Navasari

GPSSB, ahmedabad invites online applications for direct recruitment of compunder or pharmacists (class-3). Candidates can apply from 17-11-2016 to 30-11-2016 (till night 11.59 hour) and exam bees should be deposited in post ofiice till 02-12-2016. Candidate should upload recent photograph and signature in scan format.

Post: Compounder

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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.

Medley was accredited as ISO - 9001 : 2000 company during the year 2003, by American Quality Assessors (AQA). Medley believes that quality is a continuous process and not an isolated stage in the process.
Medley's strength has also been it's product portfolio which has expanded in response to the market needs. As a strategic move towards success, the company has launched its cadiovascular, anti diabetic and neuropsychiatry products through its highly specialized VAZOKARE division.