master of good manufacturing practice - course details
TRANSCRIPT
© SeerPharma Pty LtdThis presentation is copyright to SeerPharma Pty Ltd and may not be modified,
reproduced, sold, loaned, hired or traded in any form without the express written permission of SeerPharma Pty Ltd, SeerPharma (Singapore) Pte Ltd or its subsidiaries.
Post Graduate Courses in Good Manufacturing Practice
SP6506-1 Ver 1.0 2
Product Quality and Patient Safety – What Went Wrong?
Counterfeit Heparin Blamed
for 200 Worldwide Deaths Diethyl glycolcontaminates…
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Regulator View – Why do we need cGMPs?
• A product is deemed adulterated “if the methods used in, or the facilities or the controls used for, its manufacture, processing, packing or holding do not conform to or are not operated or administered in conformity with current good manufacturing practices.* “
• * Good manufacturing practices require processes to be in a state of control.
USA - FD&C Act Section 501 (a) (2) (B)
HES6402-2A Ver 3.33
Define Quality Characteristics
• In general terms Quality can be defined as:
– Purity
– Identity
– Effectiveness
– Safety
HES6402-2A Ver 3.34
Current International GMP Regulations
HES6401-1 Ver 7.0 5
© SeerPharma Pty LtdThis presentation is copyright to SeerPharma Pty Ltd and may not be modified,
reproduced, sold, loaned, hired or traded in any form without the express written permission of SeerPharma Pty Ltd, SeerPharma (Singapore) Pte Ltd or its subsidiaries.
Pharmaceuticals TodayA global supply business
> 75% of all APIs originate from outside the USA …
6HES6401-1 Ver 7.0
HES6401-1 Ver 7.07
PICS Guide To GMP (International Rules)
Part I ( Basic Requirements for Medicinal Products)
CHAPTER 1 - QUALITY
MANAGEMENT
CHAPTER 2 - PERSONNEL
CHAPTER 3 - PREMISES AND
EQUIPMENT
CHAPTER 4 - DOCUMENTATION
CHAPTER 5 - PRODUCTION
CHAPTER 6 - QUALITY CONTROL
CHAPTER 7 - CONTRACT
MANUFACTURE AND ANALYSIS
CHAPTER 8 - COMPLAINTS AND PRODUCT RECALL
CHAPTER 9 - SELF INSPECTION
FDA Drug Manufacturing Inspections Program (CPG 7356.002)
1. Quality System. • Change control, reprocessing, batch
release, • Annual product review • Validation protocols, • Product defect evaluations• Evaluation of returned and salvaged drug
products.
2 . Facilities and Equipment System. • Buildings and facilities along with
maintenance• Equipment qualifications (IQ/OQ); • Equipment calibration and preventative
maintenance; • Cleaning and validation of cleaning
processes. • Utilities - HVAC, gases, steam and water.
3. Materials System. • Control of finished products, components,
water, gases, • Containers and closures. • Validation of computerized inventory
control • Drug storage, distribution controls, and
records.
4. Production System. • Batch compounding, dosage form production, • In-process sampling and testing, • Process validation. • Master batch records and manufacturing
procedures.
5. Packaging and Labeling System. • Packaging and labeling operations & controls • Label examination and usage, • Label storage and issuance,• Validation of these operations.
6. Laboratory Control System. • laboratory procedures, • testing, analytical methods development • Method validation or verification, • Stability program.
8HES6401-1 Ver 7.0
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Practices to Prevent Product Adulteration
• Procedures and Documentation
• Frequent in-process QC checks
• Detailed Training (GMP and Skills) and Supervision
• Managers & Supervisors - Follow the Rules and Instructions,
set the example.
• Double -check and certify all critical process steps
• Accurate Yield and Reconciliations with action limits
HES6402-2A Ver 3.39
Practices to Prevent Product Adulterationcont.
• Conduct and Verify Line Clearances
• Segregate Product and Operations wherever possible
• Validate and document Cleaning and Sanitation Programs
• Raw Materials, Environmental and Personnel Control
• Be Careful!
• Open communications between managers and staff. Report
deviations
HES6402-2A Ver 3.310
SP6506-1 Ver 1.0
Collaboration
- SeerPharma has developed the courses and will deliver them using experts in the field of GMP www.seerpharma.com.au or email [email protected]
- Labnetworx is the Indian based partner who will market the courses to Pharmacy Colleges, Pharmaceutical Companies and Agents in India (Dr Sunil Tadepalli/Bhumika Fialoke) www.labnetworx.com or email [email protected]
- University of Technology Sydney (UTS) has accredited the courses in Australia and will provide the qualifications. The courses will be delivered on campus in Sydney, Australia www.gmp.uts.edu.au or email UTS staff [email protected] 11
SP6506-1 Ver 1.0
Course Structure
- 2 year Masters full time
- 1 year diploma full time
- 6 months certificate full time
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SP6506-1 Ver 1.0
Course Structure
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First Year Autumn (Semester 1) CPs
96057 GMP for Manufacturing Operations 6
96058 Validation Principles 6
96059 International GMPs and Quality Assurance 6
96060 Good (Quality Control) Laboratory Practices 6
Example of Subject Content
First Year Autumn (Semester 1)96057
GMP for Manufacturing Operations
1. Knowledge and Understanding Evaluate various options for production controls and their validation
requirements from a risk management perspective; Assess the design and effectiveness of GMP documentation against
regulatory standards and guidelines.2. Discipline Skills Evaluate production and packaging GMP compliance, including the
assessment of risks associated with processes.3. Personal Transferable Skills Evaluate data and identify facts Work effectively as part of a team Demonstrate oral and written communication skills Research, assess, evaluate and present information
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SP6506-1 Ver 1.0
Course Structure
First Year Spring (Semester 2) CPs
96069 Contamination Control 6
96062 Good Aseptic Practices and Sterile Products 6
96063 GxP and Quality Auditing Practices 6
96064 Risk Management for Pharmaceutical Operations 6
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SP6506-1 Ver 1.0
Course Structure
Second Year Autumn (Semester 1) CPs
96065 Process Development for Therapeutics – A Perspective for Finished Dose Forms 6
96066 Clinical Trials Quality Assurance Management 696067 Supply Chain Management 696068 Industrial Research Project A 6
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SP6506-1 Ver 1.0
Course Structure
Second Year Spring (Semester 2) CPs96061 Computer Systems Validation Principles and
Practices 6
96070 Process Development for Therapeutics – A Perspective for Medical Devices 6
96071 Validation Practices 696072 Industrial Research Project B 6
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