Quality Risk Management in Pharma

Posted on April 29, 2022May 10, 2022Categories General, Quality & Validation

As per Health Canada Guidance on GMP, GUI-0001, Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of a drug across the product lifecycle [1]. In other words, the risk Management is defined as the identification, analysis, assessment, control, and avoidance, minimization, or elimination of unacceptable risks [2].

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Benefits of using Design For Six Sigma (DFSS) Methodology

Posted on November 14, 2021February 13, 2022Categories Lean Six Sigma

Design for Six Sigma (DFSS) is a structured approach to designing new products, processes and/or services to meet or exceed customer requirements and expectations. DFSS provides a more systematic way to manage the deliverable, resources, and trade-offs. It helps to deliver better products and services that your customers want and willing to pay for at Six Sigma Level.

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How to implement a Good Validation Master Plan (VMP)

Posted on June 24, 2021November 4, 2021Categories Quality & Validation

Definition

Validation Master Plan is an approved written plan of objectives and actions stating how and when a company will achieve compliance with the GMP requirements regarding validation. It is a document which defines the intentions and the methods that are related with validation of facilities, utilities, system, equipment, instruments, materials, analytical methods, It Systems, cleaning procedures and processes.

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