Articles should focus on the role and elements of a quality management system and its impact on the overall risk management approach, as well as its implementation in a scientific and pragmatic manner. Case studies could demonstrate the purpose, elements, and implementation of risk management and a quality management system and systems validation.
Digital transformation is reshaping how highly regulated life sciences companies approach validation, offering an alternative to paper-based processes that can slow cycle times and introduce compliance risk. This handbook examines the fundamentals of digital validation, including its role in supporting data integrity, mitigating noncompliance risk, and preparing organizations for audits and...
For aseptically manufactured medicinal products, the sterility test is an essential criterion for batch release. As part of quality control, the test must be linked to the manufacturing process, resulting in the regulatory requirement to integrate it into a Contamination Control Strategy (CCS) in accordance with Annex 1 of the EU GMP Guidelines.
CAPEX projects are crucial to expanding business and defending against an increasingly competitive landscape, but 95% fail to meet initial cost and time projections. Leading consultants such as McKinsey recommend embedding CQV directly into master schedules to protect projections. Our eBook, The CAPEX Validation Playbook, provides functional advice from Kneat’s CQV expert, Amy Wilhite, to...
As artificial intelligence becomes embedded in validation workflows, life sciences organizations face a governance gap that traditional validation frameworks were not designed to close. AI systems introduce non-deterministic outputs, model drift, data dependency risks, and opacity challenges that demand a structured, continuous approach to oversight — not a one-time compliance exercise....
Digital transformation is reshaping how highly regulated life sciences companies approach validation, offering an alternative to paper-based processes that can slow cycle times and introduce compliance risk. This handbook examines the fundamentals of digital validation, including its role in supporting data integrity, mitigating noncompliance risk, and preparing organizations for audits and...
For aseptically manufactured medicinal products, the sterility test is an essential criterion for batch release. As part of quality control, the test must be linked to the manufacturing process, resulting in the regulatory requirement to integrate it into a Contamination Control Strategy (CCS) in accordance with Annex 1 of the EU GMP Guidelines.
CAPEX projects are crucial to expanding business and defending against an increasingly competitive landscape, but 95% fail to meet initial cost and time projections. Leading consultants such as McKinsey recommend embedding CQV directly into master schedules to protect projections. Our eBook, The CAPEX Validation Playbook, provides functional advice from Kneat’s CQV expert, Amy Wilhite, to...
This eBook examines how artificial intelligence is being applied across life sciences quality assurance and validation, from protocol generation and documentation review to anomaly detection, predictive maintenance, audit preparation, and continuous improvement.
As artificial intelligence becomes embedded in validation workflows, life sciences organizations face a governance gap that traditional validation frameworks were not designed to close. AI systems introduce non-deterministic outputs, model drift, data dependency risks, and opacity challenges that demand a structured, continuous approach to oversight — not a one-time compliance exercise....
Total Organic Carbon (TOC) analysis is a fast and straightforward analytical method that effectively detects all organic residues—including active pharmaceutical ingredients, cleaning agents, degradants, and excipients—while requiring simpler method development and delivering quicker results compared to targeted techniques like HPLC. TOC offers flexible deployment options, functioning as...
The new ISPE Guide: Quality Risk Management provides practical direction on applying QRM principles across the full product life cycle.
Unlock the latest insights and trends in validation practices with the 2026 State of Validation report — now in its fifth year. Independently authored by Donncadh J. Nagle, Senior CQV Consultant at Jacobs Engineering and Lecturer at Technological University Dublin, the State of Validation comprises a broad quantitative and qualitative primary market research study, conducted directly with...
In today’s pharmaceutical landscape, speed, compliance, and efficiency are no longer optional—they’re strategic imperatives. Yet for large capital expenditure (CapEx) projects, traditional paper-based commissioning, qualification, and validation (CQV) workflows remain a major bottleneck, consuming time, resources, and patience.
Radiopharmaceuticals account for many lifesaving diagnostic and therapeutic drug products in the market. These drug products, radioligand therapies (RLTs) in particular, represent a relatively novel modality and present multiple, unique challenges to manufacture, release, ship, and administer.
ASTM E2500, issued in 2007, has been the primary standard guide defining what is required to apply quality risk management (QRM) to achieve the qualification of facilities, systems, and equipment in support of validation and process validation. A major update was undertaken in 2024 to better align the guide with current regulatory and industry guidance and current best practice.
Schedule management faces challenges such as unrealistic deadlines, scope creep, resource constraints, and poor communication, often causing delays and cost overruns. Using tools like an interdependency matrix (IDM) with project management software tools like Microsoft Project improves accuracy, visibility, and control.
