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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
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, 2023January 12, 2023
Have you planned your 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, 2023January 3, 2023
Happy New Year from GMP Trends!!

Welcome 2023! May this new year be full of adventure and growth. To help you […]

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  • by Dina Kisver
  • 0
calibration program for gmp
Posted on December 15, 2022December 15, 2022
Is your calibration program adequate?

The purpose of equipment and instrument calibrations is to ensure accurate measurements.  The FDA defines […]

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  • by Dina Kisver
  • 0
second person verification in a laboratory
Posted on December 1, 2022November 29, 2022
Do you have a second person verifier?

Second person verification is an essential part of GMP compliance. The job of the second […]

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  • by Dina Kisver
  • 0
Employee training for pharmaceutical GMP
Posted on November 15, 2022November 14, 2022
Are your employees properly trained?

Employee training is a vital part of any robust quality management plan.  GMP Trends Annual […]

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  • by Dina Kisver
  • 0
risk management program
Posted on November 1, 2022October 31, 2022
Do you have a risk management program?

According to 21 CFR 820.30(g), as part of the design validation process, risk analysis must […]

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  • by Dina Kisver
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GMP TRENDS is a publication for the pharmaceutical and medical device industries, trending observations made by FDA investigators during GMP inspections throughout the world.

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Recent Posts
  • Do you have sufficient stability data to support your expiration date?
    March 15, 2023
  • Are you performing an effective line clearance before packaging product?
    March 1, 2023
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