SUPAC-GUIDELINES FOR POST-APPROVAL CHANGES

SUPAC (Scale-up and Post-approval Changes) is an important guidelines document that helps pharmaceutical manufacturers carry out safe and effective changes after a product has been approved. This article will provide you with the necessary information about SUPAC.

FDA has issued several guidelines for different dosage forms:

• SUPAC-IR (Immediate Release solid oral dosage form): Apply to immediate release solid oral dosage forms
• SUPAC-MR (Modified Release solid oral dosage form): Apply to Modified release solid oral dosage forms
• SUPAC-SS (Non-Sterile Semisolid dosage): Applicable to semi-solid dosage forms including creams, ointments, gels, etc.

Determining the Type of Change Under SUPAC Regulations

It is important to determine the type of change that requires SUPAC regulation. It may include changes in formulation composition, manufacturing location, manufacturing scale, equipment, and processes. Based on the impact of the change on product quality, SUPAC identifies different levels of change in drug quality, including:

• Minor change (Level 1): No significant impact.
• Moderate change (Level 2): ​​Potentially significant impact.
• Major change (Level 3): Significant impact.

Each level requires different testing criteria and documentation.

Implementing Change Management according to SUPAC

After determining a change, the next step is to implement change management, which includes the following:

1. Providing detailed documentation of the proposed change and assessing the potential impact.
2. Performing necessary stability testing to demonstrate the impact of the change on product quality characteristics.
3. Prepare registration dossier and supporting data to justify the change.

Quality by Design (QbD) Application in SUPAC

In addition to traditional SUPAC implementation, Quality by Design (QbD) will help optimize the manufacturing process and ensure stable product quality even when there are changes after approval.

For example, when changing batch size to larger than 10 times the original batch size, the traditional SUPAC method will require additional stability data and dissolution comparison. However, with QbD, if the change is within the approved design space (DoE) and controlled by process analytical technologies (PAT), no notification is required only internal documentation via PQS. This will improve efficiency and reliability in pharmaceutical manufacturing.

Conclusion

By understanding and following the SUPAC guidelines, companies can effectively implement necessary changes while maintaining the safety and quality of their pharmaceutical products for patients.

Do you have any questions? Please share them in the comments!

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References:

• Navigating SUPAC Changes: A Guide for Pharmaceutical
• Best Practices for the Development, Scaleup, and Post-approval Change Control of IR and MR Dosage Forms in the Current Quality-by-Design Paradigm (2014)
• Scale-up and Postapproval Changes (SUPAC) Guidelines for Industry: A Comprehensive Review (2024)