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FDA Warning Letter Analysis: Dabur India Limited

FDA Warning Letter analysis of Dabur India Limited covering CGMP violations, data integrity failures, import alert, recalls and remediation expectations....
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Featured image for a news article about the new PIC/S Qualification and Validation Guidance (PI 006-4), highlighting major updates to process validation, cleaning validation, equipment qualification, and quality risk management effective from August 2026.

PIC/S Issues PI 006-4 on Qualification and Validation, Effective 1 October 2026

PIC/S PI 006-4 introduces major updates to qualification and validation, including process validation, cleaning validation, qualification, data integrity, and quality...
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Featured image for a GMP Insiders news article on EMA's Q&A guidance for microbial contamination control in non-sterile medicinal products. The graphic shows regulatory documents clipped together, representing new EMA expectations for contamination control, cleaning validation, and quality risk management in pharmaceutical manufacturing.

EMA Issues Q&A Guidance on Technical and Organizational Controls for Microbial Contamination in Non-Sterile Medicinal Products

The European Medicines Agency has published a new Q&A clarifying GMP expectations for preventing microbial contamination in non-sterile medicinal products....
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Cleanroom equipment with text overlay showing comparison of qualification and validation in GMP.

Qualification vs Validation: Key Differences in GMP

Qualification vs. Validation explained for GMP professionals — clear regulatory differences, lifecycle expectations, and real-world applications across pharma systems....
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clean hold time vs dirty hold time studies in cleaning validation - featured image

Clean Hold Time (CHT) and Dirty Hold Time (DHT) Studies in Cleaning Validation

Explore the critical role of Clean Hold Time (CHT) and Dirty Hold Time (DHT) in cleaning validation. This in-depth guide...
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Risk-Based Contamination Control Strategy (CCS)

Learn how to build a risk-based Contamination Control Strategy (CCS) that meets Annex 1 (2022) expectations. Discover the key elements,...
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FDA Warning Letter Analysis: Chem-Tech, Ltd. – Deficiencies in OOS Investigation, Cleaning Validation and More

FDA issues a warning letter to Chem-Tech, Ltd. for improper OOS investigations, unvalidated cleaning procedures, and poor quality oversight. Key...
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FDA Issues Warning Letter to Strukmyer Medical Highlighting Serious CGMP Deficiencies

On January 30, 2025, the FDA issued a Warning Letter (320-25-37) to Strukmyer LLC dba Strukmyer Medical, following an inspection...

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Validation Master Plan (VMP) In the Pharmaceutical Industry

Validation Master Plan (VMP) In the Pharmaceutical Industry

Learn how to create a comprehensive Validation Master Plan (VMP) to ensure consistent product quality and regulatory compliance...
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Worst Case Selection in Cleaning Validation

Worst Case Selection in Cleaning Validation

Optimize cleaning validation in pharmaceutical manufacturing with key strategies for selecting worst-case scenarios, ensuring product safety and efficacy....
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