Quality Assurance

{ DOWNLOAD AS PDF }

ABOUT AUTHORS
Suleman S. khoja ¹, Sohil S khoja ¹,Parthkumar H chauhan ²,Farhad S Khoja
¹Resource person in pharmaceutical quality assurance ,VAPI, Gujarat.
²Resource person in quality assurance ,NAVSARI, Gujarat.
³Registered Pharmacist ,VAPI, Gujarat.
premukhoja@gmail.com

ABSTRACT
A review on USFDA observation and finding while inspection of Pharmaceutical the present review provide some important , Significant observation and measure of compliance.USFDA is an regulatory body governing health products which are made ( in or  outside USA) and marketed in united States of America. Significant deviation from cGMP and Significant violation from cGMP for both API Facility and formulations .strictly compliance requirements under 21 Code of federal regulations (CFR). FDA observation includes but not limited to this. If not cleaned and maintained equipment at appropriate intervals to prevent contamination that would alter the Safety, Identity, Strength, Purity and Quality of drug product (SISPQ) ,violation under [ 21 CFR & 211.67 (a) ]. Data integrity is main issue Raised in most FDA warning letter. Corrective action and plan. Level of control must be raised from raw material, packaging material (Accurate, Legible, Contamptarious, Original, Attributable (ALCOA)) in process, finished dosage form, Maintain log book properly. Guidelines for Out of specification(OOS ) and out of trends(OOT)  must be follow if any required.

The University Institute of Pharmaceutical Sciences of the Panjab University is a premier institution of Pharmaceutical Education and Research in the country. The institute has covered a long and glorious journey of 76 years starting from Lahore in 1944 and finally settling to the present campus in Chandigarh at the foothills of Himachal. In its travelogue, the institute crossed multiple milestones and continue to head ahead towards the well-defined goals. The elevation of the status from department to the level of an institute i.e. University Institute of Pharmaceutical Sciences in 1994, and hosting of Indian Pharmaceutical Congress in the same year, two presidential honors of the Indian Pharmaceutical Congresses to its faculty members, a special recognition by the UGC by granting SAP in 1993 and COSIST in 1981 establishment of ICMR Advanced Centre for standardization of Drugs of Indian System of Medicine are some of the major hallmarks on the path treaded so far.

Hospira is the world's leading provider of injectable drugs and infusion technologies. Through our broad, integrated portfolio, we are uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs.
Through our offering of high-quality, lower-cost generic medications, we continue to help reduce the overall costs of healthcare — to improve both the affordability of care for patients and the financial strength of the global healthcare system.

Post: Senior Manager-MS&T Compliances

Hospira is the world's leading provider of injectable drugs and infusion technologies. Through our broad, integrated portfolio, we are uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs.
Through our offering of high-quality, lower-cost generic medications, we continue to help reduce the overall costs of healthcare — to improve both the affordability of care for patients and the financial strength of the global healthcare system.

Post: Manager-Training Remediation

The University of North Bengal was established by Act of the Legislature of West Bengal in 1962 and assigned the mandate of providing teaching, training and research in various branches of advanced learning, and promoting the dissemination of knowledge to fulfill growing socio-economic and technical manpower needs in the six North Bengal districts and the neighbouring state of Sikkim. The campus occupies an area of about 330 acres 9 km outside Siliguri and Bagdogra Airport in the Terai region of Darjeeling district.

Doon Valley Group of Institute, Karnal, Haryana founded in the year 2004, has established its own identity in the field of PHARMACY, Education, Management, Engineering and Food Technology for Undergraduate courses, CBSE School and PG courses offered by the Institute in the field of Pharmacy and Management.

We require URGENTLY the following positions at Doon Valley Institute of Pharmacy and Medicine, Karnal, Haryana-

Post: Professor, Associate Professor, Assistant Professor

The vision of NMIMS University is to define the 21st century technological and management research. Hence the goal for NMIMS University is to encourage excellence in research and publication activities. Research is a precursor to discovery and innovation.