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Global News
14 June, 2019Sites and Eats of Boston - 2019 ISPE Biopharmaceutical Manufacturing Conference
Boston, home to Fenway Park and the ever-famous Boston Red Sox, w...Boston, home to Fenway Park and the ever-famous Boston Red Sox, will host the 2019 ISPE Biopharmaceutical Manufacturing Conference. The city is known for its historic signific... View All Blog Posts14 June, 2019
13 June, 2019Know Before You Go - 2019 ISPE Biopharmaceutical Manufacturing Conference
Conference Essentials Conference Agenda Travel Tips Registratio...Conference Essentials Conference Agenda Travel Tips Registration and Information Hours Tuesday, 18 June | 0700–1700 Wednesday, 19 June | 0700–1700 Thursday, 20 June | 0700–... View All Blog Posts13 June, 2019
12 June, 2019Direct to Patient: Quality Considerations & Novartis Experience
Discussion: In the introductory blog, “Direct to Patient: The Ba...Discussion: In the introductory blog, “Direct to Patient: The Basics & Quality Considerations”1 a collaborating team of direct to patient (DtP) sponsors, couriers, CROS, and... View All Blog Posts12 June, 2019
11 June, 2019The Premier Technical Event Where the Pharma Industry Meets
We are now less than five months away from the start of the 2019 ...We are now less than five months away from the start of the 2019 ISPE Annual Meeting & Expo being held this year in Las Vegas! The 2019 ISPE Annual Meeting & Expo is the prem... View All Blog Posts11 June, 2019 -
chapter Events
August23
21st Annual Golf Tournament
NEW THIS YEAR: Golf 101 Clinic Maybe you’ve wanted to...Strawberry Farms Golf Club
August 23, 2019View All EventsNEW THIS YEAR: Golf 101 Clinic Maybe you’ve wanted to be a part of the golf tournament but felt your game wasn’t up to par (wink!). Or, maybe you’ve always... -
Most Popular
September 2013
Pharmaceutical Engineering September / October 2013
September 2013Volume 33, Number 5 Table of Contents Supply Chain Management Labeling Pharma “Green” and Compliant in a Track and Trace World by Dana Buker, David Loy, and Harini Pillalamarri This...
Baseline GuidesBaseline Guide Vol 2: Oral Solid Dosage Forms
The ISPE Baseline Guide: OSD Forms is intended to offer a tool for consistent framework for regulatory interpretation, while still allowing a flexible, innovative, and compliant approach to facility design, construction, commissioning, and qualification. This approach is intended to allow manufacturers to better serve their customers by helping reduce costs and improve product quality.October272019 ISPE Annual Meeting & Expo
2019 ISPE Annual Meeting & Expo Modernize. Globalize. Transform. The...Caesars Palace Las Vegas
October 27, 2019View All Events2019 ISPE Annual Meeting & Expo Modernize. Globalize. Transform. The 2019 ISPE Annual Meeting & Expo will focus on excellence, modernization, and harmonization in pharmaceutical science and manufacturing across the...June242019 ISPE Cambridge In-Depth Pharma Training Series
Deep Dive Pharma Training Courses Gain solutions to your company's...June 24, 2019View All EventsDeep Dive Pharma Training Courses Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements. Real World Practice: Courses...
Guidance Documents
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GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records
GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records
PublishedThe ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records provides practical and pragmatic advice on areas such as regulated records, data flows, and risk management approaches, with particular focus on process control systems, manufacturing execution systems, and the interfaces and relationship between them. Additionally, system-specific examples of topics such as segregation of duties and critical validation activities to support data integrity are discussed. -
Good Practice Guide: Process Validation
Good Practice Guide: Process Validation
PublishedThe shift in process validation from a one-time event to the product lifecycle approach expected by most global markets has led to significant changes in validation practices. The science and risk-based approach combines product development knowledge with a structured process performance and product quality monitoring system to provide for validation throughout the product lifecycle. -
Good Practice Guide: Technology Transfer 3rd Edition
Good Practice Guide: Technology Transfer 3rd Edition
PublishedTransfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. Technology transfers take the outputs of process or method development activities and transfer the knowledge to a different location where a process or analytical procedure will be operated. -
Good Practice Guide: Single-Use Technology
Good Practice Guide: Single-Use Technology
PublishedSingle-use technology has grown in both complexity of design and criticality of application in the past twenty years, offering increased flexibility while significantly reducing the risk of contamination in manufacturing equipment. The implementation of single-use technology into a process requires a well-defined plan that minimizes surprises during the later stages of implementation.
ISPE Blog
Innovative technologies such as continuous manufacturing (CM) bring speed, efficiency, and agility to pharmaceutical manufacturing together with enhanced process robustness and assurance of product quality. During CM, material is simultaneously charged and discharged into process...
