INFOLOB’S ROLE IN LIFE SCIENCES
Infolob Solutions provides specialized consulting services for the pharmaceutical, biotechnology, medical device, and nutraceutical industries. We have a solid track record of providing FDA compliance and validation issue resolution and help ensure that our clients’ facilities, utilities, and equipment perform as intended.
Equipment and process validations ensure that your systems are compliant with FDA regulations and provide confirmation that they are operating as designed. Failure to comply with FDA regulations and guidelines is costly and disruptive, particularly when involving legacy products, test methods, equipment, or processes. Infolob provides the following validations:
- Essential requirements include proper sterility, packaging integrity, and secondary and tertiary barriers.
- Infolob provides a sample size and protocol execution with comprehensive reports demonstrating that key protections and storage and transport requirements are satisfied.
Master plans, procedures, and protocols
- Provision of a comprehensive quality system record that captures product inventory and associated manufacturing processes, equipment, test methods, facilities, and utilities along with their validation statuses.
- Plans to address new products or revalidation objectives.
PLC control systems and software validation
- Adherence to GAMP guidelines, including user and functional requirements, and risk assessment.
- Software/hardware verification and validation plans, protocols, and reports demonstrating that automated manufacturing and quality systems meet requirements.
Test method and process validation
- Protocols and reports demonstrating overall production process from start to finish.
- Proof that sub-processes can successfully produce final products under nominal conditions that meet specifications.
- Demonstrates that residues are within acceptable FDA-approved levels.
- Maintains the state of validation where only periodical testing is required.
Equipment, Facilities, and Utilities Commissioning/Qualification
- Protocols and reports demonstrating that design requirements are being met and are therefore ready to proceed to validation. Validation, in turn, demonstrates that key environmental control and process utility supply requirements are satisfied.
- Installation (IQ), operation (OQ), and performance (PQ) qualification protocols and reports demonstrating that equipment is installed properly and successfully produce in-process and final products. Products must meet specifications over the intended process parameters and operating ranges, including worst-case scenarios.
- Analytical, physical, mechanical, and visual test method characterization and validation protocols/reports demonstrating 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 and analytical test methods, and worst-case scenario testing.