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Top 10 Steps for Qualifying a New GMP Facility

The qualification of a GMP facility is essential to ensure the high standards of pharmaceutical production and to guarantee product quality. In our latest article, you will learn the 10 most important steps for the successful qualification of a new
  • GMP, GxP, Validation and Qualification

4 Key OQ Mistakes in Pharma to Avoid

Operational Qualification (OQ) is crucial in pharmaceutical manufacturing for ensuring compliance and product quality. This article outlines common OQ mistakes—such as inadequate planning, misunderstanding scope, poor documentation, and neglecting verification—and offers strategies to enhance quality assurance and safeguard patient safety.
  • Equipment Qualification, Validation and Qualification
Young woman wearing lab coat operating equipment in workshop

Installation Qualification (IQ): Everything About Equipment Qualification

Discover the significance of Installation Qualification (IQ) in the pharmaceutical industry. This process ensures compliance, optimal equipment performance, and effective risk management, playing a pivotal role in the success of pharma organizations.
  • Equipment Qualification, Validation and Qualification
Two women wearing lab coats working at factory in food or pharma production

Cleaning Validation: 8 Steps for FDA Compliance Success

Cleaning validation is crucial for FDA compliance in pharmaceutical and food industries, ensuring equipment cleanliness to prevent contamination. It involves meticulous planning, execution, and documentation to verify effectiveness and consistency. Failure to comply can lead to compromised product quality, recalls,
  • Cleaning Validation, Validation and Qualification

IQ, OQ, PQ: Essential Steps for Equipment Qualification

Equipment quality in pharmaceutical manufacturing is ensured through IQ, OQ, and PQ phases, validating installation, performance, and user needs. Regulatory mandates prevent hazards, like mislabeling, with ongoing compliance via requalification. Expert guidance streamlines validation efforts for robust, compliant systems.
  • Equipment Qualification, Validation and Qualification