Search results for " ICH"
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Assessing Manufacturing Process Robustness
ICH guidelines Q8–Q12 (1–5) and those in development such as ICH Q14 (6) have applied science, risk management, and quality systems to enhance process and product quality.
In 2011, …
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Understanding Validation and Technical Transfer, Part I
In 2000, ICH Q7A defined validation as, “A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determi…
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Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…
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Efforts Accelerate to Streamline Postapproval Change Process
The ICH Q12 program also seeks agreement on basic postapproval reporting categories set by regulatory authorities and where and how to list ECs in dossiers (1). And by encouraging greater reliance on …
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Using Quality by Design to Develop Robust Chromatographic Methods
The concept of quality by design (QbD) was introduced to the pharmaceutical industry in the International Conference on Harmonization (ICH) guidance documents, ICH Q8-Q11 (1-4), as a way to develop ro…
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Essentials in Quality Risk Management
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
Quality risk management (QRM), as defined in Internatio…
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Advancing QbD in the EU
The ICH guidelines offer pharmaceutical manufacturers the option of taking the "minimal" or traditional approach to quality assurance or an "enhanced" structured approach, which involves concepts like…
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Regulatory Challenges in the QbD Paradigm
The underlying principles of science- and risk-based process and product development and commercialization are also reflected in the contents of the quality guidelines ICH Q8 Pharmaceutical Developmen…
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Eliminating Residual Impurities Starts with a Strategic Plan
…ubstances and how the suitability of any method should be addressed within the guidances outlined in ICH Q2 (R1) (2). European Pharmacopoeia monograph (3) and United States Pharmacopeia General Chap…
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Establishing Acceptance Criteria for Analytical Methods
This logic is essentially laid out in two guidance documents: International Council for Harmonization (ICH) Q6B Specifications and ICH Q9 Quality Risk Management (2).
Clearly defined method accept…