GMP's Certification Audit - Process Control
Hello
Getting ready for GMP's Cert. Audit for Bakery . Need some help with Process Control. Am not sure I understand exactly what they are asking for.
From the expectations manual, I think they want the process steps for each product produced including: documented process targets for the measurable elements regarding quality and meeting specifications, control of formulations, specific points in production that are crucial to quality of finished product.
i interpret that to mean ( very rough draft for Frozen Bagels):
Rec & Storage of ingredients and packaging materials - documented
Mix ingredients - how & documented (control formulations)
Mix dough
Chunker
Divider- weight check - documented (specification/quality control)
Former - belt speed - documented (spec/quality control)
Blast Freezer - temp - documented (spec/quality control)
Finished Product - visual insp- documented (spec/quality control)
Packing - weight - documented (spec control)
Storage - temp - documented (spec/quality control)
This is very rough draft and I may have left steps out or have them out of order. Am I on the right track????
Thanks for any help.
You should probably also list controls that are in place to ensure the product is packed into the correct packaging and that information on any packaging/labels are correct.
Marshall
Thanks for your reply Marshall
I will add the steps you recommended.
After reading several different examples/models online, I started to over think and thought I had misunderstood what they are looking for.
Thanks again !
If you have any allergens that are not common to all products, you should also list those and have procedures in place to prevent cross contamination.
If that's the case, you should of course have a full blown allergen management program.
Marshall
Well documeted, but have u done documeted records for hygiene protols and trend analysis for that,?
And any GMPs relevant to CCPs?
Consider it for GMPs audit
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You're on the right track. Simply put, they want you to develop, conduct, control, and monitor your production processes to ensure your products meet specifications.