About Me



Welcome,

Myself Biren Ghodasara, I have more than 10 years experience in pharmaceutical industry in different area like Pharmaceutical industry Quality control Quality assurance, local pharmacy, Marketing chain.

Objective of creating the blog to the guide Quality control against compliance and productivity.

This blog open discussion forum for the different topic to the pharmaceutical industry directly and indirectly related to the Quality Control.

Popular posts from this blog

Analytical worksheet

The analytical worksheet is an internal document to be used by the analyst for recording information about the sample, the test procedure, calculations and the results of testing. It is to be complemented by the raw data obtained in the analysis. Purpose The analytical worksheet contains documentary evidence either: To confirm that the sample being examined is in accordance with the requirements. To support an OOS result. Use A separate analytical worksheet should usually be used for each numbered sample or group of samples. Analytical worksheets from different units relating to the same sample should be assembled together. Content The analytical worksheet should provide the following information: The registration number of the sample. Page numbering, including the total number of pages (and including annexes) The date of the test request. The date on which the analysis was started and completed The name and signature of the analyst A description of the sample...
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Responsibility of management against QMS

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Management Resposibility Senior management is responsible for assigning a management representative to develop and maintain the QMS, acting as representative in all issues concerning quality. Conflicts of interest should be avoided, and the management representative shall be given sufficient authority. The necessary resources shall be available to the management representative, and the responsibilities placed on any one individual shall not be so extensive as to present any risk to product quality. Senior management should ensure: The QMS takes into account all applicable guidelines and regulations Management reviews are performed on a regular basis The quality manual, quality policies, and quality objectives are all in place Job descriptions, responsibilities, and authorities are clearly understood within the organization All necessary resources are provided Communication flows are timely within the organization and the supply chain Quality Management Syste...
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