by maheshbhuva | Dec 5, 2025 | Analytical Chemistry, Deviation, Quality control (QC)
Detailed Breakdown 1. Deviation Definition: Any departure from a written procedure, standard, or instruction. Types: Planned Deviation: A temporary, pre-approved change. (e.g., “We are out of Filter A, so we have permission to use Filter B for this batch...
by maheshbhuva | Dec 4, 2025 | 21 CFR, Analytical Chemistry, Deviation, ICH Guideline, Quality control (QC)
1. EDQM / EU GMP (Europe) Focus: The European approach places heavy emphasis on the Qualified Person (QP). The QP acts as the gatekeeper and must personally ensure that any deviation does not violate the Marketing Authorization (MA). Risk Management: EU GMP...
by maheshbhuva | Jun 6, 2023 | stability
No Only manufacturing area or production batch taken as stability Share this: Click to share on Facebook (Opens in new window) Facebook Click to email a link to a friend (Opens in new window) Email Click to share on Reddit (Opens in new window) Reddit More Click to...
by maheshbhuva | May 31, 2023 | stability
It’s 60℅ Rh because (100 – 60 = 40 ℅ loss water (100-90 = 10 ℅ loss water Here 100 is in side containers water Inside container concentration might be different but, it’s water remain 100 ℅ Share this: Click to share on Facebook (Opens in new window)...
by maheshbhuva | Apr 9, 2023 | Deviation, Documents error (DIN), QMS
Why investigation? To identified error Random error Impacts precision (Weight error dilution error injection to injection error Example document error, document error [ note : Precision show random error which is not control for us] +- positive and negative error...
