Good Manufacturing Practice and Drug/Food Analysis

1. Overview

   The Faculty of Postgraduate Studies and Scientific Research and the faculty of Pharmacy and Biotechnology at the German University in Cairo (GUC) offer a postgraduate diploma in Quality Control, Quality Assurance, and Testing by Modern Methods in Pharmaceutical Analysis “QCAT diploma”. This 7 months postgraduate diploma provides learners with a broad foundation in good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry covering finished human, biologics and nutraceuticals, as well as, modern methods of practical pharmaceutical analysis using state of the art instruments and modern techniques of analysis allowing them to have an edge over other pharmacists working in the pharmaceutical industry, academia, research centers, regulatory, consultation governmental and non-governmental agencies.

   The diploma objectives are:

   1. Offer young professionals having a bachelor in pharmacy education (and other health-care related degrees) an opportunity to expand their professional horizons and accelerate their career growth and excellence in the pharmaceutical industry and research, ultimately to boost Egyptian pharmaceutical industrial and research organizations.
   2. Offer working professionals the opportunity to refresh, deepen and build on a comprehensive knowledge and outstanding skills in pharmaceutical analysis, and become Pharmaceutical GMP Professional committed to quality and having a positive impact on employer organizations.
2. Employability and Instructors
   1. Employability

      Academics in pharmacy education, professionals in pharmaceutical industry, national and international regulatory and auditing agencies, researchers and doctorate students in pharmaceutical sector, and entrepreneurs in pharmaceutical sector are eager to have post-graduate courses in Good manufacturing and analysis practices to build, refresh or upgrade their knowledge in the field with international guidelines and cutting edge techniques.

      The Diploma graduate can be employed in widely varied fields including:

      1. Entry, middle and upper level pharmaceutical analysis-related positions in the industry (Quality Control department, Quality Assurance and production departments in the pharmaceutical, chemical and food industry).
      2. Entry middle and upper level positions in research oriented organizations (Research and Development departments in the pharmaceutical industry, research centers, institutes and universities).
      3. Entry, middle and upper level positions in pharmaceutical academia.
   2. Instructors:

      Courses are delivered by experts from both pharmaceutical and biopharmaceutical industry and research, using state-of-the-art technologies, to provide the learners with strong technical and practical skills needed as per the International Conference on Harmonization (ICH) regulated work environment.

3. Objectives and Outcomes
   1. Diploma’s Objectives:

      At the completion of the Diploma, the diploma holder will be able to:

      1. Apply knowledge and understanding, and problem solving abilities, in constantly arising regulatory and analytical challenges and multidisciplinary applications using quality control, quality assurance and pharmaceutical analysis tools to deduce conclusions related to different industrial and research disciplines.
      2. Comprehend sterile and nonsterile manufacturing systems and be able to analyze master and completed batch records, material control procedures, and contamination controls.
      3. Comprehend product design factors and phase appropriate GMP requirements.
      4. Master fundamental understanding of regulatory agency governance, including global regulatory framework, relevant regulations and guidelines, and mutual recognition agreements.
      5. Determine requirements and specifications for construction of facilities, utilities and equipment, evaluate automated or computerized systems, and apply business continuity plans and disaster recovery techniques.
      6. Use sampling plans and apply procedures for shipping and receiving materials, analyze in-house storage, identification, and rotation of materials, and meet requirements for materials traceability and sourcing, including returned goods.
      7. Integrate knowledge to perform a full analytical method development, troubleshoot analytical and instrumental problems.
      8. Develop self- directed or autonomous learning skills, and to take responsibility of academic and professional development
      9. Develop and apply elements and requirements of a quality system, evaluate various types of audits and self-inspections, and analyze documents and record management systems.
      10. Distinguish between and verify suitability of factors relating to laboratory systems, including relevant compendia for the United States, Europe, and Japan, investigations of aberrant laboratory results, and instrument control and record-keeping.
      11. Develop and evaluate filling and packaging operations and controls, and analyze technology transfer activities.
   2. Diploma’s Outcomes:

      After completing the Diploma, the learner should be able to

      1. Knowledge and understanding::

         A1. Comprehend the basic concepts and theories of analytical chemistry and instrumental analysis.

