Displaying 1–25 of 64 results for cGMPs

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Solutions Update: Quality, Compliance, Regulatory and Risk Management ...

(Whitepaper)

Explore MasterControls’s quality, compliance and risk management solutions addressing these challenges.

eBook: Taking Control of Regulated Content and Data

(Whitepaper)

To help guide strategic thinking, this eBook offers a deeper dive into the benefits of content management applications in the regulated cloud and strategies for 21 CFR part 11 compliance.

Strategic Cold Chain Management: USP, EC and Evolving Regulations

(Whitepaper)

eBook on meeting USP and EU GDP regulatory requirements. Learn the latest revisions from the U.S. Pharmacopeial Convention (USP) Good Distribution Practices (GDP) according to the European Commission.

Enhancing Collaboration with the FDA Through eMDR

(Whitepaper)

Learn more about eMDR.

The Care & Feeding of a GxP-Compliant Environmental Monitoring System

(Whitepaper)

This App Note explains how to ensure continued GxP compliance in your monitoring system for temperature-controlled environments.

Managing your Risk Has Its Rewards: Making the Case for Risk Assessment in ...

(Whitepaper)

Managing your Risk Has Its Rewards: Making the Case for Risk Assessment in Streamlining your Quality and Compliance Processes

Six Corporate Oversights of Quality and Compliance Issues in Pharmaceutical ...

(Whitepaper)

Six Corporate Oversights of Quality and Compliance Issues in Pharmaceutical Environments

Qualifying Cold Chains, Writing Performance Qualifications and the Parenteral...

(Whitepaper)

Qualifying Cold Chains, Writing Performance Qualifications and the Parenteral Drug Association Technical Report 39

How to Avoid the Top 5 LIMS Nightmares

(Whitepaper)

Traditional Laboratory Information Management System (LIMS) implementations are notorious for keeping people awake at night. Industry analysts have estimated the failure rate of commercial LIMS solutions to be as high as 60 percent. If you find yourself waking in a cold sweat worrying about ...

New USP Sterile Water Testing Requirements

(Whitepaper)

On April 1, 2012, the United States Pharmacopiea (USP) published the removal of the legacy Oxidizable Substance test for the water monographs Sterile Water for Injection (WFI), Sterile Purified Water (PW), Sterile Water for Inhalation, and Sterile Water for Irrigation. The proposed revisions to ...

Ensuring Quality & Regulatory Compliance When Collaborating with a Service ...

(Whitepaper)

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.

Evaluating Library Databases for Microbial Identification: Critical Aspects ...

(Whitepaper)

A thorough evaluation process for microbial identification systems should consist of both a technical and financial review, regardless if you are performing internal testing and outsourcing. All evaluations should include a detailed list of specifications to meet your laboratory’s objectives. ...

Reducing Airborne Contaminants with Polymeric Floor Coverings

(Whitepaper)

A major medical device manufacturer has recently revealed significant airborne reduction counts. The facility based in the USA achieved this result by evaluating their contamination control methods at floor level. The facility was utilizing several hundred cases of peel off mats per annum. They ...

Competitiveness and Regulation: The FDA and the Future of America's ...

(Whitepaper)

This report by the California Healthcare Institute (CHI) and the Boston Consulting Group (BCG) highlights the critical role of the FDA in today's biomedical research and innovation ecosystem, and the need for a strong, science-based agency and an efficient, consistent and transparent regulatory ...

How to Respond to (and Avoid) FDA 483s

(Whitepaper)

This article shows excerpts from recent 483s issued for deviations tracking in tracking and recording environmental parameters in various applications and facilities. The article outlines ten best practices of a 483 response, providing a checklist to make the15-day response time limit more ...

Joining Forces: Bringing Pharma Supply Chain Management and Supply Quality ...

(Whitepaper)

For years, drug manufacturers have been caught between two opposing forces – supply chain management and supply quality management. The only way to confront these challenges is to create a “culture of quality” that begins at the top and permeates down through the supply chain. This paper looks at...

FDA Transparency Initiative: Opening FDA's 'Black Box'

(Whitepaper)

Transparency promotes accountability, enhances the work of the agency, and increases its credibility with the public. This article by FDA's Special Assistant to the Principal Deputy Commissioner, Afia K. Asamoah and published by FDLI outlines opening the proverbial 'black box' to help FDA more ...

Enhancing Collaboration with the FDA Through MedWatch Plus

(Whitepaper)

This white paper will provide an overview of the benefits and best practices of using the FDA's MedWatch Plus initiative for electronic adverse event reporting within the pharmaceutical industry, as well as other FDA-regulated organizations.

Accounting for Risk in Your Asset Management Strategy

(Whitepaper)

A risk-based asset management system will help you appropriately prioritize how you spend time, money and materials fixing the most critical problems, provide the infrastructure for continuous improvement and help you meet your corporate business objectives, including regulatory compliance. This ...

Integrating Good Manufacturing Practices During the Transition from Clinical ...

(Whitepaper)

Our experience shows that early adoption of GMP (Good Manufacturing Practices) by a company, can lead to a faster, lower-cost ramp-up from clinical trials to full commercial manufacturing, in-house or out-sourced. The interpretation of compliance regulations, and subsequent recommendations in ...

Current Trends in GMP Warning Letters

(Whitepaper)

A detailed look at FDA's 2008-2009 Warning Letters, courtesy of Hogan & Hartson LLP.

Imperfect Harmony: Life Sciences Companies Must Partner to Thrive

(Whitepaper)

A just-released IBM study suggests that if life sciences companies do not collaborate, they risk delays in production. The survey, "An Imperfect Harmony: Alliances within the Life Sciences Industry," says that while the number of partnerships between larger and smaller life-sciences companies has...

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