Staff who hold postgraduate degrees in Good Manufacturing Practice (GMP) are essential for many pharmaceutical, biologic, medical device and food manufacturing companies.
This presentation provides an overview of the Master of Good Manufacturing Practice offered at the University of Technology, Sydney (UTS) in Australia. For more information visit www.gmp.uts.edu.au
2. Product Quality and Patient Safety – What
Went Wrong?
Counterfeit Heparin Blamed for
200 Worldwide Deaths
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3. 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
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control.
USA - FD&C Act Section 501 (a) (2) (B)
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4. Define Quality Characteristics
• In general terms Quality can be defined as:
– Purity
– Identity
– Effectiveness
– Safety
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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
8. 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.
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9. 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,
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set the example.
• Double -check and certify all critical process steps
• Accurate Yield and Reconciliations with action limits
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10. Practices to Prevent Product Adulteration
cont.
• 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
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Collaboration
- SeerPharma has developed the courses and will deliver them
using experts in the field of GMP www.seerpharma.com.au or
email david.spaulding@seerpharma.com.au
- 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 bhumika.fialoke@labnetworx.com
- 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
international@uts.edu.au
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Course Structure
- 2 year Masters full time
- 1 year diploma full time
- 6 months certificate full time
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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
14. 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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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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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 6
96067 Supply Chain Management 6
96068 Industrial Research Project A 6
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Course Structure
Second
Year
Spring (Semester 2) CPs
96061 Computer Systems Validation Principles and
Practices
6
96070
Process Development for Therapeutics – A
Perspective for Medical Devices
6
96071 Validation Practices 6
96072 Industrial Research Project B 6
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Editor's Notes
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HIDEN SLIDE. Not for printing
SAY: here are some problems that have created headlines in recent years
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This slide is just to introduce the first part of this module.
Some background reading for the presenter:
The first modern code of Good Manufacturing Practices, as we recognize them today, were the regulations issued by the Canadian Specifications Board of the Supply and Services Department in 1957 used to assure that drugs supplied to the Canadian Military met quality specifications.
Following the success of that regulation, GMPs started being issued by regulatory agencies at a rapid pace
the US FDA issued its first version of the GMPs in 1963, the current version of the US GMPs drafted in 1973 and issued in 1976.
The British GMPs drafted in 1968 were finalized and issued in 1973, in a rush following the Davenport incident.
By the early 1980s distinct GMP codes had been issued by over 25 different countries - following the basic US or British GMP in outline, but typically adding a local wrinkle to the requirements.
EG the British and US codes required that when an error is made in data entered in a record, correction of the error shall constitute four steps: placing a single line through the error, entry of the correct data alongside the original erroneous error, entry of the signature or the initials of the person making the change and the date that the change was made. The Australian GMPs added the requirement that in addition the reason the error had originally been made also needed to be entered in the record; the Japanese added the requirement that the strike-out be made with two lines, drawn in parallel. With the exception of the Japanese Code of GMP, the GMP codes all followed the same style, had similar texts, and made approximately similar demands of pharmaceutical manufacturers in the control of manufacture and laboratory testing.
The real challenge for the both the pharmaceutical industry and the regulators is that products can be developed in one country, triallled in another, manufactured in yet another country, finished (or packed) somewhere else and then sold in a different country again. Give an example from big pharma.
Little wonder that, in this global environment, regulations and regulatory expectations are changing.
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This is an example of a Compliance Policy Guidance (see slide 30 FDA Regulatory Control Mechamisms). Note that it binding on the inspectors but not on industry. Tell inspectors how to inspect. QSIT is device equivalent