J-GMP is passionate
about validation

J-GMP are an authority on industry standard validation. Our expertise allows us to offer a solution to all your validation needs.

Equipment Qualification

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.

Utility/Facility Qualification

We have been involved in new builds and refurbishments. We can help design effective approaches in line with standard requirements.

CSV

Computer system validation can be complex. Let us simplify it for you.

Cleaning

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.

Process validation

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.

Risk-based Solutions

We can design risk-based approaches to limit the amount of validation required.

Continual Support

We’re always here to help, if you’re in need of a long-term management service, we can ensure you remain compliant.

Serialisation

We offer assistance with equipment and software validation and project management in order to fulfil your serialisation commitments.

Get in touch and we will be happy to advise you.

Contact Us