Alternate Source of Glibenclamide

(for Euglucon 5mg Tablet)

Group 2

Background
Glibenclamide, also known as glyburide, is an antidiabetic

drug in a class of medications known as sulfonylureas. It is a white to almost white, odorless to almost odorless crystalline powder. The active pharmaceutical ingredient of Euglocon 5mg tablet.

Proposal
An

additional source of Gliblenclamide proposed by Roche Philippines Inc.

has

been

Existing Source: Roche Diagnostics Proposed New Source: Dipharma Francis, Italy

Risk Assessment

Risk Identification
1. Material Comparative Analysis The characteristics of the new material obtained through analysis tests is compared to that of the material from the old source.

2. Formulation of the product

Table 1. Composition of Euglocon 5mg tablet

Raw Material Gliblenclamide

Composition per tablet 5.00 mg

Lactose D80
Corn Starch Partially Hydrolyzed Starch Talcum Powder CAB-O-SIL Magnesium Stearate

79.00 mg
65.500 mg 5.00 mg 3.00 mg 2.00 mg 0.500 mg

3. Manufacturing Process Glibenclamide is added during the wet granulation stage of the manufacturing process.

Risk Analysis
1. Material Comparative Analysis Test results of the new material are compared to the existing specifications. The differences of the results and its probable impact on the SISPQE of the product are identified.

2. Formulation of the product No change in the formulation. 3. Manufacturing process

No change in the process.

Risk Evaluation
Severity
The material may have an negative impact on the product assay. Failure to meet specifications may cause an adverse effect on the product user and non-compliance with the regulatory requirements.

Occurence

Test results of Glibenclamide Assay from both sources.

Stability profile of the product

Detectability

Determined based on the tests conducted

The identified worst case impact was the probable effect on the product stability. Thus, stability studies may provide information on the actual impact of the difference in specification of the old and new material.

Risk Control

Conduct Process Validation for the manufacturing operation of Euglocon 5mg Tablet

Risk Review

Conduct Revalidation