Post on 08-Apr-2018
transcript
8/7/2019 Intro to PHM2292_ Indusrial Pharmacy & Regulation_Maryanto
http://slidepdf.com/reader/full/intro-to-phm2292-indusrial-pharmacy-regulationmaryanto 1/10
PHM 2292: INDUSTRIALPHARMACY & REGULATION
Course Synopsis, Objective and learning OutcomeTopics
AssignmentsStudent Learning Time (SLT)
Prepared and Presented by DR. Maryanto
KULLIYYAH OF PHARMACYCourse No. Subject
Year/Semester
RevisionDate
Presented
INTERNATIONAL ISLAMIC UNIVERSITY MALAYSIA PHM- 2292 Briefing 2/2 1 December 2010
8/7/2019 Intro to PHM2292_ Indusrial Pharmacy & Regulation_Maryanto
http://slidepdf.com/reader/full/intro-to-phm2292-indusrial-pharmacy-regulationmaryanto 2/10
This course will expose the student to several aspects ofdrug production, e.g. product development /design,production processes, machinery/equipment, appropriatequality control and quality system.
Several importants topics related to industrial pharmacy,such as clinical trials, quality control, PAT and drug stabilitymonitoring will be introduced.
Legal and regulatory aspects will be discussed to ensure thestudent to understand on the regulatory requirements toproduce quality and effective drugs (cGMP).
8/7/2019 Intro to PHM2292_ Indusrial Pharmacy & Regulation_Maryanto
http://slidepdf.com/reader/full/intro-to-phm2292-indusrial-pharmacy-regulationmaryanto 3/10
8/7/2019 Intro to PHM2292_ Indusrial Pharmacy & Regulation_Maryanto
http://slidepdf.com/reader/full/intro-to-phm2292-indusrial-pharmacy-regulationmaryanto 4/10
Describe the requirements for drug production, productionprocesses and related machinary/equipment.
Display understanding in quality control and qualitymanagement system required in a drug manufacturingcompany.
Explain legal and regulatory aspects in ensuring the
production of quality and effective drugs.
Explain other aspects of industrial pharmacy including basicstatistics on clinical trials and drug stability study.
8/7/2019 Intro to PHM2292_ Indusrial Pharmacy & Regulation_Maryanto
http://slidepdf.com/reader/full/intro-to-phm2292-indusrial-pharmacy-regulationmaryanto 5/10
ManufacturingProcesses
Design andDosage Forms
Processing ofPowders
Sterilisation
Processing ofLiquids
Drug Stability Clinical Trials Clean Room
Quality Control/ Assurance
GoodManufacturing
PracticePAT
PharmaceuticalRegulations
8/7/2019 Intro to PHM2292_ Indusrial Pharmacy & Regulation_Maryanto
http://slidepdf.com/reader/full/intro-to-phm2292-indusrial-pharmacy-regulationmaryanto 6/10
8/7/2019 Intro to PHM2292_ Indusrial Pharmacy & Regulation_Maryanto
http://slidepdf.com/reader/full/intro-to-phm2292-indusrial-pharmacy-regulationmaryanto 7/10
Factory visit – KOP Pilot Plant
Any aspect of drug production: process, production premissesand 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
8/7/2019 Intro to PHM2292_ Indusrial Pharmacy & Regulation_Maryanto
http://slidepdf.com/reader/full/intro-to-phm2292-indusrial-pharmacy-regulationmaryanto 8/10
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 ASSIGNMENTNO 2 ASSIGNMENTS THAT ARE SIMILAR
Assignment must be submitted by the week 13
8/7/2019 Intro to PHM2292_ Indusrial Pharmacy & Regulation_Maryanto
http://slidepdf.com/reader/full/intro-to-phm2292-indusrial-pharmacy-regulationmaryanto 9/10
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