The Ultimate Resource for Pharmaceutical SOPs and Best Practices
This SOP defines the procedure for conducting forced degradation studies to establish the stability-indicating capability of an analytical method. It ensures that degradation pathways are understood and that the method can accurately quantify the active ingredient in the presence of degradants, as per ICH Q1A and Q2(R1).
Click to read the full article.
This SOP describes the systematic procedure for developing and confirming the stability-indicating nature of analytical methods used for pharmaceutical substances and products. The objective is to demonstrate that the method can accurately separate and quantify active ingredients in the presence of degradation products, as required by ICH Q1A(R2), Q2(R1), and GMP expectations.
Click to read the full article.
The purpose of this SOP is to define the procedure for the preparation, review, approval, and archival of the Method Development Protocol (MDP). The protocol provides a pre-defined framework for conducting method development studies in compliance with ICH Q2(R1), Q8, WHO TRS, and GMP requirements.
Click to read the full article.
The purpose of this SOP is to define a standardized format and procedure for preparing a Method Development Report (MDR) that captures all experimental data, observations, and decisions made during the analytical method development process. The report ensures traceability, scientific justification, and regulatory compliance as per ICH Q2(R1) and GMP expectations.
Click to read the full article.
This SOP defines the procedure for documenting the Analytical Target Profile (ATP), which serves as the foundational guideline for developing and validating analytical methods. The ATP ensures that analytical methods meet their intended purpose with respect to accuracy, precision, specificity, and other performance attributes aligned with ICH Q8 and Q14 expectations.
Click to read the full article.
This SOP outlines the principles and execution strategy of a Quality by Design (QbD) approach in analytical method development. It aims to ensure method robustness, regulatory compliance, and scientific justification through a systematic, risk-based, and knowledge-driven methodology as described in ICH Q8, Q9, Q10, and Q14.
Click to read the full article.
This SOP provides a systematic approach for the application of Design of Experiments (DoE) in analytical method development. It aims to identify critical method parameters (CMPs), understand their impact on method performance, and facilitate robust, reproducible, and scientifically justified method design in line with ICH Q8, Q9, and Q14 guidelines.
Click to read the full article.
This SOP defines the process for developing an analytical control strategy during the lifecycle of analytical method development. The strategy ensures control over method parameters and analytical performance to deliver reliable, reproducible, and regulatory-compliant results in line with ICH Q8, Q10, and Q14.
Click to read the full article.
This SOP defines the approach for managing the lifecycle of analytical methods, encompassing development, validation, routine use, performance monitoring, and retirement. The goal is to ensure method robustness, compliance with current regulatory expectations (ICH Q14/Q10), and consistent performance throughout the method’s operational life.
Click to read the full article.
The purpose of this SOP is to outline the systematic procedure for drafting analytical specifications for raw materials, intermediates, drug substances, and finished pharmaceutical products. It ensures specifications are scientifically justified, aligned with regulatory requirements (ICH Q6A/B), and support product quality throughout its lifecycle.
Click to read the full article.