Quality Control Management

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By Bikash Chatterjee

Bikash Chatterjee emphasizes the criticality of utilizing the foundations of Lean and 6 Sigma in the paradigm of the drug improvement method. His advisor to operational excellence within the pharmaceutical and biotech industries is a targeted precis of the applying of Lean Six Sigma conception to the regulated existence sciences. From molecule discovery to the appliance of PAT employing Lean Six Sigma within the Pharmaceutical will spotlight the significance of framing those tasks in the key deliverables of drug improvement production and caliber. demanding traditional knowledge the writer bargains a high quality and potency standpoint as a starting place for the rules of caliber by way of layout, PAT and the hot philosophies underlying strategy Validation. every one bankruptcy comprises dialogue round the concerns for utilizing Lean production and 6 Sigma rules and their instruments, culminating in a case examine to demonstrate the applying. The publication is equipped to mirror the most important paintings facilities keen on the drug improvement lifecycle. each one bankruptcy is stand-alone yet jointly they illustrate the mandatory synergy among Lean, Six Sigma and compliance sensibilities required to achieve success within the pharmaceutical undefined. those layout, production and administration strategies usually are not with out their demanding situations. Bikash Chatterjee's ebook deals the roadmap for an that's suffering to reinvent lots of its improvement and enterprise strategies.

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Extra resources for Applying lean six sigma in the pharmaceutical industry

Example text

Lean initiatives that do not address these concerns at the outset have the potential for increasing efficiency while moving a process out of compliance. Quality risk management Quality risk management has become the hallmark of the modern QMS. ICH Q9 and Q10 speak directly to the process of risk management and its integration into a pharmaceutical QMS. The tools for risk management have been in place for many years and have even been used on occasion within the development lifecycle. Understanding the strengths and weaknesses of these tools is central to ensuring the appropriate risk management path forward.

Procedures should also define auditing activities such as the scope and methodology of the audit, selection of auditors, and audit conduct (audit plans, opening meetings, interviews, closing meetings, and reports). It is critical to maintain records of audit findings and assign responsibility for follow-up to prevent problems from recurring. Audit findings can be a useful tool when crafting OpEx initiatives. Lean projects in particular should pay close attention to the findings from internal and external audits as they will highlight both internal areas of concern as well as external regulatory concern.

Typical tools for achieving this level of reliability are establishing Incoming Quality Assurance Inspections and Testing (IQA), utilizing supplier audits in combination with a risk-based prioritization scheme to ensure critical suppliers and contract manufacturers provide input material that will perform as expected. Once a history of process stability has been established, input materials can move from an IQA approach to a Certificate of Analysis (COA) or Certificate of Compliance (COC), supplemented with periodic reassessments.

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