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Top 10 Concerns Associated with Clinical Trials
June 18, 2013 | Clinical Trials
With the increasing number of discoveries in the field of medicine and an increase in number of diseases, causative agents and pollution, it becomes imperative to bring new medicines in the market. More and more CRO’s are emerging, which serve biotechnological, medical and pharmaceutical companies. Some of the well-known CROs are Covance which has lately [...]
New Forum – Good Automated Manufacturing Practice GAMP 5
June 17, 2013 | General Validation, Validation Articles
AskaboutValidation is pleased to announce the creation of our brand new GAMP 5 forum. Good Automated Manufacturing Practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. Good Manufacturing Practices More specifically, the ISPE’s [...]
Top Tips On How To Investigate Laboratory & Manfacturing Sterility Failures
June 5, 2013 | Manufacturing
Sterility can be defined as the freedom from the presence of viable microorganisms. However, the conditions that guarantee absolute sterility are usually too harsh for active ingredients, and the definition of sterility for a medicinal product must be defined in functional terms. What do you do when you encounter a sterility failure? It depends on [...]
10 Things To Consider When It Comes To Qualifying Autoclaves
May 27, 2013 | Equipment Validation, Validation Articles
Autoclave Validation / Qualification is mandatory for all machines used for biological sterilization, in the biomedical and pharmaceutical industries. Sterilization can be accomplished by either physical or chemical means. The principal physical means is autoclaving; other physical methods include boiling and dry heat. Chemicals used for sterilization include the gases ethylene oxide and formaldehyde, and [...]
Validation Deviations – An Important Part of Any Validation Project
May 20, 2013 | General Validation, Validation Articles
Validation deviations are just a part of life when you are working through validation protocols and test scripts; it’s highly unlikely that you will ever complete a full validation project without raising the odd validation deviation here and there. So what is a Deviation or Exception? It’s quite simple it’s an error or a failure [...]
New Book Release: Writing & Executing a Software Validation Protocol: Plain and Simple
May 15, 2013 | Software Validation, Validation Articles
This quick and easy guide describes methods and approaches for writing a validation protocol that can help ensure a thorough validation effort. It also provides some tips and tricks on executing the protocol and documenting the results. While this book was written primarily for those new to validation projects and the effort required gathering sufficient [...]
Software Validation Security Testing – 12 Items to Consider
May 7, 2013 | Software Validation, Validation Articles
I haven’t see a system yet that didn’t check password access, but most testing of Security features stops there. Even though Security is one of the critical “Big Three” drop-dead validation issues, it doesn’t get much attention by most companies. Therefore, you often see findings like this one made in an FDA 483: Testing of [...]
Software Validation in a Nutshell! The 5 Minute Guide to Understanding the Principles
April 19, 2013 | Software Validation, Validation Articles
Computer System Validation in a Nutshell! The 5 Minute Guide to Understanding the Principles 1. What is Software Validation? Software validation is part of computerized system validation (CSV). Computerized system validation defined as a documented evidence with a high degree of assurance that the software/computerized system, functions as per software design and user requirements in [...]
New Forum Just Launched “Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals”
April 15, 2013 | Manufacturing
First of all everyone here at the AAV offices would like to thank anyone who participated in our online survey last week, it was very informative for us and we learned what you like about our community and other areas that we need to improve on. One of the key areas of feedback was that [...]
Top Tips When Creating a URS for a Purified Water System
April 9, 2013 | Process Validation, Validation Articles
A User Requirement Specification (URS) is issued by the user to define the system requirements. Issuing a URS serves many purposes. For example it: Specifies the system’s parameters, regulations, and standards Establishes the base for pricing the new system Establishes the base for design, manufacturing, and validation Specifies deliveries Try to keep the system requirements [...]
Top 22 Reasons Why Risk Assessments are So Difficult?
April 2, 2013 | General Validation, Validation Articles
We all know the story, we need to validate a process/equipment/software so let’s use a risk based approach to apply scientific rationale and just test the components that are critical and key to enhancing patient safety and product quality. In reality performing a successful quality risk management approach is very difficult and often leads to [...]
Common Mistakes Made in Software Validation Operational Qualifications (OQ)
March 25, 2013 | Software Validation, Validation Articles
Overly Complex Test Objectives The reason you don’t want to cram as many functional features as possible into one test is that, in case one of the functions fail, you end up having to fail of the functions. This is because, if you are testing nine different things simultaneously and there is a major crash [...]
Validation Master Plans Vs Project Validation Plans
March 13, 2013 | General Validation, Validation Articles
As with all validation life-cycle documents, a validation master plan is a formal document produced by the pharmaceutical manufacturer. The plan should require that all validation documentation is under a strict document control procedure with issue and revision of documents controlled by means of an approval tables, identifying the name, signature, date, and level of [...]
Technology Trends Facing Life Sciences in 2013
March 4, 2013 | Validation Articles
According to PMLive.com, pharmaceutical companies and other players in the life sciences industry need to get to grips with new and potentially disruptive technologies to help them emerge from a challenging operating environment, says a new report. It is no secret that drugmakers have been taking a battering in recent years on the back of [...]
Reducing Validation Time and Cost: How GAMP & Risk Based Approaches are Reducing Costs
February 18, 2013 | Software Validation, Validation Articles
There is an expression: “Tell me what you believe, and I will be able to predict how you will act!” Many life science organizations generally accept that computer system validation takes a long time, costs a lot of money, and is difficult to manage effectively. Computer systems validation is generally accepted to contribute 25% to [...]
The Great Thermocouple Debate – Leave In or Leave Out!
February 13, 2013 | Manufacturing
The following question was posted in the forum last week in relation to thermocouples and it sparked a lot of debate around the use of thermocouples in manufacturing loads. All opinions are welcome, please leave your comment at the end of this article. Thermocouple Leave In or Leave Out? “Does anyone know if it’s acceptable [...]
Showing Insufficient Deviations to Support Comprehensive Testing
February 5, 2013 | Software Validation, Validation Articles
This one is tricky and by its nature highly controversial, deviations are not bad things when handled correctly they are a legitimate part of any system testing and should not be looked upon as bad work by the analyst. When an auditor assesses a system, they will rely on years of experience validating the same [...]