Pharma Broadcast’s Post

ICH Q3C(R9): GUIDELINE FOR RESIDUAL SOLVENTS The update: Adoption of Minor revision to section 3.4. including consideration of solvent volatility for analytical methods, (section 3.4., page 4) by the Regulatory Members of the ICH Assembly under Step 4 .

DRL 483 OBSERVATION ANALYSIS: 1. Analytical method validated letter, however Comercial batches production continue. As proactive approach, once method is validated, impact assessment not performed for already released batches to meet requirement of established criteria. For the product which is within self-life and distributed in market. Refer attached screenshot.

𝐖𝐡𝐚𝐭 𝐢𝐬 𝐭𝐡𝐞 𝐝𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐜𝐞𝐬 𝐛𝐞𝐭𝐰𝐞𝐞𝐧 𝐂𝐫𝐢𝐭𝐢𝐜𝐚𝐥 𝐩𝐫𝐨𝐜𝐞𝐬𝐬 𝐩𝐚𝐫𝐚𝐦𝐞𝐭𝐞𝐫 (𝐂𝐏𝐏) & 𝐂𝐫𝐢𝐭𝐢𝐜𝐚𝐥 𝐪𝐮𝐚𝐥𝐢𝐭𝐲 𝐚𝐭𝐭𝐫𝐢𝐛𝐮𝐭𝐞 (𝐂𝐐𝐀) ? • 𝐂𝐫𝐢𝐭𝐢𝐜𝐚𝐥 𝐩𝐫𝐨𝐜𝐞𝐬𝐬 𝐩𝐚𝐫𝐚𝐦𝐞𝐭𝐞𝐫 (𝐂𝐏𝐏): A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality. (Ex: Temperature, Humidity, Time,...etc.) • 𝐂𝐫𝐢𝐭𝐢𝐜𝐚𝐥 𝐪𝐮𝐚𝐥𝐢𝐭𝐲 𝐚𝐭𝐭𝐫𝐢𝐛𝐮𝐭𝐞 (𝐂𝐐𝐀): A physical, chemical, biological or microbiological property or characteristic that should be within an approved limit, range or distribution to ensure the desired product quality. (Ex: Homogeneity, Assay, Volume, Weight, Appearance...etc.)

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Standard Sharpe is meaningless without proper statistical validation..

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