Whitepapers - Pharmaceutical Technology

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PharmTech Europe

Whitepapers

Three Steps to USP H2O Success

April 25, 2013

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

November 1, 2012

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.

OPC: The Ins and Outs to What It's About

May 1, 2013

The Every Man's Guide to OPC is an easy-to-read overview of the most popular industrial open connectivity standar - 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.

Establishing a Culture of Quality

April 25, 2013

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.

Ensuring Quality & Regulatory Compliance when Collaborating with a Service Provider

April 25, 2013

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.

Is My Method (Still) Valid?

April 25, 2013

This paper outlines the importance of method validation including the official requirements, characteristics to be validated and minimum requirements, helping to ensure that the data generated are reliable.

How to Select an Environmentally Preferable Chamber

April 25, 2013

How to Select an Environmentally Preferable Chamber

Don't Overlook Pharmaceutical Supply Chain Quality Provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA)

March 28, 2013

The Food and Drug Administration Safety and Innovation Act (FDASIA) is a remarkably broad law with far-reaching implications for the pharmaceutical industry. Several provisions of the law focus on ensuring safety and quality in the increasingly global pharmaceutical supply chain. Learn more?

Coating heat-sensitive products at ambient temperatures

March 28, 2013

See how LYCOAT® / ReadiLYCOAT® can be applied to your heat-sensitive ingredients or dosage forms at the same time as keeping the coating process short and providing an inert coating of perfect quality. And that?s not all?..

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