Gmp-validation-compliance - gmp-validation-compliance.com - Recent Discussions on GXP4
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Safe operations and safety management 6 Aug 2012 | 02:32 pm
Plant layout Operating procedures and systems of work Plant safety and training officer Training of operators Housekeeping and maintenance Operator hygiene Emergency procedures Safety analysis Worker ...
Retesting antibiotic API 6 Aug 2012 | 12:31 pm
I was wanting to know what the guidelines are for retesting antibiotic APIs once they have passed their expiry or retest date?. What is required to retest them to allow their use?
Validation Master Plan and Validation of Computerized Systems 27 Jul 2012 | 10:37 am
Hi, currently, im working with our document, anyone from the group can assist me? Any assistance is highly appreciated! Thank you in advanced!
Management Review meeting minutes 19 Jul 2012 | 12:40 pm
Hello please find the attached document of management review meeting template with explaination
oil in cleanroom 13 Jul 2012 | 01:56 pm
Hello everyone, Can anyone please suggest me which oil is recommended for maintainance of motors in cleanroom. which oil comply with cleanrrom requirement
Help product failed 11 Jul 2012 | 12:55 pm
Hello Guys, can any one suggest some idea, like in my company some product has been failed in testing but upper management still want to sell it and asking QA to sign for it, i think this kind of con...
Risk Analysis, five why analysis 4 Jul 2012 | 12:39 pm
Define the problem and/or risk and question including pertinent assumptions identifying the potential for risk. Three fundamental questions are often asked • What might go wrong? • What is the likeli...
Risk Management process steps 4 Jul 2012 | 12:31 pm
The process includes following elements or steps • Risk analysis • Risk evaluation • Risk control • Risk communication • Overall residual risk evaluation • Post production information
Validation of Autoclave protocol 4 Jul 2012 | 12:02 pm
Can anyone please provide a template for an Autoclave Validation protocol? A simple performance validation protocol
Who is responsible for product related issue sponsars or manufacturers 4 Jul 2012 | 09:44 am
If we have issue with product, who obligation is higher towards product?
