???? ♂?? ♀?From the Users Point of View: Variations Case Study???

Introduction

*All information included in the drug product dossier is considered part of the MA.

*Therefore introducing any change to this DP may have a major impact on the product registrations in the respective countries and will require careful planning and coordination before, during and after implementation of this variation.

*RA plays a major role in coordinating the internal and external parties (Company departments & HA) to make sure the implementation of the change is done in compliance with the registered data.

Q: What is a variation?

Q: What Types of variations exist?

Q: Variation process from RA perspective?

Q: Define the scope of the variation

It is important to evaluate all parameters of the variation:

• What exactly needs to be changed?
• Which documentation is affected?
• Where should the change be submitted?
• What additional regulatory submissions can be considered?
• Should only the planned change be submitted? ,or additional changes to update the registration to the current status have to be included?

Q: Planning & Collection of documentations status?

Regulatory requirements in different countries are not identical

“The documentation considered sufficient for a certain variation in one country,

might not lead to approval of the same change in another country”

Examples of variable items:

• Certificates (CPP, GMP, DMF LOA,TSE)
• Authentication “Legalization/Notarization/Apostillation”
• Translations
• Raw data “HPLC Chromatograms”
• Samples & reference standards

Q: Planning of resources?

• Internal resources
• External resources “Consultants”
• Budget and fees

Planning: Compilation of variation documentation

• Submission timetable
• Data collection for submission

Example: Case Study #2

Business Background:

• Your DP batch size isn’t satisfactory to cover the market demand. Also, you would like to add a QC testing site B of the DP, as to overcome the delay of obtaining the QC results from QC site A.
• You would like to scaleup the DP batch size and add the QC testing site B.
• How is the change of batch size scale and addition of QC testing site B implemented correctly?

New Regulatory Task / Activity: “Variation”

• Change of batch size scale and addition of QC testing site
• New sequence in eCTD dossier is required to indicate this new change

Case Study 2: Change in batch size scale of DP & addition of QC testing site for DP

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What mandatory conditions and criteria must be met before starting?

● Conditions of Change in batch size scale of DP:

1)The change does not affect reproducibility and/or consistency of the product.

2)The change should not be the result of unexpected events arising during manufacture or because of stability concerns.

● Conditions of Replacement or addition of quality control testing site of the DP:

1)The site is appropriately authorized.

2)Method transfer from the old to the new site or new test laboratory has been successfully completed.

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