SOP on Sampling Quantity

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