January / February 2019

Pharmaceutical Engineering January / February 2019

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Data integrity has been and continues to be an inherent aspect of global GMP regulations governing electronic and paper-based records in pharmaceutical manufacturing.

Data Integrity in the Trenches

Cover: Data integrity has been and continues to be an inherent aspect of global GMP regulations governing electronic and paper-based records in pharmaceutical manufacturing.

South African Pharmaceutical Industry: Workforce Appraisal and Proposed Development Strategy

Feature: As key developments unfold in its health care system, South Africa’s pharmaceutical workforce needs a plan for agile skills development and retention strategies.

How New Tech Can Propel Africa to the Forefront of Health Care

Feature: Lean innovations in medical technology can help provide more information, personalized tools, and better methods for promoting wellness in African countries.

In This Issue

Features
Pharmaceutical Engineering magazine’s March–April 2016 Special Report 1 highlighted the increasing importance of data integrity for companies throughout the global GMP-regulated industry. This is especially true during health authority inspections. 2 , 3 , 4 Pharmaceuticals, biotech, and API...
Insights
JSYK: JUST SO YOU KNOW Info from this issue 50% Percentage of FDA Warning Letters that cite data integrity issues, 2017–Q1 2018 Data Integrity 40% - 50% RFT error rate for paper-based laboratory records 15% - 25% How much...
Insights
On sitting down to write my first Chair’s column, I reflected on the events at our Annual Meeting & Expo in November. First, I want to commend the entire ISPE organization, and offer particular thanks to the 2018 Annual Meeting planning committee, for...
Insights
Over 2,000 attendees from more than 28 countries gathered in Philadelphia for the 2018 ISPE Annual Meeting & Expo on 4–7 November. Highlights below show the many ways that presenters captured the conference theme of “Vision to Reality”: in strides against disease, ISPE’s advancements over the last...
Insights
Happy 2019! The last time I saw many of you was at the ISPE 2018 Annual Meeting & Expo in Philadelphia, where I started my tenure as the ISPE International Young Professionals Chair.
Insights
Maritime discipline took the Boston Area Chapter President from a trawler to the boardroom. - It might seem odd to connect commercial fishing to the study of chemical engineering— and perhaps even more unlikely to connect commercial fishing to a career in the biopharmaceutical industry. But for...
Insights
Across industries, the trend is toward speed to market. - Whether it’s meeting consumer expectations for instant service or being the first to bring an innovation to shelves, companies have plenty of incentives to make products and services available faster.
Features
The 2018 ISPE Quality Manufacturing Conference , held 4–6 June 2018 in Arlington, Virginia, included a well-attended session entitled “Data Integrity—Beyond the Lab,” which reaffirmed continued focus from both industry and regulators on this critical element of assuring product quality and patient...
Features
Data is an important factor that is reshaping the pharmaceutical industry and triggering significant innovation. Vertical integration of equipment can represent an optimal solution to manage the increasing flow of data efficiently, innovate the manufacturing environment, and fulfill data integrity...
InTouch
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...
Technical
This article discusses how blockchain technology may disrupt the way we collect and manage data within regulated processes. The first section is a nontechnical summary of blockchain’s features, including a description of what it is (and what it is not). This sets the context for the next section,...