Ensuring Quality & Regulatory Compliance when Collaborating with a Service Provider

Sponsored By: DPT Laboratories
In recent years, the pharmaceutical industry has given greater priority and attention to quality assurance and regulatory compliance than ever before. With the FDA’s heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure Current Good Manufacturing Practices (cGMP) are top of mind, and sponsors are placing greater responsibility for meeting cGMP requirements onto their outsourcing partners. While both sponsor companies and service providers must adhere to robust quality standards and undergo regular regulatory inspections, manufacturers are ultimately held responsible by regulatory agencies when it comes to adhering to cGMPs.

Using Raman Chemical Imaging to Analyze Inhaled Combination Therapies
Author: Dr. Oksana Olkhovyk
Sponsored By: Gateway Analytical
This white paper discusses using Raman Chemical Imaging as method to analyze dry powder formulations containing multiple active ingredients in order to obtain important data about the aerosolization behavior that was previously unavailable. This analysis offers developers new opportunities to optimize the formulations and the delivery devices for combination therapies.

Process Analytical Technology as Key Enabler of QbD
Authors: David W. Humphrey/Dr. Brandye Smith-Goettler
Sponsored By: Siemens AG
The Food and Drug Administration (FDA) has championed one initiative, known as Quality by Design (QbD), with the goal of improving productivity and reducing manufacturing costs. Process analytical technology (PAT) is an enabling technology for QbD. Siemens offers a comprehensive, well-integrated solution for process analytical technology called SIPAT.

Implementing Disposable Cleanroom Apparel into the Manufacturing Process
Author: Damon Larking
Sponsored By: Kimberly-Clark Professional
This paper addresses the benefits of disposable cleanroom apparel versus reusable apparel. It explains how disposable cleanroom apparel can help play a role in helping pharmaceutical manufacturers reduce their waste stream while reducing the risk of contamination.

Three Steps to USP H₂O Success
Author: Geoff Sheffrin
Sponsored By: OBK Technology Ltd.
USP water systems are highly specific in their requirements. To get there successfully is relatively easy BUT you are dealing with a large number of detailed requirements that MUST work in harmony to produce reliable Purified Water or Water for Injection — cost effectively and with minimum maintenance. Here's how.

Improving Product Quality with Risk Assessment Tools
Author: Brenda Percy
Sponsored By: EtQ Inc.
With the product lifecycle moving so fast, many organizations may ask the question, "How can we effectively measure quality?" The answer is Risk Management. Learn the elements of Risk Management and how they help to identify, prevent, and mitigate risk throughout an organization.

Establishing a Culture of Quality
Author: Ron Johnson, President, Becker & Associates Consulting
Sponsored By: NSF Becker
For companies seeking to prevent or remediate regulatory compliance violations, establishing a culture of quality is of the essence. In industries strongly affected by regulatory compliance, product quality is inextricably linked to a company’s well-being. Learn more about cultivating and nourishing a culture of quality in your firm.

OPC: The Ins and Outs to What It's About
Author: Darek Kominek
Sponsored By: Matrikon OPC
The Every Man's Guide to OPC is an easy-to-read overview of the most popular industrial open connectivity standard, OPC. This paper first introduces the main idea behind OPC, shows why OPC is different from conventional (often proprietary) communication protocols, and explains how OPC helps overcome the limitations of such native protocols.

Finding the Balance Between Pharmaceutical Quality Management and Manufacturing Productivity
Author: Jim Morris, Partner at NSF-DBA LLC, part of NSF Health Sciences
Sponsored By: NSF-DBA (USA) LLC
In the pharmaceutical manufacturing industry, our primary concern must always be the quality and safety of our processes and the products we produce. If we don't focus appropriately on developing robust quality management systems, we risk consumer safety and put our companies at risk of regulatory action. Learn more about how to achieve this in this white paper from the experts at NSF-DBA LLC.