natural-products-congress-world-pharma-congress-2017-tracks

24 / 25

Page 49
Notes:
Volume 4, Issue 2 American Journal of Ethnomedicine
ISSN 2348-9502
Natural Products Congress & World Pharma Congress 2017
October 16-18, 2017
3rd World Congress on
NATURAL PRODUCTS CHEMISTRY AND RESEARCH
&
12th WORLD PHARMA CONGRESS
October 16-18, 2017 Budapest, Hungary
Importance of data integrity in pharmaceuticals
Raghunandan H V
JSS University, India
As per USFDA, data integrity refers to the completeness, consistency and accuracy of data. Complete, consistent, and accurate
data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).World Health
Organization (WHO) defines data integrity as the degree to which a collection of data is complete, consistent and accurate throughout
the data lifecycle. The collected data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate.
Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles
and good documentation practices. USFDA expects data to be reliable and accurate, necessary to have flexible and risk-based
strategies to prevent and detect data integrity issues, implement meaningful and effective strategies to manage their data integrity
risks. The expectation of MHRA with respect to data integrity is the governance system should be integral to the pharmaceutical
quality system. Data integrity is related to many stakeholders like patients, regulators and organization. Data integrity is applied at all
stages of product life cycle from discovery to distribution and applied on GXP systems, facilities, quality system, data functions and
regulatory submissions. Data integrity does matter because it is necessary to establish confidence that the quality related activities are
being performed effectively and regulatory decisions depends on accurate data across product lifecycle. Data integrity lapses lead to
prosecution, injunction, penalty, warning letters and import alerts affecting the overall business of the organization.
Biography
Raghunandan H V is currently working as Professor of Pharmaceutics JSSCP and worked as Pharmacist with over 23+ years of progressive experience in
pharmaceutical quality assurance, quality control, regulatory affairs, manufacturing of formulations/API’s/biologicals, contract manufacturing and pharmaceutical
technical consultation (reg. affairs, product development and quality). He has good understanding of the audits and risk management in pharmaceuticals/bio
pharmaceuticals, consumer health care products like OTC/OHC/nutritional health care. He is an experienced Quality Auditor and has good experience in auditing
and site quality management.
Raghunandan H V, American Journal of Ethnomedicine, 4:2
DOI: 10.21767/2348-9502-C1-002