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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 2026 Guide to Pharmaceutical Validation: How to Save 40% Time Using Digital QA Tools & CSA Frameworks

by Prashant Suresh Devmore March 03, 2026

Digital Transformation

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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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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

Expertise Areas

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

Most Popular Industry Insights

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.

OOS In Pharma: OOS Investigation, Laboratory Investigation, Detailed Review

OOS In Pharma | OOS | Laboratory Investigation | Detailed Review Author: Mrs. Bhagyashree Prashant Devmore ------------------------------------------------------ Out-of-specification ( OOS) in the Pharma industry is one type of investigational tool used for laboratory investigations. Nowadays, the OOS is the first choice that is being inspected by regulatory inspectors during laboratory audits. More often OOS investigations are required in the pharmaceutical industry to identify the potential contributing factors that are affecting the quality of the product. So, in this post, we will cover the following, 1. What is OOS in pharma? 2. What are the basic concepts of the OOS? 3. How to investigate OOS?

Stability Study | New Drug Substances, Products | ICH Q1A (R2)

Stability Study of New Drug Substances and Products ICH Q1A (R2) This post gives us an idea about data that is to be submitted in registration applications for new molecular entities and associated drug products. We are going to see guidelines regarding the stability study of new drug substances and products (ICH Q1A) R2.

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Prashant Devmore

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

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