Takhtaulova N. The organization of validation activity at the pharmaceutical enterprise

Українська версія

Thesis for the degree of Candidate of Sciences (CSc)

State registration number

0413U000413

Thesis Registration Form

0413U000413.pdf

Applicant for

Specialization

  • 15.00.03 - Стандартизація та організація виробництва лікарських засобів

21-01-2013

Specialized Academic Board

Д 64.605.01

National University of Pharmacy

Essay

The thesis is devoted to the development and scientific basis of proposals for the organization of validation activities at the enterprise of medicines production. The organizational structure of validation works integrated in the quality management system is compiled based on these studies; the competence requirements for qualification and validation personnel are determined, approaches to study and attestation of this personnel are proposed, recommendations for documenting validation activities are developed.

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Files

Avtoreferat_-_Takhtaulova_-_11-12-2012.doc

Disser Takhtaulova 11-01-2013.doc

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