Documentation Services

Optimize Your Aseptic Processing

Standard Operating Procedures (SOPs)
Sampling Plans: Comprehensive plans outlining the methods and frequency of environmental sampling, including air, surface, compressed gases, utilities and personnel monitoring.
Risk Assessments: Evaluations of potential risks associated with microbiological contamination and environmental factors, helping to identify critical control points and mitigation strategies.
Statistical Justification: Documentation providing the rationale for sampling frequencies and locations, often based on statistical analysis and risk assessment.
Investigation Records: Detailed reports of any investigations into contamination events or deviations, including root cause analysis and corrective actions.
Trending Reports: Analysis of environmental monitoring data over time to identify trends and potential issues before they become critical.
Validation Protocols and Reports: Documents related to the validation of environmental monitoring methods and equipment, ensuring they are fit for purpose and meet regulatory requirements.
Training Materials: Resources to train staff on proper microbiological and environmental monitoring techniques, ensuring everyone is knowledgeable and compliant with SOPs.
Regulatory Compliance Documentation: Ensuring all practices and documentation meet the requirements of relevant regulatory bodies, such as the FDA, EMA, or other local authorities.