1. NOVUGEN PHARMA (M) SDN. BHD
NURUL ATIRAH BINTI ABDUL RAZAK
SA15055
Bachelor of Applied Science (Hons.) Industrial
Chemistry
Faculty of Industrial Science and Technology
(FIST)
2. COMPANY BACKGROUND
Chief Executive Officer (CEO) : Junaid Waheed
Established since 2016
Full-fledged active pharmaceutical ingredient (API)
development (R&D) centre in Shah Alam, Glenmarie,
Selangor along with Oncogen Pharma (M) Sdn Bhd.
First Malaysian company to have filed API DMF and
ANDA.
Aims to accelerate the launch of pharmaceuticals that
lack robust generic alternatives due to their complexity
3. COMPANY PRODUCT AND SERVICES
Tablets, capsules and powders
Liquids, solutions, suspensions and emulsions
Lyophilized powders for injection
Drugs in capsule/vial
4. QUALITY CONTROL DEPARTMENT
SESHA REDDI BOMMAREDDI
QUALITY CONTROL
MANAGER
MICROBIOLOGIST QC EXECUTIVE TRAINEE
MRS. ASHIKIN
MR.ASYRAFF
MR. SATHYA
MR. HALIM
MS. HANNAH
MS. FARAH
ATIRAH
ATIQ
ASSOCIATE MANAGER – MR. MADHU
5. WHAT IS QUALITY CONTROL?
MANUFACTURING
MONITORINGTHE
QUALITY OF
FINISHED
PRODUCT (FP)
DEFECT-FREE
PHARMACEUTICAL
PRODUCTS
6. WHAT IS QUALITY CONTROL?
Raw Material
Analysis
In-Process
Analysis
Finished Product
Analysis
Packaging
Material Analysis
TABLETS
CAPSULES
POWDERS
• BLISTER PACK
• STRIP PACK
• CONTAINER PACK
• BULK
CONTAINERS
7. WHAT IS QUALITY CONTROL?
Blister Pack Strip Pack Container Pack
Bulk container for
powders form
8. ROUTINE DAILY BASIS
Standard Operating
Procedure (SOP)
CORE (INSTRUMENT) MANAGEMENT
Good Documentation
Practices (GDP)
9. LIST OF SOP FOR INSTRUMENT
Dynamic and Static Pass Box
Glassware Drying Oven [Binder FD720]
Friability Tester [Electrolab EF 2W]
LOD Oven [Binder FD23]
Sieve Shaker brand [Retsch Germany]
Spectrum Two FT MIR [Perkin Elmer]
TOC-LCSH stand alone High Sensitivity [Shimadzu]
UV Vis [1900 Shimadzu]
Vacuum Oven [Binder VD23]
Vortex Mixer [VELP ZX3]
10. LIST OF SOP FOR MANAGEMENT
Management of biological indicator
Microbiological Best Laboratory Practices
Handling Out of Specification (OOS)
Sampling of packaging materials
Sampling of Raw Materials
Management Of Reference And Working Standards
Good Laboratory Practices
Monitoring of Temperature and Relative Humidity in Quality Control
Laboratory and Microbiology Laboratory
11. PROGRAM – TRAINING
Time Training Session
4th week Good Documentation Practices for SOP
9th week Purchase of Item:
- Operational Expenditure
- Capital Expenditure
12th week On-Site SafetyTraining:
-Personal Protective Equipment (PPE)
- Lockout/Tagout (LOTO) Practices
- Heinrich’s Accident Pyramid
16th week Control of Elemental Impurities
13. ANALYTICAL INSTRUMENT QUALIFICATION
(AIQ) PROCESS
DESIGN QUALIFICATION (DQ)
Functional and operational specification with intended purpose of the
instrument.
Procedures to prepare DQ documentation:
Clarify the objectives for using the equipment
Clarify functional and performance requirements – create URS
Clarify the supplier selection criteria
14. ANALYTICAL INSTRUMENT
QUALIFICATION (AIQ) PROCESS
INSTALLATION QUALIFICATION (IQ)
Compile, confirm and record equipment-related information for a particular
instrument:
To check whether items for installed system fulfill the requirement
specification for the purpose of purchase.
Scope of IQ:
Confirmation of the analytical equipment specifications
Confirmation of maintenance of document
Confirmation of installation site and conditions for target system
15. ANALYTICAL INSTRUMENT
QUALIFICATION (AIQ) PROCESS
OPERATIONAL QUALIFICATION (OQ)
Function according to its operational specification testing in the selected
environment.
Activities:
Fixed Parameters: non-changing parameters such as height, voltage
inputs, loads and length.
Software Configuration: Setup configuration to connect to PC and
collect data management and user management with a database.
Instrument function test: Verify the instrument can be operated as
intended by manufacturer.
16. ANALYTICAL INSTRUMENT
QUALIFICATION (AIQ) PROCESS
OPERATIONAL QUALIFICATION (OQ)
Outline of Inspection of Items and Procedure:
Wavelength Accuracy
Photometric accuracy
Stray light
Baseline flatness
UVVis 1900 Shimadzu
17. ANALYTICAL INSTRUMENT
QUALIFICATION (AIQ) PROCESS
PERFORMANCE QUALIFICATION (PQ)
To verify the performance of the instruments system meet the intended
purpose that following the user specification.
Activities:
Performance check : to verify the acceptable performance of the
instrument for its intended use.
Preventive maintenance and repairs : To ensure the instrument remains
qualified.
Practices for PQ, change control and periodic review: Documentation
18. ANALYTICAL INSTRUMENT
QUALIFICATION (AIQ) PROCESS
PERFORMANCE QUALIFICATION (PQ)
Outline of Inspection of Items:
Performing calibration
Electrode preparation
Result analysis
pH meter Mettler Toledo