This article provides guidance on the best practices to adopt when preparing for an audit or inspection, with a particular focus on commissioning and qualification and the points to consider during the development of materials to explain a company’s individual approach to commissioning, qualification, and validation maintenance.
This article presents a model for promoting data quality of real-world data and evidence (RWD/RWE) and GxP processes with references to ISO 8000 for data quality management, making it a common language between regulated and nonregulated organizations.
With nearly 2,000 drugs currently in shortage across the UK—a staggering increase from 1,608 just one year prior—the pharmaceutical industry faces an unprecedented crisis that demands immediate attention.
The International Council for Harmonisation (ICH) Q2(R2) and Q14 guidelines, finalized in late 2023, outline strategies for analytical procedure development, validation, and lifecycle management. As global implementation progresses, ISPE’s PQLI® Analytical Method Strategy Team surveyed industry stakeholders in mid-2024 to assess readiness, identify opportunities, and highlight areas...
The pharmaceutical industry is under increasing pressure to develop new therapies at a faster pace, while lowering drug costs, enhancing quality, and maintaining safety and a robust supply chain.
The move to digital transformation represents a true paradigm shift in manufacturing, enabling organizations to leverage advanced technologies such as the Industrial Internet of Things (IIoT), cloud computing, and artificial intelligence (AI) to ensure compliance and secure a competitive advantage. This article presents a working definition of digital transformation, the components involved in...
The ISPE Commissioning & Qualification (C&Q) Community of Practice (CoP) conducted a survey in 2023 on the adoption of integrated C&Q, specifically on the use of paperless digital systems for planning, executing, and reporting C&Q activities. The survey revealed that 74% of respondents planned to use Digital Validation Tools (DVTs) for C&Q by 2024.
This article describes the numerous activities in the commercial quality control (QC) network that aim to replace in vivo assays with alternative methods in the course of production and release.1
The pharmaceutical landscape is rapidly evolving, and cell and gene therapies (C>) are at the forefront of this transformation. These therapies are revolutionizing how we approach patient care, particularly in the realm of personalized medicine. However, this innovation has also introduced challenges, especially when establishing new manufacturing facilities.
On 25 August 2023, the long-awaited revision to Annex 1 became effective, introducing significant regulatory changes, including the requirement of a documented contamination control strategy (CCS). During a workshop at the 2023 ISPE Annual Meeting & Expo, 11 teams of attendees were presented with a risk-based methodology to develop and evaluate CCS elements focused on extrinsic...
In the dynamic and highly regulated world of biopharmaceutical manufacturing, maintaining and ensuring quality is a critical success factor. An effective quality risk management (QRM) system is a key component in the overall quality management infrastructure of biopharmaceutical organizations. It offers a structured, scientific, and risk-based approach to decision-making, addressing potential...
As the pharma industry moves to an ambitious Validation 4.0 paradigm, computerized systems play a pivotal role in enabling the rapid transition. Innovation and agility in computerized system validation (CSV) received a strong push in the second half of 2022 with the publication of the FDA draft guidance on “Computer Software Assurance for Production and Quality System Software”
The world is beginning to grasp the huge challenge of achieving net-zero carbon emissions, or carbon neutrality, by 2050. Many countries have committed to achieving this ambitious goal. As a major global industry, the pharmaceutical sector has a significant role to play. For thermal energy–intensive industries, such as pharmaceutical manufacturing, the long-term future options to maintain...
Calibration plays a critical role in ensuring a measurement instrument’s accuracy—especially if the instrument has a direct impact on product quality and patient safety. However, the calibration process is a complex system, and the traditional analytical approach for planning this process is often not sufficient to improve service performance. Using a digital simulation model as a...
Process capability is a fundamental concept for manufacturers. Pharmaceutical, biopharmaceutical, and medical device manufacturers leverage capability analysis along with other statistical quality control (SQC) techniques to enable timely supply of quality medicine to patients.
Understanding and managing risks to continuous manufacturing (CM) technology is central to any decision to greenlight CM in a production-ready environment. Applying a systemwide risk management (SRM) approach to manufacturing is essential to ensuring manufacturing projects are vetted in a comprehensive and consistent manner.
Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification technology, with investment expected to rise in the coming years and the focus shifting toward biologics. This article provides a review on the current state of CM implementation, offers insights into life cycle management and regulatory aspects, and explains how a data- and knowledge-centric approach...
When working with the common technical dossier (CTD), the structure of Module 2 “follows the scope and outline of the Body of Data in Module 3,”
Topical drug products and cosmetics are often manufactured in the same facility under a unified quality standard that supports the topical drug products’ performance and label claims. Cleaning is an important component of a manufacturing process, and the process life-cycle approach should be followed for cleaning validation.
