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    Intro To PHM2292 - Indusrial Pharmacy & Regulation - Maryanto

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    sayed_fahmi_1
    This document provides an overview of the PHM 2292 course on Industrial Pharmacy and Regulation. The course will cover various aspects of drug production including product development, manufacturing processes, quality control, and legal/regulatory requirements. Topics include clinical trials, quality assurance, process analytical technology, and drug stability monitoring. Assessments include assignments, quizzes, laboratory practicals, and essays. The course aims to provide understanding of drug manufacturing processes and equipment as well as quality and regulatory requirements.

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    Intro To PHM2292 - Indusrial Pharmacy & Regulation - Maryanto

    Uploaded by

    sayed_fahmi_1
    72 views10 pages
    This document provides an overview of the PHM 2292 course on Industrial Pharmacy and Regulation. The course will cover various aspects of drug production including product development, manufacturing processes, quality control, and legal/regulatory requirements. Topics include clinical trials, quality assurance, process analytical technology, and drug stability monitoring. Assessments include assignments, quizzes, laboratory practicals, and essays. The course aims to provide understanding of drug manufacturing processes and equipment as well as quality and regulatory requirements.

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    Intro to PHM2292_ Indusrial Pharmacy & Regulation_Maryanto

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    This document provides an overview of the PHM 2292 course on Industrial Pharmacy and Regulation. The course will cover various aspects of drug production including product development, manufacturing processes, quality control, and legal/regulatory requirements. Topics include clinical trials, quality assurance, process analytical technology, and drug stability monitoring. Assessments include assignments, quizzes, laboratory practicals, and essays. The course aims to provide understanding of drug manufacturing processes and equipment as well as quality and regulatory requirements.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    72 views10 pages

    Intro To PHM2292 - Indusrial Pharmacy & Regulation - Maryanto

    Uploaded by

    sayed_fahmi_1
    This document provides an overview of the PHM 2292 course on Industrial Pharmacy and Regulation. The course will cover various aspects of drug production including product development, manufacturing processes, quality control, and legal/regulatory requirements. Topics include clinical trials, quality assurance, process analytical technology, and drug stability monitoring. Assessments include assignments, quizzes, laboratory practicals, and essays. The course aims to provide understanding of drug manufacturing processes and equipment as well as quality and regulatory requirements.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 10

    PHM 2292: INDUSTRIAL

    PHARMACY & REGULATION


    Course Synopsis, Objective and learning Outcome
    Topics
    Assignments
    Student Learning Time (SLT)

    Prepared and Presented by DR. Maryanto

    Year/ Date
    Course No. Subject Revision
    KULLIYYAH OF PHARMACY Semester Presented

    INTERNATIONAL ISLAMIC UNIVERSITY MALAYSIA


    PHM- 2292 Briefing 2/2 1 December 2010
    This course will expose the student to several aspects of
    drug production, e.g. product development /design,
    production processes, machinery/equipment, appropriate
    quality control and quality system.

    Several importants topics related to industrial pharmacy,


    such as clinical trials, quality control, PAT and drug stability
    monitoring will be introduced.

    Legal and regulatory aspects will be discussed to ensure the


    student to understand on the regulatory requirements to
    produce quality and effective drugs (cGMP).
    This course is designed to provide understanding on
    several aspects of drug manufacturing: processes,
    machinary/equipment & premises and applicable
    regulations.

    The course will provide students with the knowledge


    and basic understanding on the requirement for
    different kinds of processes and techniques employed
    in drug manufacturing of several drug dosage forms
    (drug deliveries) and means for assessing the quality
    and properties of drug manufactured.
    Describe the requirements for drug production, production
    processes and related machinary/equipment.

    Display understanding in quality control and quality


    management system required in a drug manufacturing
    company.

    Explain legal and regulatory aspects in ensuring the


    production of quality and effective drugs.

    Explain other aspects of industrial pharmacy including basic


    statistics on clinical trials and drug stability study.
    Manufacturing Design and Processing of
    Sterilisation
    Processes Dosage Forms Powders

    Processing of
    Drug Stability Clinical Trials Clean Room
    Liquids

    Good
    Quality Control/ Pharmaceutical
    Manufacturing PAT
    Assurance Regulations
    Practice
    METHODS %
    Continuous assessment 50
    Assignments (2) 20
    Quizzes 20
    Laboratory Practical (2) 10

    End- semester exam 50


    Short essay (4 out of 5) 20
    Long essay (3 out of 4, 2 hours) 30
    Total 100
    Factory visit – KOP Pilot Plant

    Any aspect of drug production: process, production premisses


    and facilities (machinary or equipment).
    • General
    • Introduction
    • Company
    • Organization structure (authority and responsibility)
    • Specific, e.g.
    • Production (e.g. tableting, capsule, cream)
    • Quality control
    • Production quality system
    • Miscellaneous

    Assignment must be submitted by the week 9


    Free topic relating to
    Quality systems & Regulatory in pharmaceutical Industry
    • cGMP
    • cGLP
    • Applicable quality system in clinical trials
    • New product registration
    • Product stability study
    • PAT

    INDIVIDUAL ASSIGNMENT
    NO 2 ASSIGNMENTS THAT ARE SIMILAR

    Assignment must be submitted by the week 13


    STRATEGY CLASS PRE/POST TOTAL
    Lectures 26 26 52
    Laboratory practical 6 6 12
    Tutorial - - -
    Assignment (2) 12
    Industrial visit 8 10 18
    Exam (End) 2 12 14
    TOTAL 92/40 + 18/80 = 2.5

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