Gujarat

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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

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 Officer / Executive Injection & Tablet

Cliantha Research, a leading life science company, is a global full service Contract Research Organization with integrated offerings in Clinical, Bioanalytical, Dermatology, Biometrics, Pathology and Formulation services.

Alembic Pharmaceuticals Limited, with an established presence in the Indian pharma industry has a proud, historical track record going back over 100 years.  To realize our ambitious plans, we call upon dynamic, result oriented team members to join our API & Formulation manufacturing unit located at PANELAV, near Vadodara (Gujarat).

Post : Sr. Executive /Executive - Quality Control (Formulations)

Shree Dhanvantary Pharmaceutical Analysis and Research Centre (SDPARC) is a contract research organization established in 2006 and is managed by RIBOSOME PHARMA PVT. LTD., Surat. SDPARC offers a wide range of analytical & research services for small, medium and large scale pharmaceutical, ayurvedic, bulk drug, chemical, food and cosmetic industries.

Aculife Healthcare Private Limited is one of world’s largest manufacturer of Parenterals, Medical Devices and pharmaceutical formulation under one roof. Our products are exported in 70 plus countries and we have more than 4000 dedicated Employee base. Aculife is focused on streamlining its initiatives in the healthcare industry, to keep up with the increasing scale of operations and requirements of the regulated and semi regulated markets across various therapeutic segments.