Governing Bodies for Quality Approval
1. FDA
- Product CGMP
Governing Bodies for Quality Approval
2. Halal
-Product okay for Muslim population
(no meat in the ingredients)
Governing Bodies for Quality Approval
3. ISO (system)
International standard organization
ISO 9000 -
9001 -
9002 -
9003 -
9004 -
Governing Bodies for Quality Approval
4. HACCP
Hazard analysis and critical control point
PITFALLS in the QUEST for QUALITY
1. Instant results
- No quick fix to the quality problem
- It needs to work and think
PITFALLS in the QUEST for QUALITY
2. Lack of commitment by Management
-Effort by everyone in the company.
-Management will lead the way.
PITFALLS in the QUEST for QUALITY
3. Lack of long term planning
4. Limited application
5. Overdependence on computerized QC
PITFALLS in the QUEST for QUALITY
6. No market research
- Quality that is expected by the market.
PITFALLS in the QUEST for QUALITY
7. Lack of funds for quality process
-On the training
-Hiring qualified personnel
-Long term plan
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
PITFALLS in the QUEST for QUALITY
9. Failure to acquire statistician/ consultants
-Hire consultant to train the workforce.
PITFALLS in the QUEST for QUALITY
10. Failure to involve suppliers
- Quality of incoming goods must be equal to quality of the product.
6/24/15
1. Sampling PLAN2. Manufacturing, Packaging,
Distribution control3. Statistical Quality Control
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.
SAMPLE
• Taking a portion of a population for testing and analysis. The result therefore will represent the batch population.
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
Steps involved in developing a sample plan
2. Design a sampling scheme that details how and when samples will be taken.
Steps involved in developing a sample plan
3. Select a sample size
Ex.
50s
100s
200s or more
Steps involved in developing a sample plan
4.Design data storage formats
Steps involved in developing a sample plan
5. Assign roles and responsibilities
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.
Storage limit
• 6 months - vitamins and flavors
• 12 months - active ingredients and dyes
• 24 months - active ingredients and excipients
Materials Control
1. Raw materials
2. Stickers
3. Printed and packaging materials
4. Labelling control
5. Containers
6. Reassay
Material control
1. Manufacturing monograph
2. Quality control monograph
3. Batch records
4. Standard operating procedures
-Master formula record
-batch reproduction record
-actual tests
• 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
Material control
7. Identification test for active ingredients and possible contaminants
8. Visual appearance
9.Odor
10.Taste
11. Texture
12. Hardness
Material control
13.Friability
14. Powder finenes
15. Moisture content
16. Humidity effect
17. Color stability
18. Storage condition
Material control
19. Microbiological burden
20. Thickness
Packaging control
• Products
• Containers
• Strips and pouches
• Closures
• Labels
• Package insert
Packaging control
• Printing - control code/ expiration date
• Accessories
• Product unit
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