We have the experts to support you at every step of your process, whether it be non-compliance issues, setting up a new process, or training employees. Our team has the background and education you need. Their ongoing dialogue with different regulatory agencies provide a continuous update of new regulatory requirements.
Advisory services
Sterility Assurance
- Develop a Corporate Sterility Assurance program
- Training, development, and qualification for steriliziation and depyrogenation
- Aseptic Process revision and/or Facility Design
- Revision of production deviations, non-conformities, and other investigations
- Resolution of FDA 483, EMA or local authority compliance deviations
- Validation of microbial sampling systems and isolators for sterility testing
Quality by Design (QbD)/Process Analytical Technology (PAT)
- Advice on how QBD / PAT may be incorporated in the business system
- Applying “Comparability Protocols” and other regulatory strategies for deployment
Pharmaceutical Microbiology
- Environmental monitoring evaluation and development
- Evaluation and development of protocols and cleaning procedures
- Evaluation and development of procedures, policies and standards for media fills
- Laboratory Management
- Optimization of laboratory policies, procedures, equipment, and methods
- Sterility test analysis and evaluation of positive sterility failure tests.
- Development of rapid methods for sterility testing
- Microbiological Data Deviations (MDD) and Analysis of Out-of-Specification (OOS)
- Program development and review of microbiological
data deviations and out-of-specification
- Implementation of corrective action plans for reducing and/or eliminating MDD or OOS
Alternative Microbiological Methods
- Methodology review and education
- Management approval, project management, and implementation support
- Market analysis and advice on needs and product specification development for RMM
Production Support
- Process optimization, risk assessment, and project management assistance
- Comparability protocols for processes/analytical changes
- Cleaning and sanitization of cleanrooms including process analysis, practices, procedures, and rationales/rotations
Quality Assurance Support
- Development of Quality Management Systems (QMS)
- Evaluation of systems based inspection compliance programs
- Support implementation of quality problem solving tools
- Assist in inspection resolution, reduction, and root cause analysis
Risk Assessment
- Performed using Failure Mode and Effects Analysis (FMEA), Hazard Analysis (HACCP), and other methods
- Evaluation of laboratories, production, and quality operations
- Development of programs and procedures
- Review of data trends and recommendation of alert and action levels
- Risk Assessment for EM sampling locations
Training
Our experts provide onsite training including:
- Fundamentals of microbiology
- Personnel hygiene GMP
- Contamination control
- Cleanroom protocols
- Cleaning and sanitization GMP
- Alternative microbiological methods implementation
- Risk assessment management
- Media-fill protocols
- FDA and EU guideline interpretation
- Regulatory updates
- Training courses for professional development tailored to your needs
EXPERT REVIEW OF OPERATIng PROCEDURES AND PROCESSES
We offer training of operators and analysis of process operations at your facility for:
- Operators in production areas
- Supervision of pharmaceutical processes
- Quality Assurance and Quality Control Laboratories
- Engineering and Maintenance personnel
- We can also provide evaluation tests for competency and training certificates
How can we help?