Journal of Developing Drugs
Open Access

Overview of data integrity in the pharmaceutical laboratory and current regulatory challenges

4^th International Summit on GMP, GCP & Quality Control

October 26-28, 2015 Hyderabad, India

Abhay Gupta

Novartis Healthcare Limited, India

Posters-Accepted Abstracts: J Develop Drugs

Abstract :

In modern scenario GxP data integrity is critical to GMP requirement, patient safety, regulatory compliance, post approval submission and business success. Current daysâ�?�? regulatory authorities have highlighted concern in regions where the industries are rapidly growing especially in some Asian company. Data is all forms of raw, processed and recorded data, and associated records and documentation i.e., paper, digital/electronic, photographic/video and audio. Data integrity is transparent generation, acquisition, processing, evaluation, recording, reporting, protection and security of complete and accurate data, records and documentation. Data is generated in accordance with applicable GxP requirements that assure the reliability of data, records and documentation. Some of the macro root causes which erode data integrity are financial motivation, business pressure, organizational culture and working environment. Data integrity problem related to all GMP environments which mainly include quality assurance, quality control testing lab, product stability testing lab, validations, development labs, manufacturing packing and maintenance, engineering, etc. FDA has targeted India as a region that warrants close inspection and enforcement actions based on the following risk factors: â�?¢ Indiaâ�?�?s pharmaceutical industry is relatively young and rapidly growing â�?¢ A major amount of API and FP generic drugs are sourced from India â�?¢ High rate of unacceptable inspection results To control data integrity, it is necessary to develop a corporate ethics program that includes clear policy statement and expectation for employee conduct improvement. â�?�?Healthâ�?�? of operating environment include â�?¢ Periodic trainings â�?¢ Disciplinary action against unethical practices â�?¢ Risk assessment for identifying gaps â�?¢ Company management should be committed to provide necessary training, resources, support and work culture.

Biography :

Email: abhay.gupta@novartis.com