Slide 1Good Manufacturing Practice (GMP) Compliance: GMPs EXPLAINED Presented by Raymond A. Bonner Nathan C. Sheers SIDLEY AUSTIN BROWN & WOOD, LLP Washington, D.C. (202)…

1. Definitions A vaccine is a product intended to stimulate the immune system in the prevention, amelioration or treatment of disease or infection. A vaccine may be a live…

7. Equipment and Calibration INTRODUCTION EQUIPMENT GMP CONTROLS      Maintenance      Records MANUFACTURING MATERIALS      Analyze Use      Control Use…

Slide 1 Quality Control Is that part of GMP concerned with: sampling, specification & testing, documentation & release procedures which ensure that the necessary…

Slide 1 Introduction to Equipment Issues Slide 2 Each manufacturer should assure that production equipment and quality control measurement equipment, including mechanical,…

IPQC: Definition:- Checks performed during production in order to monitor and, if necessary, to adjust the process to ensure that the product conforms to its specifications.…

IPQC: Definition:- Checks performed during production in order to monitor and, if necessary, to adjust the process to ensure that the product conforms to its specifications.…

Contents Drinking Water ................................................3 General References ..........................................6 Ground Water ..................................................8…

EXCEPTION REPORTS: INVESTIGATING AND DOCUMENTING EXCEPTION EVENTS April 14, 2015 G Habiger Consulting, LLC Exception Events (investigations/deviations/CAPAs) represent the…

Good Manufacturing Practices (âGMPsâ) Good Manufacturing Practice Good Manufacturing Practice Regulations Establishes minimum GMP for methods to be used, and the facilities…