations

by Prashant Suresh Devmore December 30, 2024

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Expertise Areas

AI In Healthcare ›
Aseptic Validation ›
Computer System Validation ›
Drug Reviews ›
Quality Risk Management ›
Quality Management System (QMS) ›

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The Master Guide to Quality Risk Management (QRM) in Sterile Manufacturing: An ICH Q9 Perspective

1. Introduction: From Reactive to Proactive Quality In the high-stakes environment of sterile injectables, waiting for a failure to occur is not an option. Quality Risk Management (QRM) is the systematic, proactive process of assessing, controlling, communicating, and reviewing risks to product quality. Drawing from my 11+ years of experience navigating USFDA and MHRA audits. I have seen that a robust, scientifically sound QRM program is the fundamental difference between a minor observation and a severe Warning Letter. 2. The Regulatory Bedrock: Understanding ICH Q9(R1) The International Council for Harmonisation (ICH) provides the global standard through the Q9 guideline. The recent revision, ICH Q9(R1) , emphasizes reducing subjectivity and ensuring a scientific basis for risk assessments. Patient Protection: The core purpose of QRM is to safeguard the patient; all evaluations must link back to patient health. Proportionality: The level of effort and doc...

Aseptic manufacturing and terminal sterilization difference - Basics of aseptic processing

Aseptic manufacturing and terminal sterilization difference - Basics of aseptic processing This post is related to pharmaceutical sterile drug manufacturers. So many sterile dosage forms are there and all of them are either terminally sterilized or aseptically manufactured. There is a huge difference between aseptic manufacturing and terminal sterilizatio n . Both these are the sterile process.

How do pharmaceutical companies work?

How do pharmaceutical companies/industries work? Everybody knows medicines are prepared by Pharmaceutical companies. Medicines are to diagnose , treat, prevent, cure, and mitigation of diseases . The pharmaceutical industry or company is nothing but a place where research and development of drugs and manufacturing of medication are done. Pharmaceuticals are developed more and more precisely as centuries passed on. Every moment there are so many newly discovered methods, drugs, and medicines that are coming to the market.

Prashant Devmore

Prashant Devmore

M. Pharm | 11+ Years QA Expert

Founder of PD Pharma Insights. Leveraging a decade of leadership at Cipla, Indoco, and Zydus to bridge technical excellence and regulatory compliance in Biopharmaceutics.

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Empowering Pharma Professionals Since 2024

Prashant Devmore

Associate Manager | QA & Validation
M.Pharm | 11+ Years Experience

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Prashant Devmore https://pdtechreviews.blogspot.com/