Tips to avoid Deficiency Letter

Table of Content

• Deficiency letters
• Tips to avoid deficiency letters
  • Tip -1: Effective document review
  • Tip -2: Impurity specifications should be based on rational approach and not on the ideological approach
  • Tip – 3: Implementation on lesson learning approach
• Conclusion

Introduction and Outcome; Tips to avoid Deficiency Letter

Avoiding deficiency letters is a challenging task for any Pharmaceutical industry. The Regulatory Department coordinates this work with the support of various other departments, such as Analytical Research, Synthetic Research, Quality Control, and Quality Assurance. The biggest challenge for these industries is to minimize the number of deficiency letters they receive. This article shares three secret tips to help minimize deficiency letters, making you capable of handling these letters effectively.

Tips to Avoid Deficiency Letters

Tip -1: Effective document review

Generally, DLs are given on documents related to Analytical Research, Synthetic research, Quality Control, Quality Assurance and Regulatory Affairs. There must be an expert team in each department for review of their corresponding document prior to DMF filing. It will minimize several Deficiency letters related to typographical error, Structure error of the molecule, and Calculation error.

Case study:

Typical DL; You are requested to include IR or UV in the identification test.

Tip -2: Impurity specifications should be based on rational approach and not on the ideological approach

Deficiency letters on specifications like Related substances specifications and assay specifications are given by all the Regulatory agencies and such unnecessary Deficiency letters can be avoided .

Case study:

Let us consider the limit of an unknown impurity is 0.50%. Any regulatory agency give DL on it.

Impurity specification must be kept based on trend data of several lots with a rational justification. As ICH guideline limit of unknown impurity should be less than or equal to 0.10%. For higher limit impurity must be identified and kept under specified impurity.

Tip – 3: Implementation on lesson learning approach

It has been observed that most of the deficiency letters are common and the same are asked by different Regulatory agencies. Such deficiency letters can be avoided. Deficiency letters data bank should be prepared by the organizations and knowledge of these Deficiency letters should be implemented in new Active pharmaceutical ingredients before submitting the DMF.

Case study

Suppose for an API only one identification test (by HPLC) is kept in the specification. Hence any Regulatory agencies can ask the question on it because two identification tests are required. One identification test should be by chromatographic technique and the second identification test should be preferably by spectroscopic techniques like UV and FTIR. Chemical tests can also be accepted for second identification test.

Conclusion

Hope this post has enhanced your knowledge of deficiency letter and you can use these tips to minimise the deficiency letters. Write you suggestion/question related to this post in the comment section

Abbreviations

• DL: Deficiency letters
• DMF: Drug Master File
• UV: Ultraviolet spectroscopy
• IR: Infrared spectroscopy
• API: Active pharmaceutical ingredient