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Posted on May 16, 2022May 16, 2022
Do you have procedures on issuing labels?

According to the Code of Federal Regulations (CFR), 21 CFR 211.125 strict control shall be […]

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  • by Dina Kisver
  • 0
Posted on May 10, 2022May 13, 2022
Cross-Contamination Problems for Emergent BioSolutions

Download the Emergent FDA 483 Report for free using promo code emergent-483 Recently Emergent BioSolutions […]

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  • by Dustin
  • 0
quality unit in a laboratory
Posted on May 2, 2022May 2, 2022
Is your quality unit independent from production?

A company recently received the following observation: ….. The Quality Unit is not involved in […]

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  • by Dina Kisver
  • 0
cleaning validation
Posted on April 26, 2022May 10, 2022
The Intricacies of Cleaning Validation

GMP Trends has seen multiple observations related to cleaning validation cited by the U.S. FDA […]

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  • by John Schleck
  • 0
Posted on April 15, 2022April 15, 2022
Are your complaint investigations adequate?

Do you have sufficient information in your complaint investigations?  Do your investigation reports include conclusions […]

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  • by Dina Kisver
  • 0
management review
Posted on April 1, 2022April 8, 2022
Have you established your management review process?

Management Review is all about reviewing the available data to confirm that adequate resources are […]

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  • by Dina Kisver
  • 0
Posted on March 15, 2022April 8, 2022
Are you following your written stability testing program?

The purpose of stability testing is to provide evidence on how the quality of a […]

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  • by Dina Kisver
  • 0
Posted on March 1, 2022March 1, 2022
Are you maintaining your DHR properly?

According to the Code of Federal Regulations (CFR), the device history record is a compilation […]

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  • by Dina Kisver
  • 0
good documentation practice
Posted on February 15, 2022February 15, 2022
Do you have good documentation practices?

Good Documentation Practices, also known as GDocP, is an important function of Good Manufacturing Practices […]

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  • by Dina Kisver
  • 0
Posted on February 1, 2022January 29, 2022
Have you validated your water system?

Water is a versatile component used in the pharmaceutical industry.  It can be used as […]

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  • by Dina Kisver
  • 0

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Recent Posts
  • Do you have procedures on issuing labels?
    May 16, 2022
  • Cross-Contamination Problems for Emergent BioSolutions
    May 10, 2022
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