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

Medical Software as MD MedTech Guide Header Image (1500 x 844 px) Guide

When Does Medical Software Qualify as a Medical Device? | MDR & IVDR Guide

Learn when medical software qualifies as a medical device under EU MDR & IVDR regulations. Explore classification rules, examples, and compliance tips for manufacturers.
Read More
Dmf case study header Case Study

Navigating DMF Registration in China with Rephine

Explore case study showing the development of a project for a new pharmaceutical manufacturing plant with the objective to fulfill GMP requirements and minimise risks ...
Read More
DMF blog image mar 25 Blog

Breaking into the Chinese Pharmaceutical Market: How to Successfully File a DMF

Learn how to navigate DMF submission in China with Rephine’s expert guidance. From compliance reviews to NMPA approval — streamline your entry into the Chinese ...
Read More
ICH E6 Guide Header Image (1500 x 844 px) CSV

Understanding ICH E6 (R3): Good Clinical Practice and Computerised Systems Validation

The Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation (AIQSV) is an essential resource for pharmaceutical laboratories striving to meet ...
Read More
Intended Purpose MedTech Guide Header Image (1500 x 844 px) Guide

Understanding Intended Purpose in EU MDR & IVDR: Key Implications for Medical Device Manufacturers

Our guide simplifies GSPR compliance, helping medical device companies meet EU safety standards, streamline CE marking, and get market-ready faster.
Read More
qms background Guide

Why eQMS is Important? The Critical Role of eQMS in Modern Quality Management

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end
Read More
UKCA Marking Header image Guide

Understanding the UKCA Certification for Medical Devices

Navigating UKCA certification is essential for manufacturers seeking access to the Great Britain market. Understanding the regulatory landscape, transitional provisions, and compliance steps is key ...
Read More
Key Deadlines Header image Ebook

Key Deadlines for Medical Device Manufacturers under MDR and IVDR

Discover everything you need to know about MDR and IVDR compliance timelines for 2025. This eBook provides actionable insights to help manufacturers stay compliant and ...
Read More
rems audits Guide

REMS Program Audits: Ensuring Safety and Compliance

Navigating the FDA’s Risk Evaluation and Mitigation Strategy (REMS) requirements can be challenging, but it is critical for ensuring medication safety and regulatory compliance.
Read More
Contact Us