Validation

For today’s winners in the pharmaceutical and allied industries, we recognise that the emphasis is increasingly shifting away from traditional issues such as patent expiry, low cost base, falling prices and falling numbers of New Chemical Entities (NCEs), towards the requirements for increased technical complexity and increased regulatory controls.

We believe in delivering added value to everything we do: our approach to cGMP compliance is one aligned with cGMP21 and is based on pragmatic risk analysis applied to a detailed understanding of the manufacturing process. Our specialists have extensive experience of the design and operation of biotechnology, pharmaceutical and other manufacturing facilities as well as hands-on experience of working with and for the regulatory authorities.

Our expertise means that we can answer some of the most difficult questions.

How do I incorporate validation requirements effectively within project scopes?
How much validation effort do I really need?
How can I qualify a new plant or process upgrade as quickly as possible?
How can I validate plant modifications and projects at minimum cost?
How do I prevent validation becoming a retrospective exercise applied to my projects?
How do I apply a risk-based approach to my validation activities?
How can I reduce my costs for auditing my supply chain?

We use a pragmatic, integrated approach to compliance and validation activities, ensuring sound documented compliance with cGMP for all our bio/pharmaceutical assignments. We provide consultative support, undertake full validation services associated with manufacturing projects, and retrospectively validate existing processes.

Specific services we provide to our clients include:

validation master planning
conducting design reviews and DQ audits
undertaking system development in accordance with GAMP and CFR21pt11
preparing and executing IQ, OQ and PQ protocols ensuring compliance with URSs
preparing Standard Operating Procedures (SOPs)
preparation of final validation reports
mock audits and inspections by a Qualified Person (QP) to the level carried out by FDA, EMEA, MHRA
liaison with appointed Regulatory Inspectors
third party supply chain audits
establishing programmes for:
- co-ordinating construction documentation
- capacity estimation
- establishing equipment history files
- calibration
- preventative maintenance
- training
- change control.