Pharma Guidelines Novel Medical Drug Research Pharmaceutical Manufacturing Guidelines

Pharmaceutical Manufacturing Guidelines Latest Updates Novel Medical Drug Research Information on latest Quality Assurance Systems Pharmaceutical Technology Research and Developments FDA updates

Custom Search

Saturday, September 20, 2008

auto calibration acceptable weighing balance in Pharma manufacturing

1. Many leading analytical balance manufacturers provide built-in "auto calibration" features in their balances. Are such auto-calibration procedures acceptable instead of external performance checks? If not, then what should the schedule for calibration be?
The auto-calibration feature of a balance may not be relied upon to the exclusion of an external performance check (211.68). For a scale with a built-in auto-calibrator, we recommend that external performance checks be performed on a periodic basis, but less frequently as compared to a scale without this feature. The frequency of performance checks depends on the frequency of use of the scale and the criticality and tolerance of the process or analytical step. Note that all batches of a product manufactured between two successive verification would be affected should the check of the auto-calibrator reveal a problem. Additionally, the calibration of an auto-calibrator should be periodically verified--a common frequency is once a year--using National Institute of Standards and Technology (NIST)-traceable standards or NIST-accredited standards in use in other countries.

Keep reading this blog for cGMP and WHO GMP requirements SOP Validations Master Manufacturing documents sample Change control procedure and format water purification system and its validations cleaning validations ,personnel hygiene and guidelines for gmp microbiological procedure SOPS and manufacturing procedures for pharmaceutical dosage forms Master validation plan sample copy and for your WHO GMP requirements
good manufacturing practice guide for pharmaceuticals manufacturing
Quality assuarance guide for pharmaceuticals manufacturing
Q.A guide for pharma
Email this blog to your friends or collegues who are working in a pharmaceutical manufacturing firm
good manufacturing practice guide for pharmaceuticals manufacturing
Pharmaceuticals manufacturing guide for good manufacturing practice and validations
-------------------------------------------------------------------------------------------------
To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies

No comments:

Subscribe to RSS headline updates from:

Contact Form

Name

Email *

Message *