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Posted on January 15, 2021January 13, 2021
Are you ready for an FDA inspection in 2021?

Don’t become complacent.  Be ready for your next FDA Inspection. Find out the top cited […]

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  • by Dina Kisver
  • 0
Posted on January 1, 2021December 28, 2020
Are you ready for the new year?

Starting off a new year can be daunting.  The best way to alleviate the anxiety […]

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  • by Dina Kisver
  • 0
Posted on December 15, 2020December 14, 2020
Have you established Quality Agreements with your suppliers?

A company recently received this 483 observation: ….. There is no agreement with suppliers, contractors […]

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  • by Dina Kisver
  • 0
Posted on December 1, 2020November 30, 2020
Can you access your old lab data?

A company recently received this 483 observation: ….. Laboratory records do not include complete data […]

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  • by Dina Kisver
  • 0
Posted on November 16, 2020November 12, 2020
Have you set up appropriate computer controls for your lab equipment?

A company recently received this 483 observation: ….. Appropriate controls are not exercised over computers […]

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  • by Dina Kisver
  • 0
Posted on November 2, 2020October 27, 2020
Are you storing your products properly?

A company recently received this 483 observation: … Drug products are not stored under appropriate […]

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  • by Dina Kisver
  • 0
Posted on October 15, 2020October 27, 2020
Are only the current versions of your SOPs in circulation?

A company recently received this 483 observation: ….. The responsibilities and procedures applicable to the […]

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  • by Dina Kisver
  • 0
Posted on October 1, 2020September 29, 2020
Is your lab personnel recording data on scratch paper?

A company recently received this 483 observation: …. Laboratory records do not include complete data […]

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  • by Dina Kisver
  • 0
Posted on September 15, 2020September 14, 2020
Are you handling your rejected products properly?

A company recently received this 483 observation: …. Written production and process controls procedures are […]

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  • by Dina Kisver
  • 0
Posted on September 1, 2020September 1, 2020
Are you qualifying your suppliers?

A company recently received this 483 observation: ….. The program for evaluating and monitoring supplies […]

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  • by Dina Kisver
  • 0
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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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GMP Trends® was founded because, as quality professionals, we recognized the need for an unbiased editing of all relevant FDA 483's.

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Recent Posts
  • Are you ready for an FDA inspection in 2021?
    January 15, 2021
  • Are you ready for the new year?
    January 1, 2021
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