http://www.askaboutvalidation.com/forum/ askaboutvalidation.com connecting the Life Sciences,validation forum,validation,validation questions,validation answers,process validation,software validation,cleaning validation,premier validation, fda forums,askaboutvalidation,askaboutvalidation.com,validation boards, validation companies, validation answers, software validation, software compliance, validation questions, validation answers,validation ireland, validation in ireland,process validation,cleaning validation,software validation,six sigma en Mon, 06 Sep 2010 19:41:45 GMT vBulletin 60 http://www.askaboutvalidation.com/forum/images/misc/rss.jpg http://www.askaboutvalidation.com/forum/ http://www.askaboutvalidation.com/forum/showthread.php?t=3470&goto=newpost Mon, 06 Sep 2010 02:52:32 GMT Image: http://i.i.com.com/cnwk.1d/i/tim//2010/09/02/sony-walkman-s.gif Sony has eked out a small victory against Apple in the market for portable... Sony has eked out a small victory against Apple in the market for portable music players.Sales of Sony's Walkman ffxiv power leveling line beat those of Apple's iPod line in Japan for the month of August, according to survey results released Thursday by BCN, a Tokyo-based research firm. During August, Sony took a 47.8 percent share Final Fantasy XIV Power leveling of the portable music player market, while Apple captured 44 percent. This marks the first time that Sony has inched ahead of Apple in a monthly tally since BCN began its surveys in 2001.If it sounds like you've heard this news before, well, that's because you have. Sort of. It was a year ago almost FF14 Power leveling to the day that BCN reported higher sales for Sony's player in late August--but that victory was just for a single week. Of course, timing is everything. In both cases, the Walkman outsold the iPod just ahead of Apple's annual refresh of ffxiv powerleveling its iPod lineup. So Sony likely received a temporary boost from customers who held off buying iPods until the new models hit the market in September, according to BCN. The survey results also include only dedicated music players, leaving out Apple's iPhone.But also, BCN said, the Japanese electronics giant has been trying to push more affordable products, a strategy that may have helped Walkman sales last month as well.Collectively, Apple Final Fantasy XIV Power leveling and Sony own 90 percent of the portable audio player market in Japan, with about a dozen other vendors duking it out for the remaining 10 percent, according to BCN (Google Translate version).On Wednesday, meanwhile, Sony used the IFA show in Berlin to unveil its new, cloud-based Music Unlimited service, venturing once again into waters dominated by Apple's iTunes service. ]]> SIX SIGMA FORUM amineserlt http://www.askaboutvalidation.com/forum/showthread.php?t=3470 http://www.askaboutvalidation.com/forum/showthread.php?t=3466&goto=newpost Fri, 03 Sep 2010 13:31:26 GMT Hi, I work for an instrumentation manufacturer, one of the products in the range has just had software developed for it and one appliaction (of many... Hi,
I work for an instrumentation manufacturer, one of the products in the range has just had software developed for it and one appliaction (of many different industrial applications) is in pharma settings. Some customers who are interested in the new software ask about validation. Please can you tell me what exactly 'we' the manufacturer (who obviously developed the software) has to do to validate the software. Many thanks for your advice. KLEE ]]> SOFTWARE VALIDATION DOCUMENTATION KLEE http://www.askaboutvalidation.com/forum/showthread.php?t=3466 http://www.askaboutvalidation.com/forum/showthread.php?t=3465&goto=newpost Thu, 02 Sep 2010 18:21:52 GMT I am trying to calculate the MACO for a mouthwash so the acceptable daily intake is not applicable. Would the following calculation be acceptable? ... I am trying to calculate the MACO for a mouthwash so the acceptable daily intake is not applicable. Would the following calculation be acceptable?

MACO = mg analyte product A divided by kg batch size of product A x weight in kg of the smalles batch size (product B) divided by a safety factor of 1000 x product contact surface area of shared equipment.

For example:6.63 kg of sodium fluoride per 600 kg batch = 6, 630,000 mg/600 kg =11,050 mg NaF/kg batch
11,050 mg NaF/kg x 19 F- /42 NaF = 4999 mg Fluoride ion/kg batch
Shared equipment = 21,106 in2
Safety factor = 1000
Smallest batch size = 6000 kg

Calculation:

MACO = 4999 mg F- x 600 kg (smallest batch) =0.1421 mg Fluoride Ion/in2
Kg batch 1000 x 21,106 in2

Therefore, for a 9 in2 swab area, the maximum allowable fluoride residue is 1.28 mg F- .
Thus this make sense? ]]> CLEANING VALIDATION gsmith4341 http://www.askaboutvalidation.com/forum/showthread.php?t=3465 http://www.askaboutvalidation.com/forum/showthread.php?t=3464&goto=newpost Thu, 02 Sep 2010 10:22:47 GMT Dear Friends, Some of the products are transferred within sites (ie.,from site 1 to site 2 ) permanently. In that case we perform concurrent... Dear Friends,

Some of the products are transferred within sites (ie.,from site 1 to site 2 ) permanently. In that case we perform concurrent validation for the transferred products. Suppose if the product is filed for any regulated markets, generally exhibit validation batch reports should be submitted.
My doubt is, the exhibit validation batch reports will be as per site 1 (w.r.t environmental control, mfg process, equipment operation..) but when the product is transferred to site 2 i believe some changes will be there (w.r.t environmental control,mfg process , equipment operation).

a) In what way this transfer from site 1 to site 2 affect the product quality.

b) Stability status of the product, when the product is cross referred to exhibit valildation batch .

c) If so is it sufficient to submit only the concurrent validation report to the regulated market of site 2 .
or
d) We have to submit the exhibit validation batch report of site 1 & concurrent validation report of site 2 .

