Author Topic: Validation parameters for equipment  (Read 1000 times)

viraggophane

  • Newbie
  • *
  • Posts: 1
  • City: vadodara
  • Organisation: Parul Institute of Pharmacy and Research
Validation parameters for equipment
« on: July 31, 2012, 08:47:14 AM »
Dear forum members,

What are the ideal parameters for validation of equipment such as UV spectrophotometer, HPLC and Dissolution Apparatus.?
« Last Edit: July 31, 2012, 09:03:30 AM by PharmWeb »
Thank you in advance.

Regards
Virag Gophane
QA department
PIPR, Vadodara

mike313!

  • Newbie
  • *
  • Posts: 1
  • City: Deerfield
Re: Validation parameters for equipment
« Reply #1 on: August 02, 2012, 07:05:44 PM »
You will find valuable hints on how to validate laboratory equipment in the USP under General Chapters - these chapters include a chapter on Chromatography, and another on Spectroscopy.

FrankBales

  • Newbie
  • *
  • Posts: 2
  • City: Scranton, PA
  • Organisation: Bales Pharma Consulting LLC
Re: Validation parameters for equipment
« Reply #2 on: August 05, 2012, 01:54:26 AM »
The terminology applied to equipment is “Qualification”; the terminology applied to methods is “Validation”
The validation literature for methods using HPLC is deep, and central is ICH Q2 (R1) :
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf.
The Reviewer Guidance Validation of Chromatographic Methods provides information on this and other techniques:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM134409.pdf
For Equipment Qualification, a good starting reference is USP General Chapter <1058> Analytical Instrument Qualification. This chapter is not mandatory, as is indicated by the chapter number being greater than 1000. When applied to existing or used equipment, this approach probably leads to ensuring that the equipment is as intended when it was new, so the manufacturer should be contacted for specific information. A good general document on UV-VIS, (that provides further references), is
http://blpd.dss.go.th/knowledge_el/VAM_UV_VIS_umaporn.pdf
 

bharatbuk

  • Newbie
  • *
  • Posts: 32
  • City: mumbai
  • Organisation: Bharat Book Bureau
Re: Validation parameters for equipment
« Reply #3 on: October 18, 2012, 01:08:35 PM »
A manufacture can assure through careful validation and design processes,process controls,that there is high probability that all manufactured will meet specification..basic principle of validation include to establish that the process equipment has the capability of operating within required parameters.
FrankBales has provided three major article which helps to understand detail information about validation of analytical procedure,validation of chromatographic process,validation for spectrometer.I just bookmark these three article,really helps for growing my knowledge..Thanks for sharing

 


Search the V1 and V2 PharmWeb Discussion Forum Archive

Loading