Quality

Content focuses on the role and elements of a quality management system, its impact on the overall risk management approach, and its implementation scientifically and pragmatically. Case studies could demonstrate risk management's purpose, elements, and implementation, a quality management system, and systems validation.

Pharmaceutical Engineering Magazine Articles

Air Speed Qualification: At Working Position or Working Level?

The new European Commission GMP Annex 1 “Manufacture of Sterile Medicinal Products” and the…

Risk Management for Avoidance of Drug Shortages

Shortages of essential medicines around the world have been an ongoing concern for patients…

A Systemwide Approach to Managing the Risks of Continuous Manufacturing

Understanding and managing risks to continuous manufacturing (CM) technology is central to any…

Agile, Data-Driven Life Cycle Management for Continuous Manufacturing

Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification…

ICH Q13 and What Is Next for Continuous Manufacturing

The creation of a new ICH guidance document, Q13,International Council for Harmonisation of…

Enhanced Intervention Detection in Aseptic Fill Using AI/ML

We will show how continuous, real-time capturing of data with immediate data analysis by an ML…

CMC Requirements for New Drug Registration in Latin America

The global pandemic has demonstrated that now, more than ever, we need to work toward a global…

A Proposal for a Comprehensive Quality Overall Summary

When working with the common technical dossier (CTD), the structure of Module 2 “follows the scope…

Contamination Trends & Proposed Solutions

Contamination is one of the top reasons for medicinal productUK Medicines and Healthcare Products…

ISPE Briefs: New Guide Promotes Cultural Excellence

Cultural excellence is the expressed and implied ways in which an organization operates. Excellence…

Life-Cycle Approach to Cleaning Topical Drug Products

Topical drug products and cosmetics are often manufactured in the same facility under a unified…

ISPE Briefs: New Guide Helps Maintain and Establish PPPQMS

ISPE’s new Advancing Pharmaceutical Quality (APQ) Guide: Process Performance and Product Quality…

Webinars Related to Quality

Concept and Discussion Papers

1 September 2023

Regulatory Trends & Quality Initiatives - Shortages of essential medicines around the world have…

QA QbD Regulatory

1 July 2023

Continuous manufacturing (CM) challenged regulators’ expectations and regulatory frameworks. This…

Adv Manuf Regulatory

1 May 2023

North Carolina’s Research Triangle is the largest of its kind in the US. Thanks to years of effort…

WoF

1 July 2022

ISPE held an Expert Xchange on 18 January 2022 that included presentations and interactive exercises…

KM Project Mgmt QA

21 February 2020

In August 2017, ISPE published the Discussion Paper “Overview of Packaging Validation for Drug…

Lifcyc Mgmt OSD Validation

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Special Initiatives

Videos Related to Quality

iSpeak Blog Posts Related to Quality

Expert Xchanges

Featured Conferences

Training Courses Related to Quality

GMP Fundamentals: Eleven-Part Bundle Series

Obtain a 10% Savings by Purchasing All Eleven Courses Overview ISPE is presenting an eleven-part series that will focus on the fundamentals of good manufacturing practices (GMPs). The series provides an overview of the regulations pertaining to GMPs and covers topics such as: manufacturing controls, product distribution, plant hygiene, documentation practices, buildings & facilities, organizational structure, and more. This offering gives users access to all eleven modules of the series and is intended to introduce GMPs for the new pharmaceutical employee or to provide an annual refresher for… View Course

Hands-On Aseptic Processing & Annex 1 & ATMP Manufacturing Training

To meet the challenges of the new Annex 1 guidance while enhancing industry efforts to develop, manufacture, and reliably deliver quality medicines to patients, ISPE is conducting a 4-day interactive training event in a unique setting, the European Aseptic and Sterile Environment (EASE) Facility in Strasbourg, France. This training provides hands-on opportunities to interact with equipment in a facility built for training pharmaceutical industry workers. During the training sessions, attendees will have the opportunity to conduct aseptic processing steps as well as ATMP manufacturing exercises… View Course

