GxP Validation
Your GxP Expert
Synertec’s GxP consultants assist clients in achieving project objectives using a risk-based approach. Our subject matter experts (SMEs) collaborate with various functional teams in manufacturing, validation, and quality to identify the optimal solution for each validation project thus reducing costs and labour.
Synertec's GxP capabilities
- Process Design
- Process Qualification
- Process Verification
- Evaluation of existing process
- Closing compliance gaps
- Improving efficiencies
- Setting up cleaning validation matrixes based on worst case products
- Validation of cleaning processes
- Establishment of health-based exposure limits (PDE)
- Investigating cleaning issues, troubleshoot CIP & COP systems
- Optimising cleaning processes
- Training programmes
- Selection of sampling method and swabbing
At Synertec we have SMEs in Process Validation, Cleaning Validation and Computerised Systems Validation.
Our experienced consultants can support your company to achieve process validation compliance by ensuring the manufacturing process effectively controls the quality of the final product.
We help our clients to identify the Critical Process parameters (CPP’s) and Critical Quality Attributes (CQA’s). Together we will work with you to take a product lifecycle management approach to process validation.
Cleaning validation ensures that equipment-cleaning procedures accurately remove residue to predetermined levels of acceptability. Reaching predefined levels of hygiene on product contact surfaces has become a priority in the pharmaceutical, healthcare and food industries.
Our qualified validation consultants have the expertise to develop and improve your cleaning validation program and procedures and will help you understand and navigate the current cleaning validation regulations.
Other Validation Solutions
The term ‘Validation’ is broad in scope and reach. It may refer to a study demonstrating that a facility complies with relevant regulatory requirements, or it may refer to an exercise showing the qualification of a specific plant process against a particular standard, or it could relate to an investigation to confirm the test results of a flow monitoring system are accurate to within the required tolerances via a secondary testing regime.
Synertec is certified to ISO 9001 (Quality), ISO 14001 (Environment), and ISO 45001 (Occupational Health & Safety). We understand what it takes to develop and maintain compliant systems and to support our clients with their own performance and compliance requirements.
Our experience and knowledge are centred around a team of expert engineers and scientists who have a deep understanding of the technology and processes across a wide range of industries and have hands-on experience implementing compliant solutions for these industries.
Synertec’s experience in delivering large scale industrial solutions is supported by our commitment to security, adhering to ISO 27001, Information security, cybersecurity and privacy protection.
Get in touch today to see how Synertec could help with your next project.