An interview with Shin Kawamata of Japan’s Foundation for Biomedical Research and Innovation (FBRI) highlights exciting work to move cell therapy toward reliable and scalable commercialization.
Before the COVID-19 pandemic, it was unthinkable for a system integrator to suggest remotely conducting an acceptance test for an automation project. This article shows how automation engineers and client validation personnel were successful in navigating COVID-19 restrictions and overcoming previously held preconceptions about remote testing to meet end-user and regulatory requirements....
Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Incorporating concepts and tools from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline, combined with structured content and data management (SCDM) and a cloud-based data exchange...
Steam is the most powerful and effective thermal energy transfer fluid, and its use continues to grow in process industries around the world. However, there is very little written about the commissioning and qualification of pharmaceutical pure steam systems in GMP regulations or regulatory guidance. This article provides the background and science behind the steam quality tests and proposes a...
Global commissioning, qualification, and validation (CQV) project delivery has in recent years been required to push the boundaries on delivery methodologies and techniques to ensure sufficient production capacity is available to meet ever-expanding patient needs. This article focuses on lessons captured in the execution and resource management of large-scale global CQV projects in an...
Good data are a characteristic of good science. Quality data are arguably more important today than ever before and are considered by many to be a corporate asset because they are used to develop products and processes, control our manufacturing processes, and improve products and processes when needed.
Recently, recalls of angiotensin receptor antagonists, particularly valsartan, and warning alerts about N-nitrosodimethylamine (NDMA) impurities in drug substances such as ranitidine and metformin have demonstrated the urgent need for manufacturers and regulators to control impurities throughout the product life cycle to ensure patient safety.
Executives at manufacturing companies of all sizes need to make decisions about where to invest to maintain and grow their businesses. Investments in manufacturing execution system (MES) applications may reduce costs and increase revenues, but they also might compete with other investment priorities, such as marketing campaigns and capital equipment upgrades. This article offers guidance for...
A temperature sensor in a medical autoclave is typically calibrated once a year. If the sensor proves to be inaccurate, all batches produced since the last calibration must be evaluated. Endress+Hauser has developed a self-calibrating sensor that automatically verifies its accuracy during each sterilization batch. This article describes a case study at the Merck Healthcare KGaA sterile...
Process analytical technology (PAT) is perceived as the main enabler for a robust control strategy with continuous manufacturing (CM) because process analytical technology can aid in implementing continuous manufacturing throughout the entire life cycle. This article discusses quality and regulatory hurdles in the life cycle of a process analytical technology application—including model...
Existing risk-based approaches to computerized system compliance and validation as outlined in GAMP® 5
Historically, the pharmaceutical industry’s focus has been on the lyophilization process and equipment, but discussion about calibration of process monitoring and control instrumentation has been quite limited. Recently, focused attention has been given to control and monitoring instrumentation for lyophilization.
Continued process verification (CPV) as defined in the US FDA process validation guideline
For over two decades, the ISPE Barrier Isolator Survey has gathered meaningful data on the applications of barrier technology and been a resource for the fill-finish pharmaceutical industry community. This article provides context for the latest survey, the first in several years, and presents its key results, which were first shared at the
As the old saying goes, “Time is money.” In today’s industrialized world, this adage is profoundly true. Manufacturers can no longer afford to overlook operational excellence. A new production philosophy called “Lean manufacturing” has been developed to save as much time as possible during manufacturing processes. In some industries, such as the automotive sector, Lean has almost been...
Applying emerging technologies can lead to more robust and flexible manufacturing processes that in turn can help the pharmaceutical industry respond to drug shortages, reduce interruptions in production and delivery of medicines, ensure consistent clinical performance of products, and achieve other benefits. Although some may believe that regulators are averse to the use of emerging...
As the pharmaceutical industry balances demands for small-batch and blockbuster products and encounters new regulations, there is a need for efficient and safe production technologies that can meet stringent quality and safety requirements for the aseptic filling of drugs. Looking forward, manufacturers should anticipate future format, packaging, and filling needs, and seek technologies with...
According to US Pharmacopeia (USP) Chapter <790>, “all parenteral products should be essentially free from any visible particles.”
Analytical target profile criteria for judging the quality of results generated by analytical methods are framed in an optimization paradigm by illustrating the ATP criteria as a loss function. In the case where specifications are based on quality arguments and process capability, a probability-defined loss function is useful for providing a direct measurement of risk for making incorrect...
