by Dr. Yashashwini Reddy | Aug 12, 2025
Change Control in Pharmaceuticals Definition:Change control is a formal GMP-compliant system used to manage and document any change in processes, equipment, materials, methods, documents, or facilities to ensure that product quality, safety, and regulatory...
by Dr. Yashashwini Reddy | Aug 9, 2025
Non-conformance in Pharmaceuticals Definition:Non-conformance refers to any deviation from established standards, specifications, regulatory requirements, or approved procedures in the pharmaceutical manufacturing, testing, or distribution process. Examples of...
by Dr. Yashashwini Reddy | Aug 9, 2025
The Shape of Pharmaceutical Dosage Forms Definition:In pharmaceuticals, dosage form shape refers to the physical appearance and geometry of the medicine, which can influence patient compliance, swallowing ease, identification, and manufacturing efficiency. 1. Solid...
by Dr. Yashashwini Reddy | Aug 8, 2025
Resolving API Impurity Issues in Drug Development 1. Understanding the Issue In drug development, impurities in the Active Pharmaceutical Ingredient (API) can arise from: Starting materials or intermediates (process-related impurities) By-products from synthesis steps...
by Dr. Yashashwini Reddy | Jun 9, 2025
Purpose of Process Validation in Pharmaceuticals Process validation is a critical activity in pharmaceutical manufacturing that ensures a process consistently produces a product meeting its predetermined quality attributes. The purpose of process validation is to...
