Regulatory

Leadership in regulation and quality affairs associated with ISPE core concerns and priorities

ISPE strives to facilitate industry wide clarity of new applicable regulations, advising on impacts and resolving towards solutions, seeking harmonization of regulatory expectations where desired and possible.

ISPE engages with all levels of regulators in the development and presentation of our education, training, document development, and interpretation to ensure that our offerings are cutting-edge and focused on clarifying issues and solving problems of importance to industry.

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Pharmaceutical Engineering Magazine Articles

New EU AI Regulation and GAMP® 5

This article describes how ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems…

Risk Management for Avoidance of Drug Shortages

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

Enabling Global Pharma Innovation: Delivering for Patients

ISPE has launched an important new initiative, “Enabling Global Pharma Innovation: Delivering for…

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…

Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing

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

A New Regulatory Approach to Drive Sustainable Medicines

To enable changes across the pharmaceutical industry, sustainability should be included alongside…

ISPE Briefs: New Guide Helps Maintain and Establish PPPQMS

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

2022 ISPE Aseptic Conference: Regulatory Panel Discusses ATMPs, Data Integrity, Inspections, & More

The 2022 ISPE Aseptic Conference Regulatory Panel session on 15 March was as always one of the…

Regulatory Landscape for Raw Materials: CMC Considerations

A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients…

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

Postapproval change management of pharmaceuticals is an essential part of life-cycle management but…

Is a Globally Harmonized Quality Overall Summary Possible?

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human…

Webinars Related to Regulatory

Concept and Discussion Papers

1 September 2023

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

QA QbD Regulatory

1 January 2022

Emerging Leaders has grown from an initiative for interactions among early-career professionals and…

Regulatory WoF

1 February 2021

Health authorities and regulators are increasingly looking for much higher levels of traceability…

Packaging Supply Chain

1 June 2018

1 Introduction Contemporary communications technologies, particularly those relating to the internet…

1 February 2012

1 Introduction It is current practice to use booklet labels for labelling of Investigational…

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Special Initiatives

Videos Related to Regulatory

iSpeak Blog Posts Related to Regulatory

Featured Conferences

Expert Xchanges

Training Courses Related To Regulatory

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

Pre-Approval Inspection Readiness Training Course

This new training course on the elements necessary to ensure readiness for pre-approval inspections provides strategy and tactics towards preparation than can be customized to individual organization requirements. View Course

Implementation of ICH Q12 Guideline

Delivery Mode: Webinar ISPE Team Assists Training Health Canada with Implementation of ICH Q12 Guideline, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Regulatory Background International Council for Harmonisation’s (ICH) guideline entitled, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management” (ICH Q12) provides a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. Implementation of ICH’s… View Course

Biopharmaceuticals: CMC Aspects

This instructor led course is an advanced level course on Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutical development. The purpose of this course is to provide an advanced understanding of the CMC considerations of biopharmaceuticals from development to commercialization. An emphasis will be placed on using Quality by Design principles to develop, manufacture and guide the product lifecycle. Lastly, we will examine biosimilars and regulatory factors that affect product development and the product lifecycle and drug costs. View Course

Requirements for Computerized Systems Validation and Compliance

This online course describes regulatory requirements and expectations regarding the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices. It does not cover the detailed requirements of 21 CFR Part 11, except for the requirement that systems be validated. Even though it draws upon medical device guidance, it is not intended to cover all the requirements of producing software that subsequently becomes part of a medical device. View Course

Basic Principles of Computerized Systems Compliance

Basic Principles of Computerized Systems Compliance: Applying the GAMP5® Guide: A Risk-Based Approach to Compliant GxP Computerized Systems This fundamental online course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an… View Course

Critical Utility GMP Compliance

This course is focused on how to be compliant in the design, operation & qualification of critical utilities and how to prove it. It comprises four modules including interactive case studies from real experience. This helps the participants to experience live discussions on compliance topics. The content is primarily based on the new ISPE Good Practice Guide “Critical Utilities GMP Compliance”. View Course

Commissioning and Qualification Training Course

Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500. View Course

Process Validation Training Course

This training course is relevant to individuals working throughout the pharmaceutical product lifecycle in development, manufacturing, quality, and many other roles involved in validation of products and processes. It will help you integrate and link the science and risk-based lifecycle approach for Process Validation to your overall Pharmaceutical Quality System. View Course

