Gujarat

Piramal Enterprises Ltd. provides a world class integrated drug discovery services platform from our state-of-the-art research Centre in India. PDS's delivery model has a proven track record of providing a step change in the effectiveness of drug discovery for a range of global pharmaceuticals and biotechnology companies operating at the forefront of drug discovery. PDS understands that early and intensive evaluation of the molecules based on thorough communications and rapid decision-making will lead to a high throughput of successful drug-like compounds.

Post : Trainee/ Sr. Research Associate/ Research Scientist

Unison Pharmaceuticals Private Limited (Formerly known as Unison Pharmaceuticals) was established in 1981 with a vision of providing quality & most affordable medicines across the nation. With more than 3 decades of medical service to the society, Unison is today one of the fastest growing company in Gujarat State.

ITM University is a multidisciplinary university known for its quality of research and teaching across the academic spectrum, with subjects spanning the sciences, engineering, management, fine arts, social sciences, arts, nursing etc.
It has been at the forefront of learning, teaching and research and leader in many different fields in its educational endeavour. In a relatively short-time span it has created an image for its excellence as an institution of higher learning through outstanding teaching and world-class research so as to produce well-rounded graduates with lifelong abilities to provide leadership within the societies they serve. We have a well-deserved reputation for last 15 years for excellence, as demonstrated by host of educational institutions already operating under out flagship banner i.e., ITM Universe.

Post: Professors, Associate Professors, Assistant Professors

ABOUT SUMANDEEP VIDYAPEETH:
SumandeepVidyapeeth was established on 17th January 2007 and is declared as Deemed to be university u/s 3 of UGC Act, 1956. The University is accredited by National Assessment & Accreditation Council (NAAC) with a CGPA of 3.53 on a four point scale at ‘A’ Grade, in the year 2015. It is a renowned Healthcare University in state of Gujarat that indoctrinates Health-care Education and Training of high merits. SumandeepVidyapeeth incorporates globally benchmarked ‘Evidence Based Education System’ in all its academic programs. With strong research culture, excellent student-centric academic ambience, well equipped Tertiary care super-specialty Hospitals and exquisitely efficient academicians & researchers, the university is constantly marching towards the summit of excellence.

Aculife Healthcare Private Limited is one of world’s largest Infusion & Injectable Company, having its global operation spread across 70 countries including JV Company in Brazil & wholly owned subsidiary in Mexico. 8 Manufacturing Plants Backed up by state of the art. Aculife Research Centre & 4000 plus Employee base in India & abroad. To keep up with the scale of operations & requirements of regulated and semi regulated markets, Aculife is enhancing its focus on healthcare initiatives across the global Markets.

J. B. Chemicals & Pharmaceuticals Ltd. (JBCPL), known to many as Unique Pharmaceutical Laboratories is one of India's leading global pharmaceutical companies. The company manufactures and markets a wide range of pharmaceutical formulations.

Post : Officer / Executive QA (injectable Plant, Panoli Gujarat)

J. B. Chemicals & Pharmaceuticals Ltd. (JBCPL), known to many as Unique Pharmaceutical Laboratories is one of India's leading global pharmaceutical companies. The company manufactures and markets a wide range of pharmaceutical formulations.

Post: QC

[adsense:336x280:8701650588]

{ DOWNLOAD AS PDF }

ABOUT AUHTORS
Suleman S. khoja * 1, Sohil S khoja 1,Parthkumar H chauhan 2,Farhad S Khoja 3 ,Shamim S Khoja3.
1) Resource person in Pharmaceutical Quality Assurance, Audit and Compliance, Vapi -396191.
2) Resource person in Quality Assurance, Navsari
3) Registered Pharmacist ,Gujarat State Pharmacy council, Vapi -396191
*premukhoja@gmail.com

ABSTRACT:
Data integrity is fundamental in a pharmaceutical quality system which ensures 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), Arrangements shall be in place within an organisation with respect to people, systems and facilities that shall be  designed, operated and where appropriate adapted to support a working environment and  organisational culture that ensures data is complete consistent and accurate in all its forms, i.e. paper  and electronic record .When taken collectively these arrangements fulfil the concept of data governance. Regulatory bodies expect that data shall be reliable and accurate. CGMP regulations and guidance allow for flexible and risk-based strategies to detect and prevent data integrity issues. Industry should implement meaningful and effective strategies to manage their data integrity risks based upon their process understanding and knowledge management of technologies and best business models. In recent year Regulatory observation has increasingly observed GMP violations involving data integrity risks during CGMP inspections. This is troublesome because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, Regulatory is concern with ability to protect the public health.