Can any one suggest, how can we justify this change in validation

Thanks

sowmya ]]> GVP - GOOD VALIDATION PRACTICE sowmya http://www.askaboutvalidation.com/forum/showthread.php?t=3464 http://www.askaboutvalidation.com/forum/showthread.php?t=3463&goto=newpost Thu, 02 Sep 2010 09:09:12 GMT Is the criterion of having a direct contact with product/semiproduct/raw material sufficient to perform IQ of the device/machine/system? Please,... Is the criterion of having a direct contact with product/semiproduct/raw material sufficient to perform IQ of the device/machine/system?

Please, take under consideration non-sterile production of:
1. Tablets
2. Ointments
3. API (e.g. oil extraction from plants) ]]> IQ (INSTALLATION QUALIFICATION) valtschaq http://www.askaboutvalidation.com/forum/showthread.php?t=3463 http://www.askaboutvalidation.com/forum/showthread.php?t=3462&goto=newpost Thu, 02 Sep 2010 08:16:07 GMT Dear all Pls let me introduce about the concept of SIX SIGMA and how it is useful to pharma manufacturing Nilesh Dear all
Pls let me introduce about the concept of SIX SIGMA and how it is useful to pharma manufacturing
Nilesh ]]> SIX SIGMA FORUM nilesh shete http://www.askaboutvalidation.com/forum/showthread.php?t=3462 http://www.askaboutvalidation.com/forum/showthread.php?t=3461&goto=newpost Wed, 01 Sep 2010 14:55:54 GMT FREE Pharma QA and Validation Testing Training and Placement Validation of Computer Systems New batches start every month!! FREE Training... FREE Pharma QA and Validation Testing Training and Placement
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Who is this course for?
Anyone interested in Validation, Quality, IT, and Business Analysis field for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries.
This course is specifically designed for personnel seeking to enter into computer Systems validation field for pharmaceutical, biotech and medical device industries.



Learning Objectives

The course is designed to provide a thorough understanding of computer system validation. In addition, the course will address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process.
It will also provide a thorough understanding of Computer System Validation Deliverables.



Course Description
Computer Validation – General Overview
Quality Assurance/Manual Testing Basics
Computer Validation fundamentals
Who needs to validate?
What is Computer Validation?
Why is validation necessary and what regulations guide validation requirements?
Review of the computer validation references in 21 CFR Part 11 Regulations.
What is a GxP Regulated System?
Standard Operating Procedures(SOP)
Change Control Management – Change Requests
Testing/QA Basics
What is Testing
Types of Testing
What is a bug/defect
Defect Lifecycle

Computer Validation Process and Deliverables
What is the SDLC (System Development Life Cycle) process?
How does computer validation fit into the SDLC?
How 21 CFR Part 11 applies to computer validation
Validation Plans and Master Validation Plans
User Requirements Specifications
Installation Qualification (IQ)
Operational Qualification (OQ) and Performance Qualification (PQ)
SOPs required for system operation and maintenance
Validation Summary Reports
Traceability Matrix
System Release Memo

What is 21 CFR Part 11?
Background and purpose of Part 11
Overview of Part 11
Review of the Part 11 implications in regulations and guidances:
Discussion of example systems and the evaluation of Part 11 Compliance decisions

Templates and examples will be provided for all Validation Deliverables
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For more info:
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http://futurethoughts.tech.officeliv...VTraining.aspx ]]> SOFTWARE VALIDATION DOCUMENTATION valhelp http://www.askaboutvalidation.com/forum/showthread.php?t=3461 http://www.askaboutvalidation.com/forum/showthread.php?t=3460&goto=newpost Wed, 01 Sep 2010 08:44:04 GMT Hello all, How can I validate a HPLC prep method? In short, the process is like that : DNA oligos are synthesised, then purified on a HPLC... Hello all,

How can I validate a HPLC prep method?

In short, the process is like that : DNA oligos are synthesised, then purified on a HPLC prep, and finally analyzed by the QC.

Our QC, use an analytical HPLC. And the methods are all validated according to ICH guidelines (repeatability, specificity, linearity and accuracy// LOD LOQ are not studied because we don't quantify on HPLC).
I don't think that all of these parameters need to be verified on a HPLC prep method, isn't it?

HPLC prep method validation has to be lighter then analytical method validation.

