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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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Complaint management and investigation in GMP focusing on risk-based governance, escalation, CAPA linkage, and compliance oversight.

Complaints Management in the Pharmaceutical Industry

Practice-oriented guide to pharmaceutical complaint management: definitions, risk-based triage, investigations, CAPA, recall interfaces, and trending KPIs....
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Good Documentation Practice (GDocP) in GMP, highlighting the role of structured, controlled documentation in ensuring data integrity, regulatory compliance, and trustworthy pharmaceutical records.

Good Documentation Practice (GDocP) in Pharma

A practical guide to Good Documentation Practice (GDocP) in pharma, covering ALCOA++, data integrity, inspections, electronic records, and compliance controls....
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Featured image for change control in the pharmaceutical industry, highlighting risk-based change classification, workflow, and regulatory expectations.

Change Control in Pharmaceutical Industry

Learn how GMP change control in pharma manages modifications through risk assessment, approval, and documentation to maintain regulatory compliance....
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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 management in GMP regulated industry - featured image

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 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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What is the difference between gmp and cgmp - featured image

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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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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