CAPA / RCA / Investigations Training Course

Coming Soon 2024 - CAPA and Continuous Improvement using Process Performance & Product Quality Monitoring (PPPQMS), are elements of the Pharmaceutical Quality System (PQS), supported by ICH Q10. By practicing effective CAPA and PPPQMS a Pharmaceutical Quality System can realize Quality Management Maturity. View Course

GMP Fundamentals: Holding & Distribution

In this course, you will learn the requirements for storing, handling, and distributing finished products to ensure they are stored properly and not contaminated or altered during transport. For a limited time, registration fees are waived for this course. Interactive Course: What to Expect CEUs are provided once you achieve an 80% passing grade and complete the evaluation. Buy Now Return to Online Learning View Course

GMP Fundamentals: Packaging & Labeling Control

In this course, you will learn how to ensure the safety and quality of pharmaceutical products using fundamental principles and best practices. During this course, you will learn about the FDA's pharmaceutical packaging and labeling guidelines. You will gain an understanding of the basics of packaging and labeling operations, including production and inspection processes, documentation, and record-keeping. Interactive Course: What to Expect CEUs are provided once you achieve an 80% passing grade and complete the evaluation. Buy Now Return to Online Learning View Course

GMP Fundamentals: Production & Process Controls

This course offers an overview of Good Manufacturing Practices (GMP) for medical product production and process control. You will learn about GMP compliance, product design and development, process validation, control systems, and quality control procedures. Regulatory requirements, including FDA and international standards, will be covered. Upon completion, you will understand the fundamental principles and practices of GMP in medical product production. Interactive Course: What to Expect CEUs are provided once you achieve an 80% passing grade and complete the evaluation. Buy Now Return to… View Course

GMP Fundamentals: Control of Excipients, Components and Drug Product Containers/Closures

In this course, you will learn about the fundamentals and importance of GMP control in the pharmaceutical industry. Good Manufacturing Practices (GMP), is critical for ensuring the quality, safety, and efficacy of pharmaceutical products. This includes controlling excipients, components, and drug product containers/closures to meet specific standards and requirements, reducing the risk of contamination, degradation, or incorrect formulation. You will gain a deeper understanding of the role of GMP control in maintaining the integrity of the supply chain, and how following GMP guidelines helps… View Course

GMP Fundamentals: Buildings and Facilities

A “GMP Facility” is a building that is used in the production of pharmaceutical and medical device products. The proper design, layout, function and control of such facilities is essential in the manufacture of pure, safe and effective pharmaceutical products. In this course, learners will focus on understanding the building layout, safety, cleanroom conditions, as well as facility sanitation and ventilation of both production and support areas. In this On Demand course (part 4 of 11), you will learn the elements of GMP Buildings & Facilities, as required by regulation. Interactive Course… View Course

GMP Fundamentals: Equipment

GMP equipment is used in the production of pharmaceutical and medical device products. The proper design, function, qualification and control of such equipment is essential in the manufacture of pure, safe and effective pharmaceutical products. In this course learners will understand equipment design, size and location, cleaning & maintenance as well as the qualifications of GMP equipment. In this On Demand course (part 5 of 11), you will learn the elements of GMP equipment, as required by regulation. Interactive Course: What to Expect CEUs are provided once you achieve an 80% passing grade… View Course

GAMP® Data Integrity 21 CFR Part 11, 2-Day Training Course

The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result, industry guidance and enforcement strategies are evolving. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical, biotech, and medical device business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This… View Course

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Quality

Quality

Related Guidance Documents

Commissioning & Qualification (5)

Compounding (1)

Data Integrity (15)

Drug Shortages (1)

GAMP® (16)

Good Manufacturing Practice (1)

Knowledge Management (6)

Lifecycle Management (3)

Manufacturing Operations (1)

Microbiological & Viral Contamination Control (2)

Pharma 4.0™ (1)

Process Analytical Technology (4)

Project Management (1)

Quality Assurance (8)

Quality Control (1)

Quality by Design (3)

Regulatory (2)

Sustainable Facilities, HVAC, & Controlled Environments (1)

Validation (14)

Community Discussions

Community Discussions

Pharmaceutical Engineering Magazine Articles

Air Speed Qualification: At Working Position or Working Level?

