intro to phm2292_ indusrial pharmacy & regulation_maryanto

8/7/2019 Intro to PHM2292_ Indusrial Pharmacy & Regulation_Maryanto

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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



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).



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.



ManufacturingProcesses

Design andDosage Forms

Processing ofPowders

Sterilisation

Processing ofLiquids

Drug Stability Clinical Trials Clean Room

Quality Control/ Assurance

GoodManufacturing

PracticePAT

PharmaceuticalRegulations



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



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



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

intro to phm2292_ indusrial pharmacy & regulation_maryanto

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