Mr.Hitendra Kumar Shah

Data Integrity is currently the major concern with both the FDA and European Regulatory Agencies. Many FDA warning letters and EU GMP inspections have highlighted major data integrity failures at companies globally. The emphasis of all regulators is on the AL ...

All the pharmaceutical organizations are working hard for GMP compliance so as to get good business. The business growth is achieved by following GMP norms so as to increase technical and financial strengths of pharmaceutical organizations. As, pharmaceutical ...

Auditing is defined as the on-site or off site verification activity, such as inspection or examination, of a process and six systems including quality systems, to ensure compliance to requirements.  An audit can apply to an entire organization or might be sp ...

CAPA stands for Corrective and Preventive Action. It's a systematic process used in industries like manufacturing, healthcare, and pharmaceuticals to identify, address, and prevent problems or non-conformities. CAPA is a crucial part of a quality management s ...

The most crucial factor to achieve Business Growth in Pharma manufacturing nowadays, is Compliance with GMP norms, so as to increase the technical and financial strength of Manufacturing units. Currently, the aspect focused on by most Auditors, both internal, ...