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How to write a gmp compliant user requirement specification in pharma - featured image

How to Write a GMP-Compliant User Requirement Specification (URS)

Learn how to write a GMP-compliant User Requirement Specification (URS) with regulatory guidance, risk-based principles, and its role in the...
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GMP Cleanroom

GMP Cleanroom Classifications: Grade A, B, C and D

Explore GMP cleanroom classifications A to D, ISO equivalents, particle & microbial limits, and key qualification steps for contamination control....
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Cold Chain Management in the Pharmaceutical Industry

Cold Chain Management in the Pharmaceutical Industry

Discover the essentials of cold chain management in pharma to ensure the safety and efficacy of temperature-sensitive products like vaccines...
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Airflow Visualization Smoke Studies (AVS) in Cleanrooms

Airflow Visualization Smoke Studies (AVS) in Cleanrooms

Airflow Visualization Smoke Studies (AVS) ensure cleanroom compliance by visualizing airflow patterns to detect turbulence and verify unidirectional flow, critical...
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Supplier Qualification in GMP

Supplier Qualification in GMP – What Do You Need to Consider?

Learn the essential steps for supplier qualification, ensuring that suppliers meet GMP standards, mitigates risks, and maintains quality in the...
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The role of Batch Manufacturing Records - BMR in GMP

The Role of Batch Manufacturing Records (BMR) in GMP

Learn more about Batch Manufacturing Records (BMR), essential for consistent, safe pharmaceutical production and compliance with regulatory standards....
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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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Temperature Mapping in GxP Environment

Temperature Mapping in GxP Environment

Explore essential strategies for mitigating risks in temperature-controlled environments, ensuring product stability and safety in pharmaceutical storage....
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Pharmacovigilance

Pharmacovigilance – Ensuring the Safety of Medications

Explore the crucial role of pharmacovigilance in ensuring medication safety, from detecting adverse effects to proactive risk management....
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Design Review and Design Qualification in the Pharmaceutical Industry

Design Review and Design Qualification in the Pharmaceutical Industry

Explore the crucial roles of Design Review and Design Qualification in the pharmaceutical industry, ensuring equipment meets user needs and...
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Environmental Monitoring

Best Environmental Monitoring Practices for Pharma Industry

Explore best practices in environmental monitoring for pharmaceutical cleanrooms, ensuring sterility and safety with comprehensive guidelines and tips....
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Quality Risk Management Process

Quality Risk Management in the Pharmaceutical Industry

Explore the essentials of Quality Risk Management in Pharma: Principles, tools, guidelines, and implementation strategies for enhanced safety....
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Person working in QC Lab - LC

Impurities in Pharmaceuticals: Types, Regulations and Strategies

Discover the essential information about impurities in pharmaceuticals, their types, and how they impact drug quality. Learn about regulatory requirements,...
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Good Documentation Practice - FI

Good Documentation Practices in the Pharmaceutical Industry

Explore effective strategies for maintaining clear and comprehensive records with our guide on good documentation practices, ensuring accuracy and reliability....
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Electronic Quality Management System eQMS

Electronic Quality Management Systems – eQMS

Optimize compliance and quality control in the pharmaceutical industry with eQMS (Electronic Quality Management System). Streamline documentation, enhance regulatory adherence,...
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GxP - Person working in laboratory

Understanding GxP Regulations in The Pharmaceutical Industry

Navigate success in the pharmaceutical industry with GxP compliance. Explore GMP, GLP, GDP, and GCP for quality, safety, and regulatory...
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Revised EDQM Guideline on how to read a CEP

EDQM Publishes Revised Guideline on How to Read a CEP

Revised EDQM guideline explains how to read a CEP, covering CEP 2.0, site details, impurities, and regulatory declarations for better...
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Contamination Control Strategy Featured Image

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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deviation management process featured image

Deviation Management Process in GMP

Explore the full lifecycle of GMP deviation management—from detection and investigation to CAPA and trending for regulatory compliance and quality...
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USP-NF PROPOSED DRAFTS IN PF 51(3)

USP–NF PF 51(3) Draft Published

USP–NF PF 51(3) draft introduces new PAT, content uniformity, parenteral leachables, and CBD standards, enhancing GMP control and regulatory alignment....
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usp-233 elemental impurities procedures adopt the harmonized standard

Harmonized Standard for USP <233> Elemental Impurities—Procedures Adopted

Discover the 2025 USP update on elemental impurities: key changes, harmonization across pharmacopeias, and compliance insights....
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rabs-vs-isolators-fi

RABS vs Isolators: Which Barrier System Meets Annex 1 Expectations?

RABS vs Isolators: Key differences, Annex 1 expectations, and how to choose the right barrier system for your aseptic manufacturing...
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Method validation vs method verification: Key Differences

Difference Between Validation and Verification of Analytical Methods

Learn the key differences between method validation and verification in pharma labs, with clear guidance on when each applies and...
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ich q1 stability testing draft released

ICH Q1 Draft Guideline Released for Comment: Consolidated Stability Framework Moves Forward

ICH Q1 draft released: a unified guideline for stability testing with new content on lifecycle, in-use studies, modelling, and advanced...
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