Validation & Compliance
We provide specialised validation services (both document creation and execution) and the project management of validation activities of equipment, facilities, and utilities.
We can assist clients to ensure that the introduction of processes and process equipment is undertaken in such a manner that it can be fully validated in accordance with regulatory requirements.
We can execute the client’s own protocols or we can offer the services of our team of specialist to write and execute documentation according to full Good Documentation Practices: We are happy to work flexibly with clients; you only pay for what you want!
- Risk Assessments
- GMP review, gap analysis and preparation of remediation plans.
- PIA readiness preparation
- Design Qualification
- Master validation plans
- Validation Plans
- Validation protocols (IQ / OQ)
- Process validation
- Validation reports
- Re-validation plans and protocols
- Retrospective validation
- FAT and SAT acceptance protocols and testing
We specialise in working with clients to ensure that both processes and equipment are introduced in a compliant manner that will fully meet validation and EU & FDA regulatory requirements. Part or full turnkey service.
Our protocols are individually created to ensure that they comply with client’s URS’s, standards and SOP’s and to the client’s timeframes even if the timelines are short. We can help clients define appropriate acceptance criteria.
We offer full validation services associated with manufacturing projects as well as offer services to retrospectively validate existing manufacturing processes.
Our skilled personnel can work with your operations and quality groups to generate process validation protocols, facilitate execution, collate documentation, and generate reports.
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Why choose Blue Hatch for Validation and Compliance?
- We have over 40 years’ experience within pharmaceutical validation and compliance.
- Expertise in Equipment, facility, utility qualifications.
- Experienced in performing Process Validation compliant with all EU and FDA Regulatory Requirements.
- Our validation, engineering and technical experts work together to provide you with a holistic service.
- We can work within your own validation plans, or can create master plans and SOPs for you, or can develop a full validation strategy for you.
- Can act as Subject Matter Experts for you for audits and regulatory inspections.
- Can act as an independent consultancy or as additional resource to your own teams.
- From design Qualification and Factory Acceptance Tests through to PQ
- We can provide custom designed validation and compliance systems and strategies to maximise the effectiveness of your Quality System.
- We can provide customised training and mentoring.