STANDARD OPERATING PROCEDURE Title: Sampling of Raw Material

1. PURPOSE

• It is established to provide the guidelines for the sampling of raw material.
2. SCOPE
• It is applicable to all types of incoming material.
3. RESPONSIBILITY
• Quality Control Manager
• Quality assurance Officer
4. PROCEDUR
ITEMS REQUIRED FOR SAMPLING:
1. Spatulas
2. Pipettes
3. Tissue Paper
4. Glass vials
5. Glass bottles with screw caps
6. Dusters
7. Labels
8. Glass bottles
9. Raw material receiving receipt
10. Polythene bags (sample size)
1. Upon receipt of raw material the warehouse Incharge will issue a respective
Goods receiving report, by which the Quality assurance Department will be requested to collect samples for analysis and retaining samples.
The Warehouse Incharge will also affix raw material Quarantine slips with all necessary information on each container together with a label, date of sampling, name of person and signature.
2. Before sampling the following points should be checked:
 Condition of the container. It should not be damaged, torn, contaminated with dust, water etc.
 Incase of any abnormalities, all details should be noted on Raw material receiving receipt.
 In any damaged / Deteriorated case of insured imported material, the supervisor should be informed immediately to note down the location & condition of damaged material container(s). In such case the container should be opened on the presence of supervisor.
3. Sampling should be carried out according to the formula


4. Availability of certificate of analysis of imported materials should be confirmed.
5. In case of consignment does not bear any batch number/lot number, the whole consignment would be considered as one batch.
6. Put serial number on all containers.
7. Solid Materials
With the aid of a spatula take three samples from the same container from top to bottom, collect in a suitable air tight container.
8. Semi Solids:
Stir the content of the container to mix thoroughly. Insert a Stainless steel rod from top to bottom in the material. Collect the material sticking to rod, in a suitable jar.
9. Liquids:
Stir the content of the container to mix and take sample with the pipette or a suction pump. Collect in a suitable bottle.
10. After sampling all containers should be properly closed or sealed and labeled.
11. Identification on each container and mixed assay to be carried out.
12. Mix the samples taken from one batch. This sample also serves as retaining sample.
13. After analysis, released label or rejected label, whichever applicable, should be affixed the Quarantine Label.
14. Released label must bear the due date for re-analysis.
Standard sample quantity for each sampling container is as follow:
I. Solids = 10 g regarding batch / lot size.
II. Semi solids = 10-5- g.
III. Liquids = 100 ml.
IV. Active = 5 g


5. QUALITY RECORD(s)/FORM(s)
The following Quality Records shall be generated and managed in accordance with the procedure for Control of Company Quality Records (4.12).

Required Record Form Reference No.
Request for analysis (Raw material) QF/064/01
Raw Material Receiving Receipt QF/013/01
Sampled QF/059/01
Under Test QF/057/01
Quarantined QF/083/01