by maheshbhuva | May 25, 2026 | Analytical Chemistry, Analytical method development hplc,, GMP, ICH Guideline, Method validation, process validation, QMS, Quality control (QC)
The pharmaceutical and biotechnology sectors in New South Wales are experiencing an incredible boom. From the bustling research hubs in Macquarie Park and Westmead to the clinical trials happening across Randwick, local innovators are developing next-generation...
by maheshbhuva | May 16, 2026 | Analytical Chemistry, GMP, Quality control (QC)
Duplicate raw material samples is critical for maintaining data integrity, ensuring cGMP compliance, and optimizing laboratory workflow efficiency. Duplicate samples often occur due to manual entry errors, mislabeling, or poor communication between the warehouse...
by maheshbhuva | Apr 29, 2026 | Analytical Chemistry, Quality control (QC), Uncategorized
To optimize a raw material (RM) flow sheet for pharmaceutical compliance, the process must transition from a simple sequence to a data-integrity-focused workflow. In a GxP environment, every step must ensure traceability, prevent cross-contamination, and enforce...
by maheshbhuva | Jan 3, 2026 | 21 CFR, Analytical Chemistry, QMS, Quality control (QC)
Introduction: Cracking the Code The pharmaceutical industry is filled with complex jargon and acronyms that can be intimidating to outsiders and newcomers alike. One term that frequently appears is “21 CFR,” a seemingly cryptic code that holds immense...
by maheshbhuva | May 3, 2025 | Analytical Chemistry, Quality control (QC), stability
Out-of-Trend (OOT) in Pharmaceutical StabilityIn the pharmaceutical industry, Out-of-Trend (OOT) results refer to analytical data obtained during stability studies that, while still within the established specification limits, deviate significantly from the expected...
