The 9 Most Common Validation Problems
Frank Houston, EduQuest
What validation problems are you likely to see over and over? When tackling complex validation challenges, you’ll save time, money and headaches when you know the most common problems and where to find them. The following analysis is based on validation work EduQuest performed for a large FDA-regulated company over the past year. The goal was to bring the company’s software validation evidence up to the level of the U.S. FDA’s current expectations as well as those of the client’s own independent auditor. Our efforts yielded 1,720 observations.
As part of a “lessons learned” review, we categorized the observations and identified which documents contained them. The results – in our experience – are typical of the problems most companies face.
Thermal Validation: Measure Right for your Range
The AskAboutValidation Team
Economic pressures demand that operational inefficiencies be addressed and the highly regulated pharmaceutical industry is no exception. In past years, the need to ensure accuracy of measurement and documentation of data superseded any cost/time cutting methods. Inherent sources of inaccuracy had to be offset as best as possible, despite long, time-consuming methods meant to maintain accuracy and verify results. Thermal validation is a perfect example of this, with pre- and post calibration being de rigueur in mapping projects.
However, as improved technologies emerge, calibration of measurement devices is one area that can be made more efficient.
Typical calibration protocols specify pre- and post-calibrations. But, much of the associated expenditures in time and labor in thermal validation can be greatly reduced if the right tool is used. A more efficient approach to temperature mapping is to look at the temperature range to be mapped and use the most suitable instrument for that range, which allows pre- and post-calibration steps to be entirely eliminated.
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Writing an Effective Cleaning Procedure : A successful start to cleaning process of the equipment
During early stages of the cleaning method validation or after introduction of the new process equipment or cleaning equipment the egg and hen dilemma (Cleaning SOP first or cleaning validation first) is normally observed.
Documentation flow in the water generation and distribution system qualification program
The Water generation and distribution system has very high importance in Pharmaceuticals and it becomes very critical when it is Injectable unit. The qualification procedure of the Water generation and distribution system is well described in the various guidelines.
Packaging Sealing Validation - A Simple Example
Once upon a time, a company decided to improve their packaging sealing process. They selected equipment with a new technology that would process more product in less time with improved seal characteristics.
Qualification of Water Systems
Water is one of the most widely used substances, and raw materials, or an ingredient in the production, processing, and formulation of pharmaceuticals.
General Test Script Instructions (CSV)
So the time has come to execute your test protocols, you’ve spent days tweaking and refining your test cases to ensure that they work first time round and you’ll end up with as few deviations and discrepancies as humanly possible.
Cleaning Validation: Types of Contamination
It is beneficial to begin the subject of cleaning with a description of how products become contaminated and a brief description of some contaminants.
Validation of MS Access Databases
This article will present a simple method for validating MS Access databases for GXP use.
How to Create a Bullet-Proof URS
Over the last number of months it has become quite apparent to us at Askaboutvalidation.com that many of you out there are finding it difficult to create URS documents (for the beginners out there User Requirement Specification’s).
EN285, HTM2010, 2031 guidelines state - Steam quality, purity and quantity can be affected by the design, use, and maintenance of the overall steam system.
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Store the dry and wet chemicals separately.
Hello, We have several air flow cabins, when we measure the air velocity (0.45m/s +/- 20%), - in wich rule appear the exactly number of points to measure the velocity? - all the points measured need to comply with the acceptance ...
Posted By: AranEP in ANALYTICAL EQUIPMENT VALIDATION : 0 responses
Why media fill simulation bracketing is accepted in regulatory. Is there any rational for that.Can any one define this. Thanks in advance..:) R.Dasarath ...
Posted By: rdasaratharamireddy in GVP - GOOD VALIDATION PRACTICE : 0 responses
Dear All While performing Tunnel validation using [B]z value of 46.4[/B] and achieving [B]exposure time of minimum 3 min [/B]during sterilization at [B]temperature of 300 deg[/B] and more. Does this meet the acceptance criteria for depyrogenation & sterilization. I also ...
Posted By: annie in ANALYTICAL EQUIPMENT VALIDATION : 3 responses
SMF and VMP how the review period will be decided and at which situation there documents will be reviewed ...
Posted By: SBD in METHOD & ANALYTICAL VALIDATION : 0 responses
Hi The repeatability test in USP<1225> should be assessed using a minimum of nine determinations covering the specified range for the procedure. Usually three concentrations and three replicates of each concentration or using a minimum of six determinations at 100% of the ...
Posted By: Jay Naidoo in METHOD & ANALYTICAL VALIDATION : 0 responses
I need the source code of ubug12, because i m working in linux and I Trying to develop a program similiar to ubug12 but for linux, I really will be grateful if any help me??? ...
By: Ranana_Hema in RISK ASSESSMENT : 5 responses
Get some round wood in the form of 10mm diameter and what ever length you can get. Any DIY shop will stock such it. Measure the distance between your shelves, then cut your wood rods into lengths that are around ...
By: alexkennedy in OQ (OPERATIONAL QUALIFICATION) : 2 responses
Hello Dear Thanks for your valuable & prompt answer. But I am not clear on idea that, we are validating the cleaning procedure for previous product( for the API used in manufacturing). Again for clening we are using NaOH solution. Then please ...
By: bijaykmohalik in 21 CFR PART 11 : 3 responses
We do something similar - if it's a paper document, I think that a stamp saying "no change" could be used if there is also a name, job title, signature and date which would show the review has been done. ...
By: Cat in QUALITY MANAGEMENT SYSTEMS - ISO 9001:2000 : 1 responses
Hello, We have several air flow cabins, when we measure the air velocity (0.45m/s +/- 20%), - in wich rule appear the exactly number of points to measure the velocity? - all the points measured need to comply with the acceptance ...
By: AranEP in ANALYTICAL EQUIPMENT VALIDATION : 0 responses
I want to implement ISO 9001:2000 and i'm at the document preparation step. Could s.o help me with Operating procedures templates and forms (example doc) for the standard OP or ISO 9001 manager software. ...
Posted By: ChrisOB in QUALITY MANAGEMENT SYSTEMS - ISO 9001:2000: 3 responses
dear colleagues Atached is a WHO guidelines on how to write IQ, OQ, PQ and process validation. I thought of sharing this with you. best regards Mediana ...
Posted By: me_av@hotmail.com in GVP - GOOD VALIDATION PRACTICE: 21 responses
Hello All, As some of you might know we are currently getting our wonderful site re-designed as we feel now we have great user base who deserve a better website. We are looking for comments from our members in relation ...
Posted By: gokeeffe in GENERAL DISCUSSIONS: 46 responses
Hi All, As we are a new growing community we are always looking for idea's to improve out validation forum. Please list any idea's that you might have that could add to our continual growth. We had an amazing 250,000 ...
Posted By: admin in GENERAL DISCUSSIONS: 32 responses
Hello, We have several air flow cabins, when we measure the air velocity (0.45m/s +/- 20%), - in wich rule appear the exactly number of points to measure the velocity? - all the points measured need to comply with the acceptance ...
Posted By: AranEP in ANALYTICAL EQUIPMENT VALIDATION: 0 responses
Why media fill simulation bracketing is accepted in regulatory. Is there any rational for that.Can any one define this. Thanks in advance..:) R.Dasarath ...
Posted By: rdasaratharamireddy in GVP - GOOD VALIDATION PRACTICE: 0 responses
SMF and VMP how the review period will be decided and at which situation there documents will be reviewed ...
Posted By: SBD in METHOD & ANALYTICAL VALIDATION: 0 responses