The BQG areas of expertise are closely aligned to the critical milestones in the Biopharma life cycle encompassing four practices: Engineering, Verification, Quality Operations, Quality and Process Control.
BQG has also utilised the extensive knowledge and capabilities of the team to develop the Apollo Maturity™ methodology.
Engineering – fully integrated practice using project management and engineering expertise designed to meet Good Engineering Practices, from design to handover.
Verification – practice to ensure the 1st GMP Batches are on schedule, on budget, and at the right quality. It includes Verification (phases I and II – from ASTM E2500 requirements), standard qualification & validation, and adapted risk management.
Operations & Quality Assurance – Practice covering quality assurance and Good Manufacturing Practices on manufacturing core processes and routine quality systems (deviations & investigations, CAPAs, change control, audit, recall, PQRs/APRs, etc).
Process & Quality Control – Practice aligning product & process robustness and quality control to reach the right level of quality and streamline the release process (sampling, testing, stability testing, analytical methods transfer and validation, OOS, etc.).
Leveraging these practices to increase in maturity...
BQG Apollo Maturity™ methodology – Based on the maturity improvement model used in other industries and developed specifically for the Life Sciences Industries. Apollo Maturity™ can be applied across all practices to provide our client with a ranking of their current quality systems and a road map of how they can progress toward their quality, compliance and performance objectives.