FDA Requirements regarding Quality Assurance

Many of the requirements laid down in the US-American GMP regulations (21 CFR 210/211) are not very specific. However, they are concretized among other things by Guidances - and by Warning Letters. Warning Letters in particular show very clearly how the FDA interprets its GMP regulations. A current Warning Letter provides information on the tasks of the Quality Assurance Unit.

In a current Warning Letter dated January 22, 2021, the FDA criticised deficiencies in the Quality Assurance Unit of a Chinese manufacturer of over-the-counter (OTC) medicinal products.

In particular, the FDA criticised the lack of written procedures regarding the responsibilities of the Quality Unit with respect to:

  • Batch Record Review  
  • Supplier qualification
  • Equipment qualification
  • Calibration
  • Process validation
  • Cleaning Validation
  • Annual Product Review

An action plan for correcting the deficiencies should demonstrate that the procedural instructions in the company are suitable and "sound". Measures are to be taken to ensure that the Quality Assurance Unit can apply its "Quality Oversight" broadly. In particular, investigations and, if necessary, sorting of goods with regard to identity, strength, quality and purity are addressed as tasks of the Quality Assurance Unit.

Furthermore, the FDA criticised that no tests were carried out on the starting materials and end products with regard to identity and content. Lack of stability data confirming the shelf life of the products was also complained about.

All of this resulted in a clear reference to FDA's Guidance "Quality System Approach to Pharmaceutical CGMP Regulations." The FDA also recommends engaging a consultant, taking into account the requirements of 21 CFR 211.34. This consultant should first conduct an audit of all GMP-relevant activities and check the implementation and effectiveness of the CAPA measures based on the Warning Letter. Only after that the company should contact the FDA again. The Warning Letter expressly emphasizes that Senior Management is responsible for remedying the deficiencies.

Conclusion: In this Warning Letter, the FDA provides very clear information about the comprehensive tasks of a Quality Assurance Unit - including a "Quality Oversight" - in accordance with the US GMP regulations.

Please see the complete FDA Warning Letter to Yuyao YiJia Daily Chemical Co. for more detailed information.

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