http://www.scientistsolutions.com/f269-good+manufacturing_validation+practice+gmp_gvp.html Control and management Life Science Discussion en-us sci7feed@sci7.nojunkorherepleasespam.com hourly 1 2005-05-05T12:00+00:00 http://www.scientistsolutions.com/t14352-deviation+from+pharmacopiea+spec_s.html Mon, 12 Apr 2010 02:19:00 GMT http://www.scientistsolutions.com/t14144-source+water+contamination.html ]]> Mon, 15 Mar 2010 10:29:14 GMT http://www.scientistsolutions.com/t13655-raw+materials+expiry+date.html Hi,
I am currently working in an In vitro diagnostic company and I am doing a study about expiry date of raw materials after package opening. It is hard to find datas about that and I try to extrapolate informations from unopened raw material package. I deduced 3 options to consider:
1. Contact the vendor for data;
2. Perform your own accelerated ageing, and concurrently, set aside product (the RM and/or the finished product) for real-time studies; sufficient qty to pull a...]]> Fri, 22 Jan 2010 02:49:00 GMT http://www.scientistsolutions.com/t12883-reworking+of+biologicals.html Still no reply from anybody.]]> Thu, 15 Oct 2009 01:21:14 GMT http://www.scientistsolutions.com/t12714-neuroglobin.html ]]> Sun, 27 Sep 2009 14:16:15 GMT http://www.scientistsolutions.com/t12713-neuroglobin.html ]]> Sun, 27 Sep 2009 14:16:13 GMT http://www.scientistsolutions.com/t11754-sop+page+signatures.html Does anybody know if is mandatory to sign on each page of POS? What are requirements ragarding this aspect for FDA regulations and for EMEA regulations.
The sign to be written is:
The author of the procedure
The verifing person
The person who aprove POS
Thanks.]]> Wed, 08 Jul 2009 06:00:49 GMT http://www.scientistsolutions.com/t11140-rework+procedure.html Does anyone know the steps necessary in rework of finished product? Can anyone spare a Rework procedure?Or a few indications?Thanks.]]> Thu, 11 Jun 2009 07:54:42 GMT http://www.scientistsolutions.com/t8701-gmp+sops.html I am new in this forum, so if I posted wrong, please forgive me. I work for a short time in a drug manufacturing factory. The medicines we are producing are for animals. I was designated to implement GMP system in our company. But I know relatively about GMP. My first question is: does anyone have a list of SOPs to be done in such company? I know I must have SOP for everything We do, but I don't know which.Can anyone help me?Thanks.]]> Tue, 27 Jan 2009 11:28:01 GMT http://www.scientistsolutions.com/t8414-retesting+of+raw+materials.html Tue, 30 Dec 2008 13:52:12 GMT http://www.scientistsolutions.com/t4006-how+are+ranges+of+tablet+press+speeds+handled+in+validation_.html ]]> Mon, 26 Mar 2007 13:42:27 GMT http://www.scientistsolutions.com/t2565-performance+qualification+pq+of+laboratory+glassware+washer.html In general, it seems that most labs have avoided placing acceptance criteria on the cleanliness of their glassware, deferring to no visible contamination as being their guideline.
The equipment manufacture suggested developing an HPLC method to test for residual detergen...]]> Wed, 02 Aug 2006 15:51:52 GMT http://www.scientistsolutions.com/t2247-drugs+and+nanotech.html I was reading an article in the newspaper (L.A. times) recently which described how nanotechnology may start to play a role in drug delivery. This is not my area of expertise, but I was wondering what others thought about this. Are any of you out there seeing a trend in nanotechnology and its involvement in drug development? If so, in what way?
Best wishes,
Kevin.]]> Fri, 19 May 2006 00:33:54 GMT http://www.scientistsolutions.com/t2246-institute+of+validation+technology+_+link+to+list+of+upcoming+conferences.html Thu, 18 May 2006 23:33:18 GMT http://www.scientistsolutions.com/t1195-antibody+purification+validation.html Thu, 11 Aug 2005 17:23:37 GMT http://www.scientistsolutions.com/t1090-process+validation.html Thu, 14 Jul 2005 05:19:11 GMT http://www.scientistsolutions.com/t1084-tea+tree+oil+monograph.html -Bettye]]> Tue, 12 Jul 2005 18:25:56 GMT http://www.scientistsolutions.com/t936-validation+study+of+chloroxylenol_.html Has anyone done a validation or an HPLC study of degradation of chloroxylenol? In particular, what's the best way to accelerate degradation? oxidation? acid hydrolysis?
We've been trying to analyze chloroxylenol in our product, but I think our excipients are interfering with our results. We are using RP HPLC with a C18 column and getting a peak with a shoulder. Any thoughts? We are going to try a gradient of water/methanol. Think that will work?]]> Wed, 01 Jun 2005 00:40:55 GMT http://www.scientistsolutions.com/t890-disinfectant+compatability.html jim achmoody
]]> Sun, 15 May 2005 00:11:16 GMT http://www.scientistsolutions.com/t690-nir+or+similar+techniques+for+blend+uniformity%2c+do+they+work_.html Mon, 28 Mar 2005 14:29:18 GMT