Sorry for the mistakes,
Best regards ]]> Jean85 http://www.askaboutvalidation.com/forum/showthread.php?t=3460 http://www.askaboutvalidation.com/forum/showthread.php?t=3459&goto=newpost Wed, 01 Sep 2010 04:48:05 GMT Hi, I have validated many GxP systems including lab systems, SCADA, ERP systems etc., Can anyone guide me how to validate an automated identity... Hi,

I have validated many GxP systems including lab systems, SCADA, ERP systems etc., Can anyone guide me how to validate an automated identity and access management system. How do I ensure that my Identity and access management systems is compliant?

I believe this is not a GxP system but a single sign on may give access to different GxP applications.

Any help in this space is highly appreciated. ]]> 21 CFR PART 11 shan_amudha http://www.askaboutvalidation.com/forum/showthread.php?t=3459 http://www.askaboutvalidation.com/forum/showthread.php?t=3458&goto=newpost Tue, 31 Aug 2010 18:53:47 GMT Hello, Do we require cleaning in between two lots of same product or we can go ahead without cleaning? As product has same formulations there is... Hello,

Do we require cleaning in between two lots of same product or we can go ahead without cleaning? As product has same formulations there is no variation in components except two different lots.

Is there anything on FDA website about strictly following any guideline about this issue? ]]> CLEANING VALIDATION centenary http://www.askaboutvalidation.com/forum/showthread.php?t=3458 http://www.askaboutvalidation.com/forum/showthread.php?t=3457&goto=newpost Tue, 31 Aug 2010 11:33:16 GMT Hi all, Does anyone know of any UK (MHRA) or European (EMEA) regulation which is similar to or equivalent of 21CFR Part 11? Presently our... Hi all,

Does anyone know of any UK (MHRA) or European (EMEA) regulation which is similar to or equivalent of 21CFR Part 11?

Presently our company takes a blanket approach to RERS, applying 21CFR Part 11 to all systems which fall within its scope - I'm of the opinion that a lot of effort could be saved not performing assessments/remedial actions upon systems which aren't used in the manufacture of product for FDA regulated markets.

Any opinions? ]]> 21 CFR PART 11 Validation Monkey http://www.askaboutvalidation.com/forum/showthread.php?t=3457 http://www.askaboutvalidation.com/forum/showthread.php?t=3455&goto=newpost Mon, 30 Aug 2010 08:01:33 GMT Validation is a concept that has been evolving continuously since its first formal appearance in United States in 1978. The concept of validation has... Validation is a concept that has been evolving continuously since its first formal appearance in United States in 1978. The concept of validation has expanded through the years to encompass a wide range of activities which should take place at the conclusion of product development and at the beginning of commercial production. Validation is confirmation by examination and provision of objective evidence that the particular requirements for a specified intended use are fulfilled.

Click here to read the entire article. ]]> GENERAL DISCUSSIONS gokeeffe http://www.askaboutvalidation.com/forum/showthread.php?t=3455 http://www.askaboutvalidation.com/forum/showthread.php?t=3454&goto=newpost Mon, 30 Aug 2010 06:13:55 GMT Hi All, just to see how is the sampling plan for consignments of API also finished products for Sterile? please give me any topics or SOP for... Hi All,

just to see how is the sampling plan for consignments of API also finished products for Sterile?

please give me any topics or SOP for sampling plan of Sterilre ..........

Thanks All.... ]]> GVP - GOOD VALIDATION PRACTICE jack http://www.askaboutvalidation.com/forum/showthread.php?t=3454 http://www.askaboutvalidation.com/forum/showthread.php?t=3449&goto=newpost Sun, 29 Aug 2010 12:55:36 GMT :confused: Dear Friends, Our facility does not comply as per GMP requirements (15 years old). In controlled area particle count(PC) is... :confused:
Dear Friends,

Our facility does not comply as per GMP requirements (15 years old). In controlled area particle count(PC) is monitored daily (reason unknown), but as per ISO, PC is monitored either 06 or 12 months once.Sometime the count in certain location cross the action limit.
1) In this case whether it will be addressed as Incidence or OOS (When does
not complies the limit).
2) Since facility does not comply to GMP requirement is it mandatory to
record PC on daily basis?
Can any one suggest the possible corrective action which can be addressed for this issue.

Thanks
Sowmya ]]> GMP - GOOD MANUFACTURING PRACTICE sowmya http://www.askaboutvalidation.com/forum/showthread.php?t=3449 http://www.askaboutvalidation.com/forum/showthread.php?t=3448&goto=newpost Sun, 29 Aug 2010 05:15:25 GMT Hi All, just to see how is the sampling plan for consignments of API also finished products for Sterile? please give me any topics or SOP for... Hi All,

just to see how is the sampling plan for consignments of API also finished products for Sterile?

please give me any topics or SOP for sampling plan of Sterilre ..........

Thanks All.... ]]> GMP - GOOD MANUFACTURING PRACTICE jack http://www.askaboutvalidation.com/forum/showthread.php?t=3448