Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Quality Control01:05

Quality Control

369
Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
369
Quality Assurance01:19

Quality Assurance

257
Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
257
Data Validation01:15

Data Validation

287
Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
287
Development of Analytical Methods01:21

Development of Analytical Methods

796
An analytical methodology can be divided into four sequential steps: technique, method, procedure, and protocol. A technique is a scientific principle that rationalizes a specific phenomenon through chemical measurements. Adapting a technique for analyzing a sample of interest is termed a method. The procedure outlines the directions for performing the analysis via an analytical method. The protocol is the detailed guidelines on the procedure, which should be strictly followed to obtain the...
796
Introduction to Statistical Process Control01:15

Introduction to Statistical Process Control

313
Statistical Process Control (SPC) is a method used to monitor and control quality within processes, particularly in manufacturing and service delivery, by employing statistical methods. SPC aims to distinguish between natural (common cause) variation and variation due to specific changes or events (special cause), allowing for timely improvements and sustained quality. The control chart, a pivotal tool in SPC, visually displays data over time alongside a central line of upper and lower control...
313
Qualitative Analysis01:10

Qualitative Analysis

745
Qualitative analysis is the process of identifying elements, ions, or compounds in an unknown sample. It is the first and most fundamental type of analysis based on the hierarchy of analytical goals. This hierarchy is significant as it provides a structured approach to scientific research, with qualitative analysis serving as the initial step, providing essential information before moving on to quantitative or other forms of analysis.
There are two main approaches to qualitative analysis:...
745

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Leveraging analytical and bioprocess platforms for biological product development and commercialization - A meeting report.

Biologicals : journal of the International Association of Biological Standardization·2026
Same author

Discoloration source and control of a biotechnological drug product manufactured using a high titer production process.

Journal of pharmaceutical sciences·2025
Same author

Application of DOE to ELISA Robustness and Ruggedness Assessment.

The AAPS journal·2025
Same author

How to accelerate the supply of vaccines to all populations worldwide? Part III: Reflections after the pandemic.

Vaccine·2025
Same author

A vision for patient-centric specifications for biologicals.

Biologicals : journal of the International Association of Biological Standardization·2024
Same author

Case Studies on Changes and Proposed Process Development Approaches Reflecting Applicability of PDA <i>Technical Report No. 89: Strategies for Vaccine Development and Lifecycle Management</i>.

PDA journal of pharmaceutical science and technology·2024

Related Experiment Video

Updated: Oct 3, 2025

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

3.7K

Analytical Quality by Design, Life Cycle Management, and Method Control.

Thorsten Verch1,2, Cristiana Campa3, Cyrille C Chéry4

  • 1Merck & Co., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, United States of America. Thorsten_verch@merck.com.

The AAPS Journal
|February 12, 2022
PubMed
Summary

Analytical Quality by Design (AQbD) offers a systematic framework for robust analytical methods in biopharmaceutical research and manufacturing. This approach ensures continuous data quality, risk management, and life cycle control, aligning with ICH Q14 guidelines.

Keywords:
AQbDAnalytical target profile (ATP)Life cycle managementMethod validationQuality by design (QbD)

More Related Videos

Design and Construction of an Urban Runoff Research Facility
13:48

Design and Construction of an Urban Runoff Research Facility

Published on: August 8, 2014

13.2K
The Cultivation, Growth, and Viability of Lactic Acid Bacteria: A Quality Control Perspective
04:40

The Cultivation, Growth, and Viability of Lactic Acid Bacteria: A Quality Control Perspective

Published on: June 16, 2022

8.5K

Related Experiment Videos

Last Updated: Oct 3, 2025

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

3.7K
Design and Construction of an Urban Runoff Research Facility
13:48

Design and Construction of an Urban Runoff Research Facility

Published on: August 8, 2014

13.2K
The Cultivation, Growth, and Viability of Lactic Acid Bacteria: A Quality Control Perspective
04:40

The Cultivation, Growth, and Viability of Lactic Acid Bacteria: A Quality Control Perspective

Published on: June 16, 2022

8.5K

Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Biotechnology

Background:

  • Analytical methods are crucial for biopharmaceutical and vaccine R&D and manufacturing.
  • Ensuring continuous data quality for decision-making and risk management is essential.
  • Traditional methods face challenges in robust validation and life cycle management.

Purpose of the Study:

  • To provide context and implementation details for Analytical Quality by Design (AQbD) in relation to ICH Q14.
  • To illustrate the AQbD workflow, its advantages over traditional methods, and pathways for real-time verification.
  • To discuss implementation challenges and regulatory strategies for AQbD.

Main Methods:

  • The study expands on existing AQbD concepts, referencing ICH Q8, Q9, USP 1220, and ICH Q14.
  • Illustrative examples are used to describe the AQbD workflow and its integration with regulatory guidelines.
  • Discussion includes comparisons with traditional analytical approaches and real-time verification strategies.

Main Results:

  • AQbD provides a systematic framework for developing and managing analytical methods throughout their lifecycle.
  • Implementation of AQbD can lead to continuously validated, robust assays.
  • The paper outlines potential pathways for ongoing, real-time verification of analytical methods.

Conclusions:

  • AQbD is a valuable framework for enhancing analytical method quality and reliability in the biopharmaceutical industry.
  • Alignment with ICH Q14 facilitates the implementation and regulatory acceptance of AQbD.
  • Addressing implementation challenges and regulatory strategies is key to successful AQbD adoption.