Expert Cleanroom Consulting Services
Your partner in cleanroom excellence and compliance.
Consulting Services for Cleanroom Applications
Cleanroom Management Experts
Paldron specializes in all areas of cleanrooms and controlled environments. We offer a systematic and professional program of contamination control, including competitive benchmarking, training, and auditing of clean and aseptic operations. Our services also include installation and validation for clean room capital equipment, as well as responding to FDA 483 observations.
Consulting Services for Cleanroom Applications
Consultative Services
- Responding to FDA 483s, inspections, Warning Letters and other compliance issues, meeting with FDA to resolve disputes, implementing corrective and protective action (CAPA) programs, and assisting with “a third-party role under a consent decree”
- Document preparation and review (including NDAs, INDs, ANDAs, NADAs, and DMFs)
- Continuous Improvement
- Risk Assessment and Risk Management for production areas (sterile and not sterile)
- Environmental Monitoring process and solutions
- Data Governance and Data Integrity
- Compliance with adverse drug event (ADE) management/reporting including process deviation management
- Review of product labeling, advertising/promotional materials for regulatory compliance
- Regulatory affairs consulting with strategic assistance
- Preparation of protocols, reports, policies, etc.
- Training on FDA and EMA -related topics (including fully custom programs to meet client needs)
- SOP Review
- Assistance with regulatory activities including pre- and post-approval submissions, strategic planning, and FDA/EMA meeting preparation
- Implementation and support in their validation of alternative microbiological methodologies in pharma industries
- Quality by Design strategy
- Support in EU GMPs Annex 1:2022 assessment and compliance (gap analysis and remediations plans)
- Strategies, documentation and support (Validation and regulatory submission) for the implementation of alternative microbiological solutions/equipment
Additional Products & Services
EQUIPMENT SOLUTIIONS
QUALIFY, INSTALL, VALIDATE, PM, SVC
EQUIPMENT SOLUTIIONS
- Fixed & Portable Total Particle Counters and Microbiological active air samplers
- Mobile and Fixed Biodecontamination Systems
- Glove Integrity Test
- Qualification Instruments Devices
- Real Time Microbial Monitoring
- TOC Analyzers
- Isolators
- Washers
DOCUMENTAION
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EQUIPMENT SOLUTIIONS
- 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, help
- 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.
QUALIFY, INSTALL, VALIDATE, PM, SVC
QUALIFY, INSTALL, VALIDATE, PM, SVC
QUALIFY, INSTALL, VALIDATE, PM, SVC
- Installation of fixed monitoring systems (total particles and microbiological) including physical sensors (DP, HR%,°T, etc.)
- Qualifications (IQOQ & PQ)
- Preventative Maintenance
- Calibration
- ISO 17025:2018 accredited laboratory services