Applying lean six sigma in the pharmaceutical industry by Bikash Chatterjee

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By Bikash Chatterjee

Bikash Chatterjee emphasizes the criticality of making use of the rules of Lean and 6 Sigma in the paradigm of the drug improvement approach. His advisor to operational excellence within the pharmaceutical and biotech industries is a targeted precis of the appliance of Lean Six Sigma concept to the regulated existence sciences. From molecule discovery to the appliance of PAT utilizing Lean Six Sigma within the Pharmaceutical will spotlight the significance of framing those tasks in the key deliverables of drug improvement production and caliber. tough traditional knowledge the writer bargains a high quality and potency standpoint as a origin for the rules of caliber via layout, PAT and the recent philosophies underlying method Validation. each one bankruptcy comprises dialogue round the issues for employing Lean production and 6 Sigma rules and their instruments, culminating in a case learn to demonstrate the appliance. The booklet is geared up 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 concepts usually are not with no their demanding situations. Bikash Chatterjee's publication deals the roadmap for an that's suffering to reinvent a lot of its improvement and company tactics.

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HACCP has been recognized as a useful and effective risk management tool by the FDA for some time and became a mandatory component of the FDA’s regulation for all seafood processing plants in 1997 and has been mandatory for canned food manufacturers since 1973. HACCP is intended to be a structured way to easily analyze and document risk within a process or piece of equipment. The basic steps for conducting a HACCP are: 36 Applying Lean Six Sigma in the Pharmaceutical Industry • flow chart the process; • identify any hazards that must be prevented, eliminated, or reduced to acceptable levels; • identify variables that can cause the hazard (Design of Experiments or other tools); • identify the critical control points in the process where those variables are impacted/affected; • establish critical limits for those variables beyond which the hazard is created; • determine and implement effective monitoring procedures at critical control points; • determine corrective actions when monitoring that indicate that a critical control point is not under control (adjustment, maintenance, and so on); • establish records of control and correction.

They are: 18 Applying Lean Six Sigma in the Pharmaceutical Industry 1. design, develop, and document product and processes; 2. examine inputs; 3. perform and monitor operations; 4. address non-conformities. Design, develop, and document product and processes The FDA guidance cites the need to ensure the product and process is defined from design through commercial introduction. Procedures must be in place to define responsibility for development, scale-up, technology transfer and commercial manufacturing along with all supporting operations such as quality control sampling, maintenance and calibration, and batch documentation.

Control of outsourced operations. General arrangements Ironically this is an integral component to presenting a defensible QMS and is a problem faced by many start-up ventures that are focused on product development. The structure and resources must be sufficient to convey that the organization is capable of effectively administering the QMS and operate in a cGMP manner. At a minimum, senior management is responsible for demonstrating there are adequate resources: The Product Lifecycle and Quality Philosophy 15 • to supply and maintain the appropriate facilities and equipment to consistently manufacture a quality product; • to acquire and receive materials that are suitable for their intended purpose; • for processing the materials to produce the finished drug product; • for laboratory analysis of the finished drug product, including collection, storage, and examination of in-process, stability, and reserve samples.

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