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It’s useful to understand the trends of FDA citations. Satisfying the CFRs remains a challenge; the awareness, experience, and tools used for compliance are (and should be) evolving. Reviewing the deficiencies as a checklist can prove a first step toward better coverage, as it can reveal needed internal actions. A recent listing of citations by category has yielded a top ten for the drug industry over a recent four-year period (2018-2022).

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We at InstantGMP have uniquely designed documentation software based on the CFRs. Initially, our objective was to link Electronic Batch Records with Inventory Management. This addresses at least 5 of the above categories:

  • 21 CFR 211.192 Production Record Review
  • 21 CFR 211.160(b) Material Appropriate Specifications and Test Procedures
  • 21 CFR 211.100(a) Process Control Procedures for Assuring Material Attributes (Identity, Purity, Strength, and Quality)
  • 21 CFR 211.68(b) Changes in Production Procedures Only Allowed by Authorized Personnel
  • 21 CFR 211.110(a) In-Process Tests for Batch Uniformity and Integrity

Then, we added Equipment and Room logs, a full EQMS and EDMS, as well as enhancements and configuration tools, rounding out the design of our highly integrated PRO.  These address the remainder of the list.

We’ve reviewed this analysis and believe the PRO system, when properly used, will prevent the full range of the deficiency causes shown here. Additionally, PRO automates the process through 21 CFR Part 11 and other points of compliance to add efficiency to the documentation and operation processes. How is this possible? We’ve designed the workflows to be coordinated, which can save time.

WHY THIS IS IMPORTANT

Many firms in all regulated domains are getting by by using multiple systems (including manual) to cover these areas. This is especially true for Electronic Batch Records and Inventory Management. We have found through our own customer inquiries that these two key operations are frequently not coordinated. And for the range of GMP processes overall, disparate systems can cause human error and other problems throughout the enterprise.

PRO and our hands-on support team can improve your regulated production, inventory, quality, document control, and equipment and facilities management in a real-time, optimal way.

Work with us…and you will drastically reduce your odds for these citations…and having to deal with them. www.instantgmp.com

 

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