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GMP's Certification Audit - Process Control

PROCESS CONTROL

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#1 scoot915

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Posted 22 May 2015 - 04:25 AM

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.

 

 

 

 


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#2 mgourley

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Posted 22 May 2015 - 08:48 AM

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


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#3 scoot915

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Posted 22 May 2015 - 03:18 PM

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 !


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#4 mgourley

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Posted 22 May 2015 - 06:17 PM

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


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#5 Ahmad.raza

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Posted 09 June 2015 - 03:13 PM

Hey scoot
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



Sent from my iPhone using Tapatalk


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#6 mrickard

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Posted 16 June 2015 - 12:49 PM

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.


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