We work closely with you, and as your partner in validation we find the right team member for your organisation and project, ensuring a technical and cultural match. With access to state-of-the-art technology during their training, our team of technical consultants gain robust technology, analytical and data processing skills.
Our technical training is hands-on utilizing our pilot-scale process facility. This includes the major technology platforms of blending, fluid-bed drying/granulation/coating and compression. Our team are equipped with extensive multi-faceted technical knowledge combined with the highest standard of report and protocol writing skills.
Analytical and data processing skills are developed through use and understanding of Innopharma Technologies PAT tools and time spent in our Quality Control Analytical lab.
We place a strong focus on soft skills during our selection process and throughout our continuous personal development training.
Innopharma Technical Services — Your Partner in Equipment/Utility Qualification
Delivering Expertise In:
- CQV, V Model and ASTM 2500
- System Impact Assessment
- Risk Assessments and Testing Matrix
- Facility & Utility Qualification and The Quality Standards for Clean Utilities
- High Containment, Isolators and RABS
- Packaging Validation, Primary & Secondary Packaging, Serialisation
- Temperature-Controlled Storage and Temperature Mapping Studies.
- Medical Device Qualification and ISO13485
Innopharma Technical Services — Your Partner in Process Validation
Delivering Expertise In:
- Oral Solid Dose Processing, from Dispensing through all the Major Technology Platforms of Blending, Wet/Dry Granulation, Milling, Compression Coating to Finished Product Release Testing
- Biopharma Processes (Upstream & Downstream)
- Sampling Plan Development including Representative Sampling, Testing Requirements and Generation of Validation Acceptance Criteria
- Regulatory Requirements of Process Validation Lifecycle (stage 1-3)
- Process Validation Strategy including Protocol and Report Generation
- Statistical Analysis and Data Visualisation
- RCA and CAPA
Innopharma Technical Services — Your Partner in Cleaning Validation
Delivering Expertise In:
- Cleaning Validation Strategy Including Protocol and Report Generation
- The Matrix Approach to Cleaning Validation, Identifying the Worst-Case Scenario
- CIP, COP, Manual Clean and SIP
- Sampling Techniques for Cleaning Validation (Swab & Rinse Samples)
- Worst Case Conditions e.g. Campaign Duration, Dirty/clean Hold Times
- Sampling Plan Development Including Hard to Clean Areas, Testing Requirements and Generation of Validation Acceptance Criteria (MACO, ADE)
- Aseptic Practices and Sterilisation Techniques
- RCA and CAPA
