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Category: QA

The Quality Assurance (QA) category focuses on the systems and processes that form the foundation of GMP compliance. QA ensures that products are manufactured, tested, and released under controlled conditions that meet regulatory standards.

Key topics include pharmaceutical quality systems (PQS), documentation, deviation and CAPA management, change control, supplier qualification, product quality reviews (PQR), and inspection readiness. Risk-based approaches, data integrity, and integration with Quality Control (QC) are also highlighted.

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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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ALCOA++ in GMP: Practical Data Integrity for Labs and Manufacturing - Featured Image

ALCOA++ in GMP: Practical Data Integrity for Labs and Manufacturing

Explore ALCOA++ in GMP: practical data integrity principles that keep records accurate, traceable, and inspection-ready....
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Supplier Qualification in GMP – What Do You Need to Consider?

Improve supplier qualification management through practical GMP steps, detailed checklists, audits, and ongoing performance monitoring....
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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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GMP vs cGMP: What is the Difference?

GMP vs cGMP—understand what “current” means for today’s quality standards, compliance expectations, and pharma manufacturing practices...
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FDA Inspection Readiness Guideline: How to prepare for unannounced global audits

FDA Inspection Readiness: How to Prepare for Unannounced Global Audits

Discover global strategies for FDA Inspection Readiness, real-time GMP compliance, and regulatory confidence....
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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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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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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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6 Steps on How to Perform Root Cause Analysis (RCA)

6 Steps on How to Perform Root Cause Analysis (RCA)

Learn the 6 key steps to perform Root Cause Analysis (RCA) in pharmaceutical GMP. Prevent recurrence, improve compliance, and enhance...
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