governing bodies to sampling plan
TRANSCRIPT
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Governing Bodies for Quality Approval
1. FDA
- Product CGMP
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Governing Bodies for Quality Approval
2. Halal
-Product okay for Muslim population
(no meat in the ingredients)
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Governing Bodies for Quality Approval
3. ISO (system)
International standard organization
ISO 9000 -
9001 -
9002 -
9003 -
9004 -
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Governing Bodies for Quality Approval
4. HACCP
Hazard analysis and critical control point
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PITFALLS in the QUEST for QUALITY
1. Instant results
- No quick fix to the quality problem
- It needs to work and think
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PITFALLS in the QUEST for QUALITY
2. Lack of commitment by Management
-Effort by everyone in the company.
-Management will lead the way.
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PITFALLS in the QUEST for QUALITY
3. Lack of long term planning
4. Limited application
5. Overdependence on computerized QC
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PITFALLS in the QUEST for QUALITY
6. No market research
- Quality that is expected by the market.
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PITFALLS in the QUEST for QUALITY
7. Lack of funds for quality process
-On the training
-Hiring qualified personnel
-Long term plan
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PITFALLS in the QUEST for QUALITY
8. Underestimating the workforce
-open communication
-Everyone’s input is important, wanted and expected
-Utilize the skills and knowledge involved in the process
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PITFALLS in the QUEST for QUALITY
9. Failure to acquire statistician/ consultants
-Hire consultant to train the workforce.
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PITFALLS in the QUEST for QUALITY
10. Failure to involve suppliers
- Quality of incoming goods must be equal to quality of the product.
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6/24/15
1. Sampling PLAN2. Manufacturing, Packaging,
Distribution control3. Statistical Quality Control
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Sampling Plan
• Detailed outline of which measurement will be taken at what times
• Resulting data will contain a representative sample of the parameters of interest and allow for all questions as stated in the goals to be answered.
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SAMPLE
• Taking a portion of a population for testing and analysis. The result therefore will represent the batch population.
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Steps involved in developing a sample plan
1. Identify the parameters to be measured
Example
- Range of possible values
- Required solution
- Weight of the drug product
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Steps involved in developing a sample plan
2. Design a sampling scheme that details how and when samples will be taken.
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Steps involved in developing a sample plan
3. Select a sample size
Ex.
50s
100s
200s or more
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Steps involved in developing a sample plan
4.Design data storage formats
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Steps involved in developing a sample plan
5. Assign roles and responsibilities
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Materials Control
-System for checking that a company has enough materials in stock for its production needs but is not storing more than it needs.
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Storage limit
• 6 months - vitamins and flavors
• 12 months - active ingredients and dyes
• 24 months - active ingredients and excipients
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Materials Control
1. Raw materials
2. Stickers
3. Printed and packaging materials
4. Labelling control
5. Containers
6. Reassay
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Material control
1. Manufacturing monograph
2. Quality control monograph
3. Batch records
4. Standard operating procedures
-Master formula record
-batch reproduction record
-actual tests
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• SOLID PREPARATION
1. Assay for active ingredients
2. Assay for degradation products
3. Disintegration
4. Dissolution/ bioavailability
5. Content uniformity
6. Weight variation
Material control
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Material control
7. Identification test for active ingredients and possible contaminants
8. Visual appearance
9.Odor
10.Taste
11. Texture
12. Hardness
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Material control
13.Friability
14. Powder finenes
15. Moisture content
16. Humidity effect
17. Color stability
18. Storage condition
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Material control
19. Microbiological burden
20. Thickness
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Packaging control
• Products
• Containers
• Strips and pouches
• Closures
• Labels
• Package insert
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Packaging control
• Printing - control code/ expiration date
• Accessories
• Product unit