Growing Regulatory Compliance Issues

In the life science business, there's nothing more important than the manufacturing process. Few companies can match the expertise of FW Biokinetics in process design, one of our traditional strengths. We are recognized in the industry for our ability to combine proven cGMP design, new technologies, and innovative problem solving to create the best system solutions for our customers.

The job of a Quality Manager has gotten tougher these days. FDA 483 letters are on rise and the debate rages over the variety of reasons for this trend, which began in 2010 and has not abated in 2011. Developing a program for regulatory compliance is a daunting task especially when so many drugs are being manufactured globally, and are being impacted by multiple regulatory agencies and requirements. The principal regulatory issue facing manufacturers today is that global requirements are not fully harmonized.

Other trends affecting regulatory, validation and compliance issues are the abundance of mergers of different sites, and quality cultures. Have you experienced the re-evaluation of your site, as the "purchased" company, to ensure that your compliance and validation procedures are in sync with the new owners? Many quality managers in pharmaceutical processing plants think they are in compliance, but such is not always the case.

FW Biokinetics has over four dozen individuals dedicated to ensuring that your facility is in compliance now. In the biopharmaceutical industry, where knowledge and experience are keys to success, FW Biokinetics leads the industry in the breadth and depth of process and regulatory expertise. Our experts have extensive process knowledge gleaned through years of specializing in biologics manufacturing and will ensure that your process meets FDA requirements and all other applicable regulatory agencies and that the integrity of your drug is suitably protected as it moves throughout your facility.

We have an extensive database of programs that we have developed for our clients to achieve regulatory compliance. This includes development of compliance programs, remediation following regulatory observations, assisting during regulatory audits and conducting internal audits and gap assessments.

Permanent staff of over 40 Regulatory and Validation Specialists
Proven success in remediation and program development
In depth understanding of regulatory requirements and expectation worldwide
Extensive database of programs, assessments, audits, SOPs, and requirements

Have a new facility or process or are contemplating entering conceptual design phase for a new process? Call upon the CQV group at FW Biokinetics early on, or bring us in as an objective "third eye" to ensure the on-time delivery of a commissioned and validated process. Don't wait until the engineering is done and construction starts - get Christine Dell Cioppia and her FW Biokinetics CQV group to perform a gap analysis for your manufacturing facility today.

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Gap Analysis Checklist

aQualification/Validation process review and recommendations
aChange Control
aPeriodic Review set-up and recommendations
aProcess for non-conformances
aTraining Program for your Quality Staff
acGMP Documentation Practices
aDocument Control
aCalibration and Preventative Maintenance Programs
aEquipment and Quality SOPs
aBatch Records Documentation
aWarehouse and Inventory Control Practices
aProcess for Determining Acceptance Criteria