In the pharmaceutical manufacturing industry, commissioning, qualification, and validation are three processes that are critical to ensuring that equipment, facilities, and systems make safe and effective medicines.

However, it can be most challenging for newcomers to the industry to fully grasp the key differences between these crucial concepts. So we have together this table to help simplify the process.

Commissioning – is essentially a non-regulated engineering test that brings a new plant or system into working condition. It’s a systematic approach to the start-up of a manufacturing system and covers all aspects of bringing a system or subsystem to a position where it is regarded as being ready for use in pharmaceutical (and other) manufacturing. The primary focus is placed on satisfying engineering requirements for the facility, defined earlier in the project.

Commissioning verifies that:

1. what was specified was installed
2. it functions properly
3. it was successfully turned over to the user

Regulation – Commissioning as an engineering process has no regulatory requirements.

Steps – Commissioning includes the following steps:

• Planning and preparation
• Equipment installation
• Infrastructure and utility verification
• Testing
• Handover to operations
• Continued monitoring

Costs – Its costs, rigour and volume of documentation depend on the engineering requirements for the facility, defined earlier in the project.

Qualification –is the regulated and documented act of proving that a mechanical, piping, software system or subsystem is installed correctly, operates as required and performs as expected under load.

While commissioning can apply to all of the equipment in a manufacturing facility, qualification applies only to equipment, systems, instruments and utilities that have a direct or indirect impact on product quality and patient safety. These critical systems will be focused on by the regulatory authorities when they come to approve the medicines that are being manufactured in that facility. We determine the impact by using system and component impact assessments and risk management tools.

Uses – Qualification is used for:

• Equipment
• Ancillary systems
• Instruments
• Utilities

Regulation – Qualification will be focused on by the regulatory authorities (FDA, EMA, etc) when they come to approve the medicines that are being manufactured in that facility.

Steps – Qualification includes the following steps:

• DQ (Design Qualification)
• IQ (Installation Qualification)
• OQ (Operational Qualification)
• PQ (Performance Qualification)
• URS (User Requirement Specification)
• FAT/SAT (Factory/Site Acceptance Testing)

Costs – Qualification is a rigorous, document-focused, time-consuming and expensive process.

If you need to learn how to develop an IQ IQ PQ equipment qualification protocol, check out our Equipment Validation (IQ OQ PQ) Training Course – For Starter Validation, CQV and C&Q Roles.

Validation –  is a broader term and describes the regulated and documented process of creating an evidence trail to show that an action, process or system leads to a consistent and reproducible result. There are many other definitions of validation but the essence of all these definitions seems to be “documented scientific proof of consistent performance“.

Validation is a central part of the manufacturing process within the pharmaceutical and medical device industries. The products made must be exactly the same every time and are tested at the end of the production process to ensure that this is the case but final end-product testing isn’t enough. Validation is an umbrella term that includes qualification.

Validation only applies to procedures and processes that have a direct or indirect impact on product quality and patient safety. We determine the impact by using risk management tools.

Uses – Validation is used for:

• Manufacturing Processes
• Cleaning
• Computer Systems
• Software
• Test Methods

Regulation – Validation will be focused on by the regulatory authorities (FDA, EMA, etc) when they come to approve the medicines that are being manufactured in that facility.

Examples – Validation examples include:

• Cleaning Validation
• Process Validation
• Analytical Method Validation
• Computer System Validation

Costs – Validation is a rigorous, document-focused, time-consuming and expensive process.

Whether you are building a brand new facility or modifying and existing plant, CQV practices are informed by a number of industry and regulatory guidelines such as:

• Annex 15: Qualification and Validation EU Guidelines
• U.S. FDA Process Validation: General Principles and Practices
• ISPE Baseline Guide 5 Commissioning and Qualification (Second Edition)
• ICH Q8) Pharmaceutical development
• ICH Q9 Quality Risk Management
• ICH Q10 Pharmaceutical quality system
• ASTM E 2500 “Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment”