SOP on Sampling Quantity
SOP on Sampling Quantity
1.0 Purpose: This SOP describes the minimum quantity of a sample to be collected for analysis.
2.0 Scope: This SOP is applicable to all the raw materials, semi-finished and finished products, packaging components and water samples.
3.0 Responsibility: Quality Control Chemist to ensure that the procedure is followed.
4.0 Materials and Equipment:
4.01 Sampling tools i.e. spoons, sample sticks, pipette etc.
4.02 Polythene bags
4.03 Glass/ plastic/ SS containers for samples
5.0 Procedure: To control the quality of raw materials, semi-finished or finished products and packaging components, sampling is used because inspection of the whole lot is neither possible nor desirable. A representative sample of a sufficient quantity is chosen at random. If the chosen sample shows that the variations are within the tolerance limit, then the lot is accepted otherwise, it is rejected. The sample quantities are fixed on the basis of tests required but in case of Cyanocobalamin & Vitamin D3, and other highly potent API’s a small quantity may be drawn.
Table – I: For Raw Materials
|
Type |
Quantity For |
Total Quantity |
|
|
Testing |
Retention |
||
| Active |
7.0 gm |
3.0 gm
|
10.0 gm |
| Inactive |
10.0 gm or more |
—
|
10.0 gm or more |
| Hard Gelatin Capsules shells
|
300 Nos. |
— |
300 Nos. |
Table – II: For Packaging Components
|
Type |
Quantity For |
Total Quantity |
|
|
Testing |
Retention |
||
| Foil – Printed / Plain |
1 meter |
—
|
1 meter |
|
Printed Carton / Label |
5 Nos. |
—
|
5 Nos. |
| Pilfer Proof Caps
|
10 nos. |
— |
10 Nos. |
| Shipper
|
1 No. |
— |
1 No. |
| Empty bottles & measures |
5 Nos. |
— |
5 Nos. |
Table – III: Semi – Finished / Finished Products
|
Type |
Quantity For |
Total Quantity |
||
|
Bulk Testing |
Finished Product Testing |
Retention Sample |
||
|
Capsules |
10.0 gm |
40 Capsules
|
100 Capsules |
10.0 g +140 Capsules |
|
Dry Syrup |
10.0 gm
|
2 Bottles |
4 Bottles |
10.0 g + 6 Bottles |
|
Syrup & Suspension |
100.0 ml |
2 Bottles |
4 Bottles |
100.0ml + 6 Bottles |
|
Tablets
|
10.0 gm |
40 Tablets |
100 Tablets |
10.0g + 100 Tablets |
Table – IV: For Water (Raw, Purified, Drinking Effluent or Trace Analysis)
|
Type |
Quantity For |
Total Quantity |
|
|
Testing |
Retention |
||
| Raw Water |
2 x 500 ml |
—
|
2 x 500 ml |
| Purified Water |
2 x 500 ml |
—
|
2 x 500 ml |
| Drinking Water
|
2 x 500 ml |
— |
2 x 500 ml |
| Effluent Water
|
2 x 500 ml |
— |
2 x 500 ml |
| Trace Analysis Water
|
500ml from one equipment |
— |
500ml from one equipment |
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