QC Function

• QC Function


  Responsible for the day-to-day control of quality in a company
• Responsible for the day-to-day control of quality in a company:

  • Analytical testing of incoming raw materials
  • Inspection of packaging and labeling components
  • Conduct in-process testing where required
  • Perform environmental monitoring
  • Inspect operations for compliance
  • Conduct required test on the final product
• Analytical laboratory testing of products

  Staff/analyst, Equipment and Instrumentation
• Trained academically and is capable of performing complex analysis

  Staff or analyst
• Suitable for performing the testing in an accurate and efficient manner

  Equipment and Instrumentation
• Detailed specifications and validated test methods must be available
• The specifications details the limit for acceptance (or rejection) based on identified critical parameters
• Select qualified vendors from whom materials are purchased
• Packaging and labeling components must be inspected and tested against rigid specifications to assure that they meet predetermined functional standards.
• Labeling in the most critical component
• Sample and test products at various critical steps in production against criteria previously established
• In-process alert or action levels are identified as a means of process control; are more restrictive than the final acceptance limit; provides early warning of conditions which could lead to an out of control situations.
• Materials which have an alert level criteria are still acceptable since they have not exceeded an out-of-control limit.
• Distribution departments are responsible for controlling the shipping and handling of products using inventory control systems based on the First in, First out principle
• They select modes of distribution that will protect products from adverse handling or environmental conditions while in transit distribution points and to customer
• Assures the quality and stability of the product by preventing the products from being exposed to a hostile environment.

  Monitoring of Environmental Conditions
• Parenteral and Ophthalmic products must be produced in a controlled environment designed to protect their sterility.

  For Sterile product
• Monitoring of air and water systems

  For Sterile products
• Liquids, tablets, capsules - must be manufactured under strict but acceptable limits of particulate and microbial matters

  For Non-sterile products