Category: Articles

The Articles category is the central knowledge base of GMP Insiders, offering guidance, analysis, and technical resources across all areas of pharmaceutical compliance. It spans the core foundations of GMP, including quality assurance, quality control, manufacturing, microbiology, distribution, computerized systems, and research and development.

Content is created to support professionals at every level — from daily operations to long-term strategy, by linking regulatory expectations with practical implementation. This section allows readers to explore a broad range of GMP topics in one place, navigate across specialized subcategories, and access resources that strengthen technical expertise and compliance.

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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....
Pre Use Post Sterilisation Integrity Testing (PUPSIT) According to Annex 1 - Featured Image

Pre-Use Post Sterilisation Integrity Testing (PUPSIT) in Annex 1

Explore Annex 1 PUPSIT requirements, causes of filter damage, and how proactive integrity testing strengthens sterility assurance in aseptic processing....
Bioburden testing in the pharmaceutical industry - featured image

Bioburden Testing in the Pharmaceutical Industry

Bioburden testing in pharmaceuticals: methods, validation, and regulatory expectations for microbial control and sterilization assurance....
types of hepa filters used in the pharmaceutical industry - featured image

Types of HEPA Filters Used in the Pharmaceutical Industry

Explore HEPA filter types used in pharmaceutical cleanrooms. Understand H13 vs H14, ULPA, gel-sealed filters, and Annex 1 testing requirements....
CSV in pharmaceutical manufacturing - featured image

Computer System Validation (CSV) in the Pharmaceutical Industry

Practical guide to CSV in pharma: lifecycle validation, Annex 11 updates, GAMP 5 methods, CSA approach, and real-world compliance practices....

Cleanroom Classification According to ISO 14644-1

ISO 14644-1 cleanroom classification explained: particle limits, GMP grade mapping, and key compliance insights for sterile pharma manufacturing....
Quality by design (QbD) in pharmaceutical development - Featured Image

Quality by Design (QbD) In Pharmaceutical Development

Learn how Quality by Design (QbD) ensures consistent pharmaceutical quality through process understanding, risk management, and regulatory alignment....
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....
IDMP Ontology what is it and how to use it in your organization - featured image

IDMP Ontology: What It Is and How It Can Be Used in Your Organization

IDMP Ontology explained: how it supports regulatory data, improves data governance, and prepares your pharma organization for SPOR and ISO...
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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