January / February 2019

ISPE Briefs - 3 New ISPE Guidance Documents Debut

Beau Castro
New ISPE Guidance Documents

ISPE has released three new Guidance Documents:

Good Practice Guide: Single-Use Technology provides a road map for efficient implementation of single-use technology (SUT) with minimum disruptions to existing operations. From this Guide, users will learn how to select single-use components and design functional systems, when and how to perform effective extractables and leachables studies, how to evaluate suppliers of SUT, and about the interrelated tasks for implementing SUT. 

GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts provides detailed practical guidance to support data integrity within a regulated organization. Positioned under the GAMP® Guide: Records and Data Integrity and aligned with GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems, this guide provides detailed guidance in four core areas: data governance, data life cycle, risk management approaches, and critical thinking.

Japan Affiliate Pest Control Manual (English translation, version 4) expands on the Japan Affiliate’s previous Pest Control Manual, and offers advice for both new and aging GMP facilities. It proposes plans to incorporate pest control best practices into the project schedule for new construction, and includes advice on integrating pest control requirements during all phases of construction, training construction staff, and determining areas that should be inspected, both during and at the end of construction. 

Purchase these and other Guidance Documents on the ISPE website.

Singapore Affiliate Gmp Workshop Held in Cooperation with Drug Administration of Vietnam 

Just six months after meeting with the Drug Administration of Vietnam’s (DAV) Drug Quality Management Division, the ISPE Singapore Affiliate held its first GMP Workshop from 18 to 20 October in Ho Chi Minh City. About 150 participants attended from more than 65 companies and sites in Vietnam. The event was jointly organized with the Ministry of Health’s Centre of Training and Supporting Pharmaceutical, Cosmetic Enterprises.

The agenda covered pharmaceutical quality systems, data integrity requirements and regulatory expectations, quality risk management (QRM) principles and practice, managing GMP deviations using QRM, quality improvement, CAPA, and product quality reviews. Additional sessions included bioburden control, cleaning and disinfection, HVAC, and water system treatment.

Based on positive feedback, future events and programs to develop skills and knowledge for both industry members and regulators will follow. The affiliate also signed on 20 DAV regulators as ISPE members.

New Regulatory Resource

ISPE members can now access a carefully curated collection of regulatory updates. Each month, ISPE’s Regulatory Quality Harmonization Committee’s Europe–Middle East–Africa Regional Focus Group publishes a list of select updates that includes regulations, guidelines and other documents, and news about Brexit. 

We’d like to feature your group in an upcoming ISPE Briefs!

Share the highlights of training programs, conferences, social events, or other activities with ISPE members. Article length is 250–400 words; photos should be 300 dpi or > 1 MB. Send both to Susan Sandler, Editorial Director.