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SOP Guide for Pharma

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SOPs for Analytical Method Development

SOP for Analytical Method Development Method Development Phase III: Validation

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The purpose of this SOP is to outline the procedure for conducting Phase III validation during the method development process, aiming to demonstrate that the developed analytical method is suitable for its intended purpose.
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Analytical Method Development

SOP for Analytical Method Development Method Development Phase II: Optimization

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The purpose of this SOP is to outline the procedure for conducting Phase II optimization during the method development process, aiming to refine and improve analytical methods identified in Phase I.
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Analytical Method Development

SOP for Analytical Method Development Method Development Phase I: Screening

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The purpose of this SOP is to outline the procedure for conducting Phase I screening during the method development process, aiming to identify initial method candidates for further optimization.
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Analytical Method Development

SOP for Analytical Method Development Pre-screening Studies

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The purpose of this SOP is to outline the procedure for conducting pre-screening studies to identify potential analytical methods for further development, ensuring efficient use of resources and time.
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Analytical Method Development

SOP for Analytical Method Development Method Selection Criteria

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The purpose of this SOP is to establish criteria for selecting the most appropriate analytical methods during the method development phase, ensuring that methods chosen meet the required standards of accuracy, precision, and robustness.
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Analytical Method Development

SOP for Analytical Method Development Protocol Design

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The purpose of this SOP is to outline the procedure for designing protocols for the development of analytical methods, ensuring systematic planning and documentation of method development activities.
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Analytical Method Development

SOP for Analytical Method Development Feasibility Studies

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The purpose of this SOP is to describe the procedure for conducting feasibility studies as part of the analytical method development process, ensuring that potential methods are evaluated for their practicality and effectiveness.
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Analytical Method Development

SOP for Analytical Method Development Literature Review

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The purpose of this SOP is to describe the procedure for conducting a comprehensive literature review as part of the analytical method development process, ensuring that all relevant scientific and regulatory information is gathered and reviewed.
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Analytical Method Development

SOP for Analytical Method Development Risk Assessment

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The purpose of this SOP is to describe the procedure for conducting a risk assessment for analytical method development, identifying potential risks, and implementing appropriate mitigation strategies.
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Analytical Method Development

SOP for Analytical Method Development Strategy Selection

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The purpose of this SOP is to describe the process for selecting the most appropriate strategy for analytical method development, ensuring that the chosen approach is suitable for the specific analytical needs and complies with regulatory requirements.
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Analytical Method Development

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Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
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