FDA's New Guidelines Help Reduce Cross-Contamination in Pharmacy and Bio-Tech Industries

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					Compliance Insight, Inc.
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                FDA's New Guidelines Help Reduce Cross-Contamination in
                           Pharmacy and Bio-Tech Industries


(Fairfield, Ohio) Compliance Insight Inc., a regulatory and quality assurance consulting firm,
discusses the FDA’s new guidelines regarding pharm and bio-tech cross-contamination.
The FDA report 'Pharmaceutical Quality for the 21st Century: A Risk-Based Approach' lays
emphasis on the Quality-by-design approach for process validation. It includes – Process
Development, Process Analytical Technologies, and Corrective and Preventive Actions
(CAPA). Michael R. Goodman, compliance specialist, Compliance Insight that these new
guidelines for validation in Current Goods Manufacturing Processes (cGMP) specifically
help reduce cross-contamination in pharmacy and bio-tech industries.

The FDA’s suggestions include:
• Extremely strict quality and process controls.
• Use of PAT (process analytical technologies) which are based on tools, multivariate data
acquisition and analysis, process analyzers, and process controls.
• No compromises with public safety.
• More consolidations, collaborations, and alliances in the industry.
According to Goodman, reducing cross-contamination is easily possible by doing the
following:
• Implementing the Quality-by-design validation process and other modern ideas of
pharmaceutical development being used by the best in the industry.
• Making no compromises with the quality systems at any stage of the manufacturing life
cycle.
• Implementing proper risk management process of the highest quality at every step.

For example, the first phase of the clinical trial should include initial process validation,
design process validation, and equipment evaluation. A range assessment research study
should also be adopted. The study should conclude what is the acceptable range, critical
steps, and list the specifics required for successful scale-up. There would be no need for
tech-transfer validation at either the contract-manufacturer or collaborator level if proper
transparency is maintained in research.

Consider the following in order to adhere to the FDA guidelines for risk-based analysis of
facility and equipment:
• How do daily and normal operations affect quality?
• What are the equipment-tolerance factors?
• Is there optimum interaction connecting equipment material, systems material, and in-
process material?

The idea is to use equipment that has the maximum efficiency and accuracy. The best
technique is to ensure that at least a minimum of three consecutive batches are used for
validation. Cross-contamination is avoided by dedicating a single product line to just one
product. This might not be possible for several companies. Therefore, such companies
should set a strict but acceptable health-based limit for carryover of production lines. The
limit should be based on the last cleaning agent or product that was used for a particular
production line.

Pharmaceutical companies must regulate and monitor their dependence upon CMOs
(contract-manufacturing companies). This dependence upon CMOs has increased over the
last several years. Therefore, pharmaceutical companies must maintain strict audit
parameters for all these companies.

Compliance Insight, Inc. specializes in Regulatory and Quality Assurance consulting and
training for pharmaceutical, nutraceutical, medical device, chemical, and bio-technology
companies in North America, Europe and Asia.

For more information visit http://compliance-insight1.com/

				
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posted:10/22/2012
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