Pharmaceutical compounding (503B) is compounding pharmacies with outsourcing facilities that may manufacture large batches with or without prescriptions to be sold to healthcare facilities for office use only. 503B compounding pharmacies that provide patient-specific medications are held to higher regulatory standards. These facilities must comply with current good manufacturing practices (CGMP).
PE Articles
New Guide for Compounding Pharmacies
In April 2024, ISPE published the ISPE Guide: 503A Compounding - Regulatory Basis and Industry Good…
iSpeak Blog
New ISPE Guide Provides Support for 503A Compounding Community
A recently released guidance document, the ISPE Guide: 503A Compounding – Regulatory Basis and…
Product
Guide: 503A Compounding
Published: April 2024 Pages: 72 Table of Contents Special Pricing for Emerging Economies Following…
Product
Guide: 503B Compounding
Published: August 2023 Pages: 122 Table of Contents Special Pricing for Emerging Economies An ISPE…
Video
503B Compounding Pharmacies: Principles, GMPs and Case Studies Webinar
Complimentary Learning Level: Advanced Session Length: 2 hours In the early 2010s, there were…
Video
503B Compounding Pharmacies: Principles, GMPs and Case Studies
Join us on 6 May 2021 for the FREE live webinar "503B Compounding Pharmacies: Principles, GMPs, and…
Guidance Documents
Compounding (2)
Good Manufacturing Practice (1)
Quality Assurance (1)
Pharmaceutical Job Board
Community Discussions
Community Discussions
Webinars
iSpeak Blog Posts
iSpeak Blog
New ISPE Guide Provides Support for 503A Compounding Community
A recently released guidance document, the ISPE Guide: 503A Compounding – Regulatory Basis and…
Special Initiative Documents
Pharmaceutical Engineering® Magazine
PE Articles
New Guide for Compounding Pharmacies
In April 2024, ISPE published the ISPE Guide: 503A Compounding - Regulatory Basis and Industry Good…
Professional Development Training
Good Engineering Practice (GEP) Training Course
This course considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEP within it, including how GEP relates to and interfaces with GxP. The scope of GEP covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement. GEP provides a foundation required across the pharmaceutical industry that other areas, such as GxP build upon. This course, based on ISPE Good Practice Guide: Good Engineering Practice (Second Edition) also defines and clarifies GEP as an enabling process for Quality Risk Management…
ICH Q7: API Guidelines
The ICH Q7 guideline ensures consistent quality and safety in the production of Active Pharmaceutical Ingredients (APIs) by defining globally recognized Good Manufacturing Practices (GMP) for all stages of API manufacturing.
ICH Q8: QbD in Manufacturing
The ICH Q8 guideline ensures a systematic approach to pharmaceutical development by defining globally recognized Quality by Design (QbD) principles to enhance product quality throughout all stages of development.
ICH Q10: Pharmaceutical Quality System (PQS)
The Pharmaceutical Quality System (PQS), as defined by ICH Q10, ensures product quality and continuous improvement throughout the lifecycle of pharmaceutical products. Overview This fundamental online course introduces the Pharmaceutical Quality System (PQS), which is a framework that ensures product quality meets established standards throughout the lifecycle of pharmaceutical products. It aims for suitable process performance by implementing robust controls for drug development and manufacturing, including quality assurance, risk management, and regulatory compliance. The system identifies…
A GAMP® Guide to Computerized Systems Compliance
Fundamental Principles of Compliance for Computerized Systems: Implementing the GAMP® 5 Guide 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 efficient and effective manner. Course Modules…