QA & QC

Stability (ICH Q1A) Quiz 1

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Stability (ICH Q1A) Quiz 1 Q: What is the purpose of the revised ICH Q1A guideline mentioned in the text? A: The purpose of the revised guideline, based on the ICH Q1A guideline, is to establish the stability data package necessary for the registration application of a new drug substance …

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Quality Risk Management -Questions and answers

Quiz

Quality Risk Management -Questions and answers Q1: What is the purpose of Quality Risk Management in the context of medicinal products? A1: Quality Risk Management serves as a systematic process for assessing, controlling, communicating, and reviewing risks related to the quality of medicinal products. It encompasses both proactive and retrospective …

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Quality Control -Questions and answers

Clean Room Quiz 4

Quality Control Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released …

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Pharmaceutical Quality System – Questions and answers

Clean Room

Pharmaceutical Quality System Pharmaceutical Quality System – Questions and answers Q1: What is the main goal of a Pharmaceutical Quality System for medicinal product manufacturing? A1: The primary goal of a Pharmaceutical Quality System is to ensure the consistent delivery of medicinal products with appropriate quality attributes through the entire …

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Good Manufacturing Practice for Medicinal Products -Questions and answers

Good Manufacturing Practice for Medicinal Products Good Manufacturing Practice is that part of Quality Management which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation, Clinical Trial Authorisation or product specification. Good Manufacturing Practice is …

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Product Quality Review -Questions and answers

Product Quality Review Regular periodic or rolling quality reviews of all authorised medicinal products, including export only products, should be conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product, to highlight any trends and to …

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QMS Document Review

QMS Document Review QMS Document Review refers to the systematic examination and evaluation of key documents that govern quality management processes within an organization. It ensures compliance with regulatory requirements, internal policies, and industry standards. The primary objectives of document review are to maintain document accuracy, effectiveness, and alignment with …

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Validation of Pharmaceuticals: Ensuring Quality, Safety, and Compliance

Best Practices in the Validation of Pharmaceuticals: Ensuring Quality, Safety, and Compliance In the pharmaceutical industry, validation plays a crucial role in ensuring the quality, safety, and efficacy of pharmaceutical products. Validation is a systematic process that involves establishing documented evidence, using scientific principles and statistical methods, to demonstrate that …

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QUALITY MANAGEMENT SYSTEM IN PHARMA

QUALITY MANAGEMENT SYSTEMS IN PHARMA A QUALITY MANAGEMENT SYSTEM IN PHARMA (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A Quality Management system in Pharma helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its …

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Market Complaint -Stages of Handling

Market Complaint -Stages of Handling A market/consumer complaint is a notification that a product is in commercial distribution (which also includes a physician sample). it May be in violation of the laws or regulations administered by the FDA (Drug Control Authority) or May have caused an illness, injury, or death …

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QUALITY BY DESIGN AND SCALE – UP

QUALITY BY DESIGN AND SCALE – UP Unit operations are the individual basic steps in a process that when linked together define the process train and result in the final product. In practice, a unit operation is defined as an individual step that is carried out on one piece of …

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Retrospective Validation

Retrospective Validation The retrospective validation – to establish manufacturing procedures for products that are considered stable and resource limitations, prospective validation programs cannot be possible. Before initiation of retrospective validation, the numerical in-process and end-product test data of historic production batches are considered for statistical analysis, and the equipment, facilities, …

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Quality Excellence & Quality Culture Check

Quality Excellence & Quality Culture Check Addressing the sources of variability and defects is critically important when the failure rate is excessive or warranty obligations hurt profitability. The Quality Excellence Program helps business leaders, quality managers, and functional specialists to systematically improve process capability and consistently meet customer requirements at the lowest non-performance …

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