Displaying 1–25 of 47 results for Facilty Design & Management

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Facilities and Operational Investment 2016 eBook

(Whitepaper)

Pharma’s leaders continue to pursue success through a strategy of careful capital expenditure investment with an eye on increased capacity, speed and efficiency in their facilities.

eBook: Facilities and Operational Investment

(Whitepaper)

Pharma’s operational excellence is being fueled by increased capital spending.

eBook: Pharmaceutical Equipment & Manufacturing Trends

(Whitepaper)

The pharmaceutical manufacturing landscape has changed notably over the past decade and is continuing to evolve rapidly. Pharmaceutical manufacturers have begun to wield some new tools, nailing down new efficiencies and better drugs in the process.

Special Report: Facilities of the Future - Agile and Flexible

(Whitepaper)

Just a decade ago, it could take four to six years to bring a new biopharma plant onstream. Today, thanks to modular construction and single-use processing equipment, a multipurpose facility can be brought online in as little as 12 months. Timelines are shrinking to a point where they may soon be...

GMP Warehouse Mapping: Step-by-Step Guidelines for Validating Life Science ...

(Whitepaper)

This step-by-step guide describes how to map a warehouse to comply with internationally recognized GMPs-including many that have been published or revised recently. It draws on Vaisala's extensive experience in environmental and industrial measurement and monitoring throughout over 150 countries.

Implementing 5S Workplace Organization Methodology Programs In Manufacturing ...

(Whitepaper)

Many manufacturing facilities have opted to follow the path towards a “5S” workplace organizational and housekeeping methodology as part of continuous improvement or lean manufacturing processes.

Six Key Predictors of Outsourcing Success In A Maturing RE & FM Outsourcing ...

(Whitepaper)

In this white paper, Nicole Ballard and Rakesh Kishan of UMS Advisory, Inc., provide an overview of the RE & FM Outsourcing Market and address main waves of market maturity. In particular, they examine significant outsourcing deals.

A Rapid and Sensitive UPLC/UV/MS Method for Simvastatin and Lovastatin in ...

(Whitepaper)

The analytical selectivity, sensitivity, and throughput of Waters ACQUITY UPLC Systems enhances cleaning validation studies, resulting in more confidence in results and significant cost savings. UPLC enables manufacturing plants to move through production batches faster, increasing productivity ...

Use of Universal HPLC Detection for Cleaning Validations

(Whitepaper)

Several methods and traditional cleaning solvents for manufacturing devices spiked with typical drug substances and impurities were measured using HPLC-UV and CAD detection. HPLC with CAD provides a more complete view of the data since the CAD response has less solvent interferences and does not ...

Sustainability Solutions for the Bottom Line: Adopting an In-House Energy ...

(Whitepaper)

Traditional third party industrial energy management programs often provide little energy savings benefits. Many recommendations remain unimplemented due to the owners’ lack of resources and technical and financial know-how. This paper describes a new approach achieved by a hands-on training and ...

How to Prepare for an Inspection of Your Company's Information Integrity

(Whitepaper)

Last year, 95% of all regulatory enforcement focused on one topic: the integrity - or lack thereof - of a company's information. Cerulean recommends the steps to prepare for an inspection of information integrity.

Prioritizing Maintenance, Reducing Costs

(Whitepaper)

By targeting electrical distribution equipment most in need of maintenance, manufacturers can cut costs and redirect funds toward more effective predictive practices or capital improvements.

Five Key Steps to Minimizing Risk During GMP Site Renovations

(Whitepaper)

Renovating any facility while manufacturing is going on poses a number of risks. This position paper by John Buescher and Tom Kreher of McCarthy Building Companies outlines top priorities and how to address them.

FDA-CDER Compliance Policy Guide for the PDMA

(Whitepaper)

This document is intended to clarify for FDA personnel and the regulated industry how the agency intends to prioritize its enforcement efforts regarding the pedigree requirements in 21 U.S.C. 353(e)(1)(A) and 21 CFR Part 203 during the first year after the effective date of 21 CFR §§ 203.3(u) and...

Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP ...

(Whitepaper)

This guidance is intended to help manufacturers implement modern quality systems and risk management approaches to meet the requirements of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211). The guidance describes a comprehensive quality systems (QS) ...

FDA's Guidance on Effective Quality Risk Management

(Whitepaper)

FDA's guidance on effective quality risk management approach can ensure high quality of the drug product to the patient by providing a proactive means to identify and control potential quality issues during development and manufacturing of pharmaceutical products.

[Report on] the Food and Drug Administration’s National Drug Code Directory

(Whitepaper)

HHS’ OIG found that the Directory is incomplete (with an estimated 9,187 prescription drug products missing) and inaccurate, (with an estimated 34,257 drug products no longer on the market or listed in error). The Office’s report also concluded that FDA’s drug product listing process and lack of ...

Process Modeling and Control Challenges in the Pharmaceutical Industry

(Whitepaper)

In this 2003 presentation made at a conference held by the University of Texas, Phil Dell'Orco, GSK's Leader for Process Safety and Design, summarized the challenges facing engineers as they work to improve control of pharmaceutical processes in an industry still dominated by chemists.

U.S.A. GMPs: What Offshore API Manufacturers Need to Know

(Whitepaper)

This 341-page document, based on a course that was presented at Beijing University last year by Nicholas Buhay, Deputy Director of Manufacturing and Product Quality for FDA's CDER, summarizes GMP requirements and provides background on the history of the regulations within the U.S.

Overview of the Environmental Impact of Pharma Operations on Water Systems

(Whitepaper)

This white paper from Santa Clara, Calif., was prepared as a way to initiate dialogue on pharma waste disposal to municipal sewer systems.

A Profile of the Pharmaceutical Manufacturing Industry

(Whitepaper)

Aiming to develop integrated environmental policies that address the inter-relationships among pollutant releases to air, water and land, in the late 1990s EPA adopted a whole-facility focus. Recognition of the need to develop an industrial “sector-based” approach within the EPA Office of ...

Thermal Validation in the Pharmaceutical Industry

(Whitepaper)

Thermal validation is the process of validating / qualifying equipment and storage facilities to prove that they will create and maintain the temperatures they are designed for. Veriteq Instruments representatives explain why thermistor sensors are more appropriate to most pharmaceutical ...

Talk to Me, Supply Chain: Voice-Activating the Warehouse

(Whitepaper)

Voice-directed work in the warehouse is coming of age, and has the potential to enhance warehouse productivity and safety, says AMR Research’s Greg Aimi.

How to Implement an Infrared Plant Maintenance Program

(Whitepaper)

Thermal imaging is a critical part of plant maintenance program. Fluke Corp., which owns Raytec and recently added Infrared Solutions to its product line, offers start-up tips and integration solutions.

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