ICH Q1 Guideline: Stability Testing of New Drug Substances and Drug Products – A Complete Pharmaceutical QA Guide
Introduction to ICH Q1 Stability Testing Stability testing is one of the most critical aspects of pharmaceutical QA/QC and regulatory affairs. It is an important tool providing scientific proof of the changing quality of drug substances and/or finished pharmaceutical products as a result of exposure to environmental factors such as temperature, humidity, and light. Guidelines for stability have been developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in order to provide scientifically sound retest intervals, shelf life, and storage conditions recommendations. Traditionally, the ICH Q1A(R2): Stability Testing of New Drug Substances and…
Bangladesh Pharmaceutical Market 2026: Top 30 Pharma Companies by IQVIA MAT Q2
Bangladesh’s pharmaceutical industry continues to experience strong market growth in 2026, with the total pharmaceutical market reaching BDT 40,885 crore according to the provided IQVIA MAT Q2 2026 data. The market recorded 10.6% growth, while the four-year compound annual growth rate (CAGR) stood at 11.4%. The latest Bangladesh pharma market ranking demonstrates the strength of established pharmaceutical manufacturers while also showing significant growth among several emerging and mid-sized companies. This analysis presents the top 30 pharmaceutical companies in Bangladesh, including their market value, market share, growth rate and four-year CAGR. Bangladesh Pharmaceutical Market at a Glance The Bangladesh pharmaceutical market…
FDA Cracks Down on Amazon and Global Drug Manufacturers Over Unapproved Products and Serious CGMP Violations
FDA Issues Multiple Warning Letters Targeting Online Retailers and Pharmaceutical Manufacturers The FDA has upped its game with increased enforcement action by releasing a number of warning letters to online retailers and drug manufacturers for their non-compliance with CGMPs and unauthorized drug promotion. This move shows that the FDA is putting more emphasis on patient safety, product quality, data integrity, and regulatory compliance in the international pharmaceutical supply chain. Some of the pharmaceutical companies to receive FDA warning letters include the online retailing behemoth Amazon, South Korean pharmaceutical manufacturer Huons, and Canadian sterile drug manufacturer Jubilant HollisterStier. There were several…