B Pharmacy
ISO 9000 Series
ISO 9000 The ISO 9000 family of standards is designed to help organizations to ensure the customers’ needs, …
Out of Specification (OOS)
When an analytical or test result of any batch or material is out of prescribed and predetermined limits …
Six Sigma Concepts
Six Sigma Concepts Introduction: Six sigma concepts are a principle for process improvement. Six Sigma represents the quality …
Quality By Design (QbD)
Quality By Design Introduction: Pharmaceutical industries always rely on continuous improvement in the safety, quality, and efficacy of …
Total Quality Management
Total Quality Management Introduction: The pharmaceutical industry is a key part of the health care system. The regulation …
Clinical Research Protocols
Introduction: Clinical Research Protocols is a complete written description of and scientific rationale for a research activity involving …
New Drug Application (NDA)
The vehicle through which drug sponsors formally propose that the regulatory body approves a new pharmaceutical for sale …
Investigational New Drug Application
Introduction: Investigational New Drug (IND) is a program by which any pharmaceutical company can approach to obtain permission …
Regulatory Requirements for Drug Approval
For Drug Approval Currently, different nations have to follow different requirements for the regulatory approval of novice drugs. …