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Articles

The Ultimate API Cleaning Validation Protocol

May 18, 2012 | Comment (0) | cleaning-validation, validation-articles

Cleaning validation is a process to ensure that equipment cleaning procedures are removing residues to predetermined levels of acceptability. Although “equipment cleaning” is part of current Good Manufacturing Practice requirements the term “cleaning validation” was not popular until late 1980s. The need for a systematic approach to proving the effectiveness of all the cleaning procedures [...]

Five Questions You Need to Ask When Designing a HVAC System

May 14, 2012 | Comment (2) | process-validation, validation-articles

Environmental control is a very important part of any life science facility. The Heating, Ventilation & Air Conditioning (HVAC) system helps to ensure proper environmental conditions for your processes— whether in production, quality control, or research and development. The greater your cleanliness requirements, the greater the importance of the HVAC system. The HVAC system also [...]

Operations and Scheduling Aspects of Flexible Manufacturing Systems

May 9, 2012 | Comment (0) | manufacturing, validation-articles

Flexible Manufacturing Systems (FMS) are distinguished by the use of computer control. This enables FMS to reconfigure very rapidly to produce multiple part types which practically eliminates setup time. FMS’s are adopted in the manufacturing sector on account of additional advantages like high quality, low inventory costs and low labour costs. In this article, I [...]

MS Access Validation – Top Tips

Apr 7, 2010 | Comment (1) | software-validation, validation-articles

This article will present a simple method for validating MS Access databases for GXP use. The goal of our validation strategy is to provide better testing and documentation of individual databases in less time. Once we establish this methodology, we can rapidly apply it to many databases to reach compliance faster. This article will clearly [...]

Spreadsheet or Excel Validation, There is No Risk!

Jun 26, 2010 | Comment (0) | software-validation, validation-articles

Many companies don’t like to validate spreadsheets, some say it can’t be done. Is this just a myth? If you’ve got some data to compare or look for missing entries why do it manually? Because a human is more efficient than a computer? Right? Wrong, checking lists is boring – no one wants to do [...]

Levels Of Flexibilities In Flexible Manufacturing Systems

Apr 18, 2012 | Comment (0) | general-validation, manufacturing, validation-articles

Manufacturing flexibility is a major factor in development of production system. It also determines the level of competitiveness of manufacturing units and the ability of flexible production of goods compatible with the requirements of customers. Now a day’s manufacturing companies face increasingly frequent and unpredictable market changes because of global competition, frequent introduction of new [...]

Outsourcing Challenges and Strategies For Pharmaceutical Manufacturers

Apr 11, 2012 | Comment (1) | general-validation, validation-articles

Pharmaceutical outsourcing has been transformed from being a small incremental part of the typical pharmaceutical manufacturer’s business to one that is integral to almost every market segment. There are number of significant challenges within the pharmaceutical industry to better manage and outsourcing from both a strategic and operational perspective. The pharmaceutical companies are constantly revising [...]

Manufacturing Engineering Systems And The Challenges

Mar 30, 2012 | Comment (1) | general-validation, validation-articles

The aim of this article is to explore the understanding of Manufacturing Engineering Systems – Lean, Agile, Reconfigurable, Flexible, Balanced, Automated and Wise Manufacturing Systems in brief and its challenges. In order to sustain competitiveness in dynamic markets, manufacturing organizations should provide the sufficient flexibility to produce a variety of products on the same manufacturing [...]

Vendor Audits – Top Tips

Nov 5, 2009 | Comment (2) | software-validation, validation-articles

A vendor audit should consist of a comprehensive review of a software vendor’s system development practices to ensure that the system was developed, implemented, tested and maintained in a quality manner. Vendor Audits and the 483’s Skipping the vendor audit used to be prevalent in the industry, as a result of numerous 483’s were being [...]

21 CFR Part 11 – System Access to Authorized Individuals

Mar 16, 2012 | Comment (2) | software-validation, validation-articles

We all know the importance of 21 CFR Part 11 and in particular how people access these systems on a regular basis. For those of you who are not familiar with this regulation it is referenced in 11.10 “Controls for closed systems” and 11.30 “Controls for open systems: (ii) When an individual executes a series [...]

The 3 C’s: Impact on Vendor Qualifications in Bio-pharmaceutical Industry

Mar 12, 2012 | Comment (0) | general-validation, validation-articles

The biopharmaceutical industry is developing quickly and the quality systems are getting increasingly stringent so that margin of errors during selection, screening, processing, packing, testing, release and logistic support are becoming the crucial drivers. From concept to realization the whole process in this industry depends on crucial selection of vendors and timely execution of the [...]

What Problems Do You Currently Face with Batch Records?

Mar 13, 2012 | Comment (0) | general-validation, Polls

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Wireless Vs Wired Networks In a Regulated Environment

Apr 15, 2010 | Comment (0) | software-validation, validation-articles

Nowadays, most of us have either got a or used a wireless network of some description. Whether this is our home broadband or cable internet connection, a hotpot in Starbucks or simply a bluetooth connection on our mobile phone – we’ve used a wireless network. We’ve all without exception used hard-wired networks – computers that [...]

The Difference Between a FAT and a SAT

Apr 15, 2010 | Comment (6) | general-validation, validation-articles

It’s a question commonly asked in the validation arena, what is the difference between a FAT and a SAT. This article will finally explain what the difference is and how in your next interview you will know exactly why each one is required. Any project that involves equipment being developed from a third party should [...]

Constituents And Factors Of Technology Transfer In Pharmaceutical Industry

Feb 20, 2012 | Comment (3) | general-validation, validation-articles

Technology transfer is helpful to develop dosage forms in various ways as it provides efficiency in process, maintains quality of product, helps to achieve standardized process which facilitates cost effective production. It is the process by which an original innovator of technology makes its technology available to commercial partner that will exploit the technology. Technology [...]