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FTE-2160 GOOD MANUFACTURE PRACTICES AND VALIDATION

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					Course Title-Course Code: GOOD MANUFACTURE                   Name of the Programme: Pharmaceutical
PRACTICES AND VALIDATION - FTE -2160                         Technology Department
                                           Teaching Methods                                       Credits
     Semester                                                                                       ECTS
                 Lecture    Recite     Lab.                             Other     Total      Credit
                                                                                                    Credit
        II         28                                                               28         2          4,5
Language         Turkish
Compulsory /
Elective
                 Elective
Prerequisites    Non existing
Course           GMP, GLP, GPP, GSP, GDP, Quality assurance, safety, efficacy, production area,
Contents         documentation, validation (process, analytical methods), validation parameters (Spesifity,
                 presicion, accuracy, sensitivity, linearity, rudgedness, robustness, stability), quality control,
                 quality assurance, storage, patent.
Course           Teaching: Understanding of the fundamentals and basic practical concepts of GMP and
Objectives       validation such as quality assurance, safety, efficacy, production area, documentation,
                 validation (process, analytical methods), validation parameters
Learning         Learning: Understanding of the fundamentals and basic practical concepts of GMP and
Outcomes and     validation such as quality assurance, safety, efficacy, production area, documentation,
Competences      validation (process, analytical methods), validation parameters
Textbook and     Good manufacturing Practices for Pharmaceuticals. S.H.Willing, Marcel Dekker, New
/or References   York, 2001
                 Pharmaceutical Process Validation, R.A.Nash, A.H.Wachter, Marcel Dekker, New York,
                 2003
                                                                                             If any        Percent
Assessment                                                                                 mark( x)         (%)
Criteria
                 Midterm Exams
                 Quizzes
                 Homeworks                                                                     x            10
                 Projects                                                                      x            30
                 Term Paper
                 Laboratory Work
                 Other
                 Final Exam                                                                    x            60
Instructors      Prof.Füsun Acartürk, Assoc.Prof.Sevgi Takka
Week
                 Subject
1                Introduction to GMP, the descriptions and applications in the world
2                Facilities, equipment and personnel according to GMP
3                Documentation (specification, record books, reports, SOPs),
4                Manufacturing according to GMP
5                Packaing and labelling, the applications of good storage/good distrubution
6                Complaints and recall process; salvaging, inspection/self inspection
7                Introduction to GLP and the descriptions
8                Drug quality control/ the design of quality conreol laboratories
9                The description of validation, the purpose and contents, preparation of validation protocal
                 and reports
10               Process validation and the classification (prospective and retrospective validation)
11               Process validation and the classification (prospective and retrospective validation)
12               Process validation and the classification (revalidation and concurrent validation)
13               Analytical metod validation
14               Analytical metod validation

				
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posted:11/2/2011
language:English
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