by maheshbhuva | Oct 23, 2026 | Analytical Chemistry, Pharmacopea
Pharmaceutical water—whether Purified Water (PW) or Water for Injection (WFI)—remains one of the most heavily scrutinized critical utilities during regulatory inspections.With ongoing harmonization across USP <1231>, Ph. Eur., and IP, reviewing analytical data... by maheshbhuva | Oct 2, 2026 | Analytical Chemistry, Pharmacopea, Quality control (QC)
Answer: A PQS establishes a state of control across the four product lifecycle stages (Development, Technology Transfer, Commercial Manufacturing, and Product Discontinuation). The four core enablers and management pillars are: Process Performance and Product Quality... by maheshbhuva | Sep 23, 2026 | Analytical Chemistry, Pharmacopea
ICH Q9(R1) is the revised guideline on Quality Risk Management (QRM) adopted by the International Council for Harmonisation (ICH) to improve how the pharmaceutical industry applies risk management principles throughout the product lifecycle. While the fundamental core... by maheshbhuva | Jun 1, 2026 | Analytical Chemistry, Pharmacopea
These updates are quite significant because they reshape compliance expectations across different regions and therapeutic areas. Let me break down where the impact is most pronounced:🌍 Key Pharmacopoeia Updates- Indian Pharmacopoeia 2026 – 121 new...