Validation Services, Regulatory Affairs, and Compliance Requirements
Infolob is a specialized consulting firm in regulatory compliance, FDA inspection readiness, Quality Engineering and Validation Services for the Pharmaceutical, Biotechnology, Medical Device, and Nutraceutical industries. We have a solid track record of providing resolution for FDA compliance and validation issues. We help our clients ensure their facilities, utilities, and equipment perform as intended. We deliver fast and cost efficient solutions through focused qualification efforts.
We have well qualified and experienced teams with the technical skills and abilities to make our clients’ projects successful. we quickly adapt to the needs of each individual client, and understand each project has unique requirements. We use current industry trends and methods to help implement best practices.
Infolob Life Science provides professional services in Validation/Qualification, Compliance, Quality Assurance, Commissioning, Documentation Protocol and Regulatory Affairs.
Our services include:
- C3 Compliant, Cost effective, Commissioning
- Compliance Management
- Quality Systems
- Documentation Protocol
- Laboratory Services
- Qualification of Equipment
- Regulatory Affairs
- Training – GCP, GLP, GMP
Validation of your equipment and processes ensures you have system compliant with the FDA regulations and also provides confirmation that the system(s) are working as designed. Failure to follow FDA regulations and guidelines is the common source of 483 findings. Responding to those findings is costly and disruptive, especially when the validation is for legacy products, test methods, equipment, and processes.
- Validation Services
- Packaging Validation
- Facilities IQ/OQ/PQ
- Utilities IQ/OQ/PQ
- Equipment IQ/OQ/PQ
- Process Validation
- Test Method Validation
- Software Validation
- Master Validation Plan
- Cleaning Validation
A Protocol with comprehensive information of the sterility, packaging integrity, secondary and tertiary barriers are the essential requirements. Sample size and protocol execution with comprehensive reports where it will be demonstrated that key protections for the medical device product in transportation and storage requirements are satisfied.
Equipment, Facilities & Utilities Commissioning/Qualification
- Commissioning protocols and reports demonstrate that design requirements are met and are then ready to proceed to validation where it will be demonstrated that key environmental control and process utility supply requirements are satisfied.
- Installation (IQ), Operation (OQ), and Performance (PQ) qualification protocols and reports to demonstrate that equipment is installed properly, and can successfully roduce in-process and final products that meet specifications over the intended process parameter(s) operating range including worst case situations.
- Analytical, physical, mechanical, and visual test method characterization and validation protocols and reports demonstrate that the Manufacturing and Quality Control test methods can readily detect a nonconforming product with a high degree of assurance.
- Cleaning validation including determination of equipment process train vs. product use vs. cleaning method, determination of contamination limits, sampling methods and analytical test methods, and worst-case challenge testing.
Validation Master Plans, Procedures and Protocols
A comprehensive quality system record that captures the inventory of products and associated manufacturing processes, equipment, test methods, facilities and utilities and their validation status as well as plans to address new products or items and/or revalidation objectives.
PLC Control Systems and Software Validation
Computer validation following GAMP guidelines including user and functional requirements, risk assessment, and Software/Hardware Verification & Validation plans, protocols, and reports that demonstrate that automated manufacturing and quality systems meet all requirements.
Test method and Process Validation
Protocols and reports that demonstrate the overall production process, from start to finish, including all sub-processes can successfully produce final products that meet specifications under nominal conditions.
Establishing protocols to show the residual levels are with in the acceptable levels. This needs risk assessment of the process/product involved following the guidelines of the FDA. Cleaning validation could be incorporated into PQ part of process validation. This cleaning validation process demonstrates that the residues are down to acceptable levels and maintains the state of validation where only periodical testing is required.