J-GMP are an authority on industry standard validation. Our expertise allows us to offer a solution to all your validation needs.
We have extensive expertise in pharmaceutical, API and medical device manufacturing equipment. We employ risk management techniques and offer competitive advantage over allowing vendors and manufacturers to qualify equipment.
We have been involved in new builds and refurbishments. We can help design effective approaches in line with standard requirements.
Computer system validation can be complex. Let us simplify it for you.
We can undertake procedure and protocol writing, including the PDE (permitted daily exposure) approach.
Analytical Method Validation
Our offering covers protocol writing, or a fully managed service in line with ICH requirements.
Our process services include protocol writing, supervision of execution and report writing.
Gap Assessment, Planning, Remediation
We can carry out rapid assessments and develop remediation plans where required. Our knowledge in validation planning means we can write and manage master or project validation plans.
We can design risk-based approaches to limit the amount of validation required.
We’re always here to help, if you’re in need of a long-term management service, we can ensure you remain compliant.
We offer assistance with equipment and software validation and project management in order to fulfil your serialisation commitments.