Onerous validation requirements, never-ending piles of documents, and the constant worry that a small mistake is just waiting for an auditor to find it. If you work in pharmaceuticals or another life sciences field, this probably sounds all too familiar.
Apart from leaving you stressed, these obstacles often spill over into other areas, slowing down production and making it hard to stay focused on your real mission – supplying safe, reliable products to the patients and customers who need them.
So, what steps can you take to make things easier? The Good Automated Manufacturing Practice version 5 (GAMP 5), a highly regarded resource in life sciences and pharmaceuticals, can really help. It makes validation easier to understand, helps you cut down on paperwork, and presents a risk-based approach to compliance.
If GAMP 5 is new ground for you, that’s no problem. This guide will explain what it is, why it matters, and how it can improve the valuable work you do.
Intro to GAMP 5
GAMP 5 – is the latest version of a resource created by the International Society for Pharmaceutical Engineering (ISPE). And since 2022, GAMP 5 has helped pharmaceutical professionals design, check, and manage automated and computerized systems throughout their entire lifecycle.
The publication offers advice on getting these systems fit for use and in line with regulatory requirements. For example, GAMP 5 is widely used as a trusted guide in the pharmaceutical industry to help make sure medicines are produced safely.
Instead of getting caught up in the small details of a system, GAMP 5 presents a risk-based approach to validation, pinpointing the most important areas of product quality and compliance.
Keep in mind: GAMP 5 is well-known for guiding Computer System Validation (CSV), but it’s not limited to this. Beyond validating computer systems, it’s also used for Commissioning, Qualification, and Validation (CQV) processes. This makes it helpful for various automated systems in pharmaceutical manufacturing, including compliant GxP computerized systems.
Is GAMP 5 an official regulation?
GAMP 5 itself isn’t an official regulation. But it can help you meet the official compliance requirements that are set out by regulators like the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA). For example, regulatory requirements that support patient safety, data integrity, and the quality of your products.
GAMP 5’s guidelines are widely used by regulated companies in pharma and beyond to meet regulatory requirements that support patient safety, data integrity, and product quality. So, while not mandatory, we recommend it as a reliable and valuable resource to keep close at hand.
GAMP 5 scope and key processes
Let’s take a closer look at how GAMP 5 helps life sciences professionals design, test, and maintain their systems to meet the highest quality and safety standards.
Holistic system approach
GAMP 5 suggests looking at the whole system – software, hardware, operating systems, and automation – as one big picture. This means thinking about how each part interacts and relies on the others at every stage from design to testing to full operation.
Framework for planning, testing, and validation
When reading GAMP 5, you’ll gain insights into how to plan, test, and validate systems properly (in line with official regulations from organizations like the FDA or EMA). Using this framework will make you more confident that your system is working as it should and is safe for pharmaceutical production.
Document management
In the life sciences industry, it’s important to keep your records organized, traceable, and compliant with regulatory requirements. GAMP 5 makes document management easier by providing clear guidelines on how to document every step of the system lifecycle.
GAMP 5’s role in digital transformation
The life sciences industry is adopting new technologies all the time. Luckily, GAMP 5 is keeping pace. In fact, the ISPE GAMP Community of Practice (CoP) regularly reviews and updates GAMP best practices to match the latest technology and regulatory changes.
At the moment, pharmaceutical companies are using tools like cloud computing, AI, and Internet of Things (IoT) to speed up production and make smarter decisions with real-time data. GAMP 5 supports this shift with guidance on validating these modern systems.
And because software development isn’t a one-size-fits-all, straight-line process, GAMP 5 takes a flexible, step-by-step approach to help you keep improving your software as it changes and grows.
Take cloud computing, for example. GAMP 5 gives you practical tips on checking that data storage and access meet security and regulatory rules. Plus, it shows how using smart software tools and automation can keep your systems running well from start to finish.
Who should use GAMP 5?
GAMP 5 isn’t just for computer experts or people with “validation” in their job title. It’s useful for anyone working with computerized and automated systems in pharmaceutical or life sciences companies, including:
- Quality Assurance (QA) teams: When reviewing how automated systems are built and tested, GAMP 5 shows QA specialists what to look for. This guidance helps ensure quality risk management and that systems meet safety standards.
- IT and automation teams: Professionals who design, build, or support automated systems (like production lines or software that controls machines) can use GAMP 5 to be confident everything is running in line with regulations.
- Validation and compliance specialists: GAMP 5 gives these specialists a structured way to check that automated systems are working as they should – without wasting time on low-risk areas. This makes computerized system validation easier and ensures it meets the necessary rules and standards.
- Engineers: Engineers who design equipment or work with manufacturing processes can use GAMP 5 as a guide to bring together hardware, software, and automation, helping them stay productive and compliant.
- Project managers: If a company is installing a new system (or updating an existing one), project managers can use GAMP 5 to guide timelines, tasks, and team responsibilities.
How much does GAMP cost?
GAMP 5 prices vary depending on whether you’re an ISPE member or not. Members get the guide for $395 USD – nearly half the non-member price ($770 USD).
There’s also special pricing for professionals in emerging economies, making it more affordable worldwide.
Make validation easier, smarter, and faster with Kneat
If you’re looking for reliable software to streamline your validation strategy and meet regulatory standards, Kneat is here to help.
Our team is dedicated to simplifying the validation process, from document management and review to approval and testing execution – all within a single, user-friendly digital validation platform. We align closely with the GAMP 5 framework, ensuring our validation solutions follow industry best practices with a risk-based, compliant approach.
Our flagship product, Kneat Gx, is a cloud-based system that enhances compliance through automatically generated audit trails, streamlines validation with online testing, and boosts collaboration with secure, central document access. Crucially, it’s scalable. If you need to support unlimited users, processes, protocols, or facilities, Kneat can grow with you.
We’re proud to work with 8 out of 10 of the world’s leading life sciences companies and would love the opportunity to work with you next.