         A2. Familiarize with advanced qualitative and quantitative tools and applications of Pharmaceutical analysis with different goals.

      2. .

      3. Professional and practical skills:

         B1. Work independently, self-directed and autonomously.

         B2. Design and implement teamwork processes, work effectively within groups.

         B3. comply with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry of finished human and veterinary drugs and biologics, and dietary supplements, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients) and packaging and labeling operations.

      4. Intellectual skills:

         C1. Diagnose a variety of problems related to different analytical and regulatory situations.

         C2. Analyze, synthesize and act to troubleshoot different theoretical, practical and quality related problems.

         C3. Think critically and creatively.

      5. Transferable skills:

         D1. Continue individually to further develop their knowledge and skills and to integrate new knowledge with previous learning and experiences.

         D2. Communicate in a compelling manner to a range of different audiences.

4. Offered Courses per semester:

   The diploma courses are offered for 8 contact hours from 9 to 5 pm every Saturday. Courses are offered consecutively in order (not parallel). One exam is offered at the end of each semester assessing the learning outcomes of all semester courses. A certificate of completion of each module is submitted at end of each semester while the certificate of the diploma is presented to the learners at the end of the 2 semesters only if they pass the 2 final exams at end of each semester. Attendance of 75% of the sessions is mandatory for issuing any certificate.

   First Semester Courses: Module of “Quality Control and Quality Assurance” (14 weeks):

   Code	No.	Course	Number of Lectures	ECTS
   QCAT	1101	Regulatory Agency Governance	9	3
   QCAT	1102	Quality Management System	15	5
   QCAT	1103	Laboratory Systems and Infrastructure	12	5
   QCAT	1104	Supply Chain Management and Technology Transfer	7	3
   QCAT	1105	Sterile And Non Sterile Manufacturing and Packaging Systems	10	4
   Total ECTS = 20 Credit Points

   Second Semester Courses: Module of “Testing by Modern Methods of Pharmaceutical Analysis” (14 weeks):

   Code	No.	Course	Number of lectures/ practical sessions	ECTS
   QCAT	1301	Basic Concepts of Pharmaceutical Analysis	12	4
   QCAT	1302	Systematic HPLC Method Development And Validation	12	4
   QCATp	1303	Practical Pharmaceutical Analysis I (Practical Course)	12	5
   QCATR	1304	Project (Part I)	1	2
   QCAT	1401	Advanced Concepts of Pharmaceutical Analysis	12	4
   QCAT	1402	Pharmaceutical And Biological Analytical Applications	12	4
   QCATp	1403	Practical Pharmaceutical Analysis II (Practical Course)	12	5
   QCATR	1404	Project (Part II)	1	2
   Total ECTS = 30 Credit Points

Admission Requirements

According to German University in Cairo admission to this program is competitive. The admission criteria are:

1. Bachelor degree from a recognized University.
2. An acceptable score on the GUC English admission test.

Admission Steps:

The German University in Cairo admits the diploma’s students two times a year; winter (admission in May– the semester starts in October) and spring semester (admission in November – the semester starts in February) The admission procedures are as follows:

1. Applicants complete online application Apply Now !
2. Applicants that fulfill the requirements will be invited via e-mail to take the GUC English admission test (GUC graduates are exempted from this test).
3. Applicants who are accepted will be invited to attend an orientation session. Applicants not accepted may reapply in future semesters.

Documents Needed:

The applicant must bring all documents mentioned below:

1. Curriculum vitae
2. University transcript (with grades of each subject)
3. Graduation certificate
4. Two passport-sized photos
5. Birth certificate
6. Military status for male applicants
7. Copy (front & back) of the National ID Card/ or passport for non Egyptian students
8. Visa and residency documents for non-Egyptians

Tuition & Fees:

*Insurance fees are refundable in case no damage are done or books are lost

**semester fees Paid in two installments during each semester