Articles tagged with “gmp”

Learn what must be included in a pharma quality agreement. This guide covers key clauses, sponsor vs. CDMO responsibilities, and GMP regulatory requirements fro

Learn the fundamentals of pharmaceutical stability programs. This guide covers study design, execution, and data trending per ICH & FDA guidelines to set shelf

Understand analytical method validation with this deep dive into ICH Q2(R2). Explore validation parameters, documentation, and the new QbD lifecycle approach wi

Learn how Quality by Design (QbD) and IT systems are shifting pharma from end-product testing to real-time quality assurance with PAT and data analytics.

Learn the integrated workflow for manufacturing deviations, CAPA, and change control in GMP. This guide covers regulatory requirements and common inspection pit

An in-depth analysis of the build vs. buy decision for a quality management system (QMS) in biotech startups. Explore costs, timelines, and compliance factors.

Who owns pharmaceutical proofreading? This analysis explores the roles of artwork, regulatory, and QA teams in the pharma labeling workflow to prevent costly er

Get a 6-month checklist for pharmaceutical labeling operations. This guide covers key steps for regulatory approval, FDA/GMP compliance, and avoiding costly del

Is ISO 9001 still used in biotech? This guide analyzes how the QMS standard supports regulatory compliance, complements GMP, and improves quality in pharma & li

A comprehensive guide to lab equipment qualification (IQ/OQ/PQ). Learn the process, regulatory standards, and how automation streamlines validation and complian

An in-depth guide to the ICH Q10 model for Pharmaceutical Quality Systems (PQS). Explore its core elements, lifecycle approach, and integration with GMP regulat

An analysis of top ERP systems for the pharmaceutical sector, evaluated on regulatory compliance (21 CFR Part 11), batch traceability, and serialization.

Learn about regulatory compliance software in pharmaceuticals, covering GMP, GLP, GCP, FDA 21 CFR Part 11, and EU Annex 11 standards for data integrity.

Explore Good Manufacturing Practice (GMP) in pharma. Learn its principles, global regulations, implementation, and compliance challenges for quality assurance.

Comprehensive guide on implementing CAPA dashboards in pharmaceutical quality management, covering data requirements, key metrics, dashboard design principles, and implementation in Power BI, Tableau, and Google Data Studio.

Comprehensive overview of how computer vision technologies are revolutionizing pharmaceutical quality control processes, from tablet inspection to packaging verification, with real-world implementation examples and ROI analysis.