Burgess Analytical Consultancy Limited
specialises in assisting clients to ensure 'fitness for purpose' of laboratory and quality systems and processes within the GxP regulatory
environment by providing expertise and training courses in;
- Qualification and Validation of automated analytical software and systems in laboratories including sensor technologies and automated testing equipment including CDS, NIR, Dissolution testing, LIMS, robotics etc.
- Analytical method development and validation.
- Stability testing and shelf life prediction
- Setting specifications for in-process controls, in- house limits for APIs and drug products
- Reference standards characterisation, manufacture and routine control.
- Data interpretation & statistical evaluation services including six sigma projects and OOS, OOE & OOT result investigations
- CAPA and Deviation Management
- Specifying, qualifying and validating NIR systems for raw material identification and PAT
- Product Quality Review
- Qualified Person services
- Supplier Quality assessment and auditing.
- Quality Risk Management and Risk-based cGMPs including redesign/and optimization of laboratory operations
- Implementation of electronic Quality Management Systems
- Auditing to GMP and ISO 17025. Supply chain quality, warehousing & distribution, APIs, finished products, excipients and IMP supply as well as Analytical Laboratories.
