Webinar Preview: Capturing Processes for MBRs

Webinar Preview: Capturing Processes for MBRs

On Tuesday, April 21st, InstantGMP and dietary supplement regulatory expert Marian Boardley present Tips for GMP Compliant Master Batch Records. There’s still time to sign up! We will be sharing common issues with Master Batch Records that lead for 483s and how you can avoid them.

 

MBRs are essentially written instructions for specific manufacturing processes. They need to include step-by-step instructions with specifications, ingredients, equipment lists, verification of cleaning and calibration and proof that a quality team approves each batch.

Before initializing a new MBR, Standard Operating Procedures (SOPs) should be in place and all roles defined. Each department should be consulted on their activities:

  • Step-by-step instructions
  • Identify limits and controls on each step
  • Address all forms and how to handle them
  • Identify simultaneous activities and order them in a way that makes sense
  • The time it takes to complete each step

Capturing the manufacturing process accurately is the first step in maintaining GMP compliant Master Batch Records. Maintaining accurate, GMP compliant MBRs means the manufacturing process is streamlined and errors will be greatly reduced.

Want to learn more? Join us in Tuesday, April 21st!

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