GMP Fundamentals for the Pharmaceutical Industry

This course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information about both European regulators and the FDA, how the various agencies enforce GMP requirements, and what to expect during a routine GMP inspection. They will examine and discuss the process of a regulatory inspection and gain valuable insight into the compliance auditing process. View Course

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Regulatory

Regulatory

Leadership in regulation and quality affairs associated with ISPE core concerns and priorities

Related Guidance Documents

Active Pharmaceutical Ingredients (2)

Advanced Therapy Medicinal Products (1)

Biotechnology (3)

Critical Utilities (6)

Drug Shortages (2)

Good Manufacturing Practice (1)

Investigational Products (3)

Knowledge Management (2)

Lifecycle Management (1)

Manufacturing Operations (4)

Microbiological & Viral Contamination Control (8)

Packaging (1)

Quality Assurance (2)

Quality Control (1)

Regulatory (5)

Sterile Products (1)

Supply Chain Management (2)

Community Discussions

Community Discussions

Pharmaceutical Engineering Magazine Articles

New EU AI Regulation and GAMP® 5

Risk Management for Avoidance of Drug Shortages

Enabling Global Pharma Innovation: Delivering for Patients

Agile, Data-Driven Life Cycle Management for Continuous Manufacturing

ICH Q13 and What Is Next for Continuous Manufacturing

Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing

A New Regulatory Approach to Drive Sustainable Medicines

ISPE Briefs: New Guide Helps Maintain and Establish PPPQMS

2022 ISPE Aseptic Conference: Regulatory Panel Discusses ATMPs, Data Integrity, Inspections, & More

Regulatory Landscape for Raw Materials: CMC Considerations

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

Is a Globally Harmonized Quality Overall Summary Possible?

Webinars Related to Regulatory

Patient-Centric Specifications from an Industry & Regulatory Perspective

Advance Biopharma Tech Transfer Using Process Modeling & Simulation Webinar

Annex 1: Revision 2020 and ISPE Commenting

Challenges & Successes of ICH Q12 Related Submissions

GAMP® 5, FDA CSA, and the Future of Computer Systems Validation Webinar

Regulatory Opportunities & Challenges for Portable Manufacturing

Regulatory Responses to 503B Compounding Pharmacies

Opportunities for Drug Shortage Prevention – Industry and Regulator Views

Analytical Instrument Qualification – A Continuum of Requirements, from USP <1058> to GAMP® 5 Webinar

Bridging the Communication Gap Between Critical Utilities & Regulators: NEW ISPE Critical Utilities GMP Compliance Guide

Demystifying Your Questions on Revised Commissioning & Qualification ISPE Baseline Guide Vol. 5 Webinar

Concept and Discussion Papers

Special Initiatives

Videos Related to Regulatory

Patient-Centric Specifications from an Industry & Regulatory Perspective

2023 ISPE Biotechnology Conference Highlights

Advance Biopharma Tech Transfer Using Process Modeling & Simulation Webinar

Annex 1: Revision 2020 and ISPE Commenting

Challenges & Successes of ICH Q12 Related Submissions

GAMP® 5, FDA CSA, and the Future of Computer Systems Validation Webinar

Regulatory Opportunities & Challenges for Portable Manufacturing

ISPE Expert Xchange: Regulatory Summit on ICH Q9 Revision

Regulatory Responses to 503B Compounding Pharmacies

Opportunities for Drug Shortage Prevention – Industry and Regulator Views

Search 2021 ISPE Pharma 4.0™ and Annex 1 Conference

Changes That COVID-19 Forced in the Way Inspections and Reviews Are Handled by Regulatory Agencies

iSpeak Blog Posts Related to Regulatory

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

Regulatory, Compliance and Quality Challenges, Learnings, and Future Opportunities

ISPE GAMP SIG MES Planning to Move the Industry Forward

EMA on International Cooperation, Harmonization, and Reliance in GMP

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

EMA Executive Director Speaks on the Value of Adaptation, Trust, & Collaboration

ICH Q9 (R1): The Next Frontier

Regulators Discuss Harmonization & Innovation, Regulatory Agility & Speed, & Workforce Skills

Paperless Validation Systems: Truly Paperless?

Asia-Pacific Regulatory & Industry Views on Drug Shortage Prevention

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

Best Practices for “True Copy Verification” with Paperless Validation Systems

Featured Conferences

2023 ISPE Annual Meeting & Expo

2023 ISPE Pharma 4.0™ and Annex 1 Conference

2024 ISPE Aseptic Conference