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20 Cards in this Set
- Front
- Back
- 3rd side (hint)
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6 components of standards and specifications |
Formula Raw material inspection SOP Finished product specification Packaging material standard Testing methods |
FRS FPT |
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4 components of Formulation |
Weight Formula Percentage Product ingredients |
WFPP |
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2 components of Raw Material Specification |
Permissible range of purity Characteristics |
PC |
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2 components of SOPs |
Step by step method Information and instruction |
SI |
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5 components of Finished Product Specification |
Stability Safety Purity Proper performance Characteristics |
SSPPC |
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This should be set for everything that goes around the product |
Packaging material standard |
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Purpose of Testing Methods |
Assure conformity to standards |
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4 characteristics of Testing methods |
Simplicity Accuracy Relevance Speed |
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3 classifications of Defect |
Measurability Seriousness of gravity Nature |
MSN |
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2 defects under measurability |
Variable defect Attribute defect |
VA |
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2 defects under seriousness or gravity |
Major defect Minor defect |
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3 defects under nature |
Ocular defect Internal defect Performance defect |
OIP |
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4 sources of variation |
Materials Machine Methods Men |
MMMM |
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5 control of quality variation |
Material control GMP Packaging Control Automation Statistical sampling plans |
MGPAS |
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SMART |
Specific Measurable Attainable Realistic Time bound |
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4 tablet defects 1 |
Capping Lamination Cracking Chipping |
CLCC |
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5 tablet defects 2 |
Sticking Picking Mottling Double impression Binding |
SPMDB |
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4 suspected defective product form 1 |
Name of product Source Strength and DF Registered number |
NSSR |
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4 suspected defective product form 2 |
Batch/lot number Expiry date Nature of defect Account of any action taken |
BENA |
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Ha |
Ha |
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