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gmp complaint handling system
Posted on May 15, 2023May 13, 2023
Have you established an adequate complaint handling system?

A complaint handling system is a procedure for receiving, reviewing and evaluating complaints in a […]

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  • by Dina Kisver
  • 0
supplier approval program
Posted on May 1, 2023April 28, 2023
Are you following your supplier approval program?

According to the Code of Federal Regulations (CFR) section 21 CFR 820.50, each manufacturer shall […]

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  • by Dina Kisver
  • 0
following written procedures
Posted on April 14, 2023April 14, 2023
Are you following your written procedures?

Written procedures are the corner stone of any GMP manufacturing facility.  Procedures are written to […]

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  • by Dina Kisver
  • 0
reviewing audit trails
Posted on March 31, 2023March 30, 2023
Are you reviewing your audit trails?

The Code of Federal Regulations (21 CFR 211.194 Laboratory Records), states that laboratory records must […]

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  • by Dina Kisver
  • 0
stability data for expiration dates
Posted on March 15, 2023March 15, 2023
Do you have sufficient stability data to support your expiration date?

ICH guideline Q1A(R2), states that “the purpose of stability testing is to provide evidence on […]

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  • by Dina Kisver
  • 0
analyst-is-drawing-sample-from-dissolution-test-of-2022-11-09-02-59-36-utc
Posted on March 1, 2023March 8, 2023
Are you performing an effective line clearance before packaging product?

Line clearance is an integral part of every facility’s standard operating procedure in order to […]

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  • by Dina Kisver
  • 0
designated areas to prevent contamination
Posted on February 15, 2023February 14, 2023
Do you have separate or defined areas to prevent contamination or mix-ups of materials?

According to the Code of Federal Regulations (21 CFR 211.42 Design and Construction Features), any […]

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  • by Dina Kisver
  • 0
Performing CAPA effectiveness checks
Posted on February 1, 2023January 30, 2023
Are you performing your CAPA effectiveness checks?

A company recently received the following observation regarding CAPA: …. Procedures for corrective and preventive […]

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  • by Dina Kisver
  • 0
Forming a quality strategy for 2023
Posted on January 16, 2023June 30, 2023
Quality Strategy for 2023

January is a time when all facilities should revisit their quality strategy, and adjust it […]

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  • by Dina Kisver
  • 0
gmp trends - fda 483 compliance
Posted on January 2, 2023July 5, 2023
Happy New Year from GMP Trends!!

Happy New Year! Let 2023 be full of adventure and growth. To help you prepare […]

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  • by Dina Kisver
  • 0

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