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 19, 2026 | Analytical Chemistry, Documents error (DIN), GMP, ICH Guideline, Out of specification, Pharmaceutical interview,, QMS, Quality control (QC)
An Out of Specification (OOS) investigation is a critical regulatory requirement in the pharmaceutical industry. When an analytical result falls outside the established specifications or acceptance criteria (defined in pharmacopoeias, drug applications, or internal...
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 | Feb 11, 2023 | Analytical Chemistry, GMP
â—‹ Whenever supervisor give work allocation for testing any product.â—‹ Then careful read specification(SOP) not missing any point which is defied in sopâ—‹ Before start analysis glassware collect in try â—‹ Labelling of each glassware â—‹ Seen availability chemicals and...
by maheshbhuva | Dec 17, 2022 | GMP
The European Union (EU) Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use – Annex 1, commonly referred to as GMP Annex 1, was originally published as a draft in 2017. This draft left many people operating in the...
