GMP Design Review – A Comprehensive Guide to Ensuring Compliance from Concept to Completion

REPHINE SPEECH MARKS OPEN GXPCONSULTANCY

An early-stage design review ensures your facility meets GMP standards, minimises risks of cross-contamination, and optimises efficiency—setting your project up for success from the start.

REPHINE SPEECH MARKS CLOSE GXPCONSULTANCY

About this Guide

Conducting a design review in GMP-regulated environments requires careful planning, risk management, and a focus on compliance from the earliest stages.

Managing complex product types, contamination risks, and process variations demands a proactive approach and thorough evaluation.

In this comprehensive guide, we outline key strategies for conducting effective Conceptual and Basic Design Reviews. Discover how to assess material flows, optimise equipment layouts, and ensure your facility design meets GMP requirements—minimising risks and avoiding costly modifications.

For an in-depth look at how early design reviews can set your project up for success, download the guide now.

Hero Image GMP Design Review Guide

View our other resources and company news

GMP Raising the bar Blog series Header image May 25 Blog

Building Resilient Pharmaceutical Supplier Ecosystems

In today's volatile landscape, traditional supplier qualification is no longer enough. Learn how pharma companies can build resilient supplier ecosystems through risk-based strategies, real-time monitoring, ...
Read More
CPV Header image blog apr 25 Blog

IT Quality Assurance in Pharma: Ensuring Compliance, Validation & Data Integrity

IT Quality Assurance plays a pivotal role in the life sciences sector, ensuring systems are validated, compliant, and audit-ready. Learn how pharma companies can meet ...
Read More
GMP Raising the bar Blog series Header image May 25 Blog

IT Quality Assurance in Pharma: Ensuring Compliance, Validation & Data Integrity

Artificial intelligence and data analytics are reshaping pharmaceutical GMP compliance—but not all innovations are audit-ready. This article explores proven AI use cases, regulator expectations, and ...
Read More
GMP Raising the bar Blog series Header image May 25 Blog

Risk-Based Auditing: Smarter GxP Compliance with Limited Resources

In today’s pharma landscape, risk-based auditing enables smarter supplier oversight by aligning audit efforts with risk. Discover the benefits, regulatory backing, and how Rephine helps ...
Read More
Pharma equipment qualification hero image Case Study

Pharmaceutical Equipment Requalification Case Study

See how Rephine helped a global pharma company streamline equipment requalification across complex sites with a scalable, risk-based approach aligned with Annex 15.
Read More
GMP Raising the bar Blog series Header image May 25 Blog

Continuous Inspection Readiness Beyond Mock Audits

Traditional mock audits aren’t enough. With rising unannounced inspections, pharmaceutical and biotech firms must embrace continuous inspection readiness. This article explores how to embed compliance ...
Read More
GMP Raising the bar Blog series Header image May 25 Blog

How Rephine Accelerates Digital QMS Transformation in Pharma

Rephine helps pharmaceutical and biotech companies transition to digital QMS platforms like Veeva Vault, MasterControl, or TrackWise. From vendor-neutral selection to full GxP-compliant validation and ...
Read More
CPV Header image blog apr 25 Blog

Threat Modelling in Medical Devices: STRIDE for MDR/IVDR Cybersecurity Compliance

Understand how STRIDE and other threat modelling techniques help medical device manufacturers meet MDR/IVDR cybersecurity requirements—plus real-world examples and expert insights.
Read More
Medical Device Guide

Security Risk Management for Medical Devices: MDR & IVDR Compliance Whitepaper

Understand how to embed cybersecurity into the medical device lifecycle with this expert guide from Rephine. Includes MDR/IVDR, FDA, and IMDRF guidance on SRM, threat ...
Read More
Contact Us