DMF GRADE API MANUFACTURER EXPORTER SUPPLIER SWAPNROOP DRUGS AND PHARMACEUTICALS MAHARASHTRA INDIA

  API Manufacturing Common Mistakes: Lessons for Sustainable Pharmaceutical Quality By SWAPNROOP DRUGS AND PHARMACEUTICALS In pharmaceutical manufacturing, Active Pharmaceutical Ingredients (APIs) are the foundation of drug quality, safety, and efficacy. Even minor errors during API manufacturing can lead to regulatory non-compliance, batch failures, supply disruptions, and patient risk . Understanding common API manufacturing mistakes—and how to prevent them—is essential for building robust, compliant, and scalable operations. At SWAPNROOP DRUGS AND PHARMACEUTICALS , avoiding these pitfalls is a core part of the company’s quality-driven manufacturing philosophy. This blog explores the most common mistakes in API manufacturing , their root causes, and best-practice solutions. 1. Treating Quality as a Final Check Instead of a Process ❌ The Mistake Relying heavily on end-product testing instead of building quality into the manufacturing process. ⚠️ Why It’s R...

  API Manufacturing CAPA Systems Strengthening Quality, Compliance & Continuous Improvement By Swapnroop Drugs and Pharmaceuticals Introduction In pharmaceutical manufacturing, quality is not achieved by inspection alone—it is built into the system . One of the most critical pillars of this system is an effective Corrective and Preventive Action (CAPA) framework . In Active Pharmaceutical Ingredient (API) manufacturing , where complex chemical processes and strict regulatory requirements intersect, CAPA systems play a vital role in ensuring consistent quality, regulatory compliance, and continuous improvement . At Swapnroop Drugs and Pharmaceuticals , CAPA systems are designed to not only address problems but to eliminate root causes and prevent recurrence , aligning with ICH Q7, ICH Q9, ICH Q10, USFDA, WHO-GMP, and EU GMP expectations . What Is a CAPA System in API Manufacturing? A CAPA system is a structured quality process used to: Identify qua...