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BASIC REQUIREMENTS FOR QC

Submitted by pratyesh on Wed, 04/30/2008 - 13:39.

in

MyBlog

Keywords: QC, materials, records

A. Adequate facilities
• Trained personnel
• Approved procedures for Sampling
• Inspecting
• Testing starting materials
• Testing packaging materials
• Testing intermediates
• Testing bulk and finished products
• Monitor environmental conditions

B. Sampling:
• Samples must be taken by methods and personnel approved by QC
• Samples of starting materials, packaging material, intermediate products, bulk products and finished products

C. Validated methods:
• Test methods must be validated

D. Records
• Records must be made manually or by recording instruments showing and procedures followed and deviation recorded and investigated

pratyesh's blog
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