Gujarat

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

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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.

Zydus Cadila is one of Indias leading healthcare companies and a global healthcare provider with strengths all along the pharmaceutical value chain. The groups state-of-the-art manufacturing infrastructure is spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim and the R&D Centers are spread across Ahmedabad, Baroda and Mumbai (Thane).

Post : OFFICER / EXECUTIVE / SENIOR EXECUTIVE / ASSISTANT MANAGER / DEPUTY MANAGER

Shree N. L. Patel College of Pharmacy, Umrakh was established in the year 2004 under the ages of Vidyabharti Trust with main objective of visionary in the mission of quality Pharmacy education.  The Shree N. L. Patel College of Pharmacy is located on the way of Bardoli-Mota road 3 kilometer away from Bardoli and 34 kilometer away from Surat in a lush green sprawling campus with sufficient infrastructure facilities.  The college is approved by the Pharmacy Council of India (PCI), New Delhi, All India Council for Technical Education (AICTE), New Delhi, recognized by Government of Gujarat and affiliated to Gujarat Technological University (GTU), Ahmadabad.

Post : Faculty

Established in 1976, J.B. Chemicals & Pharmaceuticals Ltd. (JBCPL) is one of India fastest growing pharmaceutical companies. An integrated, research-oriented, public listed organisation with a focus on supplying affordable, quality products both in India and International markets, JBCPL is trusted by healthcare professionals globally. Today, JBCPL exports to over 30 countries across the world and earns more than half its revenue from its international business.

Post : Quality Control Officer / Executive