Risk Management for Avoidance of Drug Shortages

A Systemwide Approach to Managing the Risks of Continuous Manufacturing

Agile, Data-Driven Life Cycle Management for Continuous Manufacturing

ICH Q13 and What Is Next for Continuous Manufacturing

Enhanced Intervention Detection in Aseptic Fill Using AI/ML

CMC Requirements for New Drug Registration in Latin America

A Proposal for a Comprehensive Quality Overall Summary

Contamination Trends & Proposed Solutions

ISPE Briefs: New Guide Promotes Cultural Excellence

Life-Cycle Approach to Cleaning Topical Drug Products

ISPE Briefs: New Guide Helps Maintain and Establish PPPQMS

Webinars Related to Quality

Unique Glass Primary Containers Identification In Pharmaceutical Fill & Finish Operations: Best Practice for Achieving Product Traceability, Process Visibility & Quality

Patient-Centric Specifications from an Industry & Regulatory Perspective

Data Integrity in Pharma Industry: Adhere to Compliant Documentation for Your Plant Operations

ISPE Process Analytical Technology & Lifecycle Control Strategy Townhall

Advancing Pharmaceutical Quality, Change Management

Increasing Efficiency through Management of Decontamination Cycles

Making the Leap to Paperless Validation

Process Validation: Stage 1 - Process Design Webinar

Process Validation: Stage 2 - Process Performance Qualification or Process Validation Webinar

Process Validation: Stage 3 - Continued Process Verification or Ongoing Process Verification Webinar

Cold Chain Management – How to Move Frozen Substances Across the Globe in a Safe & Simple Manner

Points to Consider When Transitioning to Real Time Testing (RTT) of Water Systems

How Continuous Monitoring & Building Management Systems Support Monitoring, Compliance, & Control

Next-Generation Life Sciences Facilities: Cybersecurity Strategy for Digital Economy Embracing Sustainability

Quality Management Maturity: ISPE Advancing Pharmaceutical Quality Program in Action!

Concept and Discussion Papers

Special Initiatives

Videos Related to Quality

Unique Glass Primary Containers Identification In Pharmaceutical Fill & Finish Operations: Best Practice for Achieving Product Traceability, Process Visibility & Quality

Patient-Centric Specifications from an Industry & Regulatory Perspective

2023 ISPE Biotechnology Conference Highlights

Data Integrity in Pharma Industry: Adhere to Compliant Documentation for Your Plant Operations

ISPE Hands-on Pharmaceutical Training

2023 ISPE Europe Annual Conference: Digital Transformation and Pharma 4.0™, Annex 1, and GAMP 5®

ISPE Process Analytical Technology & Lifecycle Control Strategy Townhall

Advancing Pharmaceutical Quality, Change Management

Increasing Efficiency through Management of Decontamination Cycles

Making the Leap to Paperless Validation

Process Validation: Stage 1 - Process Design Webinar

Process Validation: Stage 2 - Process Performance Qualification or Process Validation Webinar

iSpeak Blog Posts Related to Quality

Annex 1 in Force! Join the First Discussion after the 25 August Effective Date

EMA on International Cooperation, Harmonization, and Reliance in GMP

Annex 1, ATMPs and Pharma 4.0 - How Do They Fit Together

ICH Q9 (R1): The Next Frontier

Assessing Digital Transformation: A Closer Look at the Smart Industry Readiness Index Maximizing the Benefits of Siri for Life Sciences Manufacturing Plants

Insider’s Guide to Manufacturing, QC, and Operational Excellence

Paperless Validation Systems: Truly Paperless?

The Journey to Quality Management Maturity: ISPE European Conference keynote and ISPE APQ Program

ISPE QC/Analytical Community of Practice Established

Mastering the Process: Key Strategies for Commissioning to Qualification in Project Management

How Process Simulation Enhances Tech Transfer and Regulatory Submissions in the Biopharma Product Lifecycle

How Continuous Monitoring & Building Management Systems Support Monitoring, Compliance, & Control