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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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Showing posts from August, 2021

Posts

APQR In Pharma (Annual Product Quality Review)

by Prashant Suresh Devmore August 14, 2021

APQR Pharma Tips

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Autoclave (Steam Sterilizer) | Detailed Review

by Prashant Suresh Devmore August 01, 2021

Aseptic Validation

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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

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...

Factory Acceptance Test of Rquipment (FAT)

Factory Acceptance Test The pharmaceutical manufacturing process is full of equipment. Multiple types of equipment are being utilized for production of medicines. It was a traditional approach to handmade medicines. But now in the last few decades, the traditional approach is getting diminished and getting replaced with the latest technologies. More on the latest technology runs in auto, hence the qualification of technology, system, software, equipment, machinery is an essential criterion.

Heat Exchanger In Pharmaceuticals

Heat Exchanger The water system is playing a crucial role in the pharmaceutical industry's development. Water for injection is one of the prerequisites of the sterile dosage form in the manufacturing industry. The heat exchanger is equipment that maintains the temperature of WFI in WFI system flow. There are multiple usages of the heat exchanger. The name itself tells that it exchanges the heat of the medium .

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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/