Monday, June 17, 2013

What is training ? What are the functions of Qualified and key personnel in a Pharmaceutical Industry ?



1.What is training ? Why it is needed ?

Training: Training is a tool/way to know something to increase our knowledge or skill.

Importance of training:

Training helps to provide an opportunity and broad structure for the development of human resources technical and behavioral skills in an organization. It also helps the employees in attaining personal growth.

2.What are the functions of Qualified and key personnel in a Pharmaceutical Industry ?
              I.A qualified person must ensure that each batch has been produced & tested/ checked in accordance with the directives & marketing authorization
           II.A qualified Person musr certify in a register or equivalent document as operations are carried out & before any release that each production batch satisfies under the requirement of GMP

Functions of key personnel in a Pharmaceutical Industry:
              I.To ensure that the production records are evaluated and signed be an authorized person before they are sent to the QC department.
           II.To check the maintenance of his department, premises and equipment.
         III.To ensure that the appropriate validations are done.
        IV.To approve or reject, as sees fit, starting materials, packaging materials. And intermediate, bulk & finished products.
           V.To evaluate batch records.
        VI.To ensure that all necessary testing is carried out
      VII.To approve specifications, sampling instructions, test methods and Quality Control procedures.
   VIII.To approve and monitor any contract analysis.

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