Sampling Of Raw Material In Pharmaceuticals SOP

1.0  OBJECTIVE:

To describe the procedure for sampling of raw material.

2.0  SCOPE:

This SOP is applicable for the procedure for sampling of raw material.

3.0  RESPONSIBILITY:

3.1  Officer/Executive-Quality Control.

4.0  ACCOUNTABILITY:

4.1  Manager-Quality Control.

4.2  Head of the Department.

5.0  PROCEDURE:

5.1  Select the raw material to be sampled from under test list generate sample checklist.

5.2  Quality Control Executive informs the Q.C Chemist to sample the material from the calculated number of containers by following formula for each receiving report.

5.2.1        Each container of the batch should be sampled for active material.

5.2.2        Container to be sampled for excipients material = √n+1.

Where,

n= Number of containers received.

5.2.3        If number of containers is 3 or less than 3 (for excipients material), draw sample from each container.

5.3  Select number of containers to be sampled for excipients as per sampling plan as per given in Annexure-1.

5.4  Prepare the labels for containers to be sampled and sample bag/ container.

5.5  Prepare sampled label for containers as follows “Sampled Label” on containers packs which are selected for sampling shall be identified as N/1/n, N/2/n,....N/S/n.

Where,

N= total number of packs/ containers.

S= serial number of container selected for sampling.

n= total number of containers taken for sampling.

5.6  Prepare labels for pool sample and control sample with name of the material and batch no. refer Annexure-2 for specimen samples checklist.

5.7  Arrange to bring containers/ packs near the sampling booth. Ensure the containers are cleaned externally before taking them inside the sampling booth.

5.8  Check the labeling and physical condition of the container/ packs.

5.9  Ensure each pack bear the vender/ manufacturer’s label indicating material name, batch no., mfg. date, expiry date/ retest date and manufacturer’s name & address storage condition and other precautions/ details if any.

5.10                            Ensure that each container/ pack is affixed with “UNDER TEST”. Verify & reconcile number of containers and the total no. received as shown in the under test label.

5.11                            Check the packing condition of the containers/ packs for any damage. In case of any discrepancy, inform Q.A Manager and warehouse Manager.

5.12                            Physically damaged container shall not be considered for sampling and will be rejected at the time of approval/ rejection of the material.

5.13                            All raw materials after sampling shall be kept back to their designated place as per their storage condition.

5.14                            Sampling shall be done specially from the damaged container if found ok including other randomly selected pack or container as per sampling plan.

5.15                            Before entering in the sampling booth carry all uniform provided in the sampling area.

5.16                            Check the sampling booth cleanliness and the status label. Ensure sampling area and sampling booth should be clean and free from remaining previous raw material.

5.17                            Switch ‘ON’ the laminar flow unit of the sampling booth and get it stabilized for 15 minutes.

5.18                            Record the temperature and relative humidity of the sampling booth in the logbook and it should be in the respective range.

5.19                            Before the sampling activity affix label indication “UNDER SAMPLING” on the display outside sampling room.

5.20                            Bring the containers/ packs in the sampling booth at a time open them carefully after breaking seal/stretching.

5.21                            Material of only one batch no. shall be sampled at a time.

5.22                            Open the primary pack of the sealed container and proceed for sampling as per procedure.

5.23                            Use dedicated sampling aids for the sampling of the active ingredients.

5.24                            Observe visually appearance of the material for any abnormalities like discoloration, lumps, non-characteristic odor and presence of foreign material.

5.25                            Withdraw approximately equal quantities from the all marked containers/ packs to make the total withdraw quantity equivalent to the quantity specified for sample.

5.26                            Master copy as well as distribution copies of sample quantity will be live document and shall be maintained manually, if any new product will incorporate with approval of quality assurance.

5.27                            The following clean sampling equipment shall be used to sample different type of raw material.

Long glass tube

For liquid sampling from drum.

Glass pipette with rubber treat

For liquid sampling from bottle.

S.S Spatula

For sampling of material from small solid containers.

S.S Sampling knife/ Spoons

For sampling of solid raw materials from bags/ drums.

 

5.28                            Number of pooled sample taken for analysis depends upon the number of containers to be sampled (refer annexure-1).

5.29                            If the number of pooled sample of a particular material exceeds more than one, then assay of the individual test sample has to be performed.

5.30                            After sampling is over tie the innermost bag with cable tie and close container/ pack properly. Affix sampled labels (duly signed) on the container and send back the container to the respective storage condition.

5.31                            Check the glass material used during sampling is free from any chipping before and after sampling of each container.

5.32                            After sampling is over take out the dress given for sampling area and put them in the garment bin and remove the ‘UNDER SAMPLING’ label from area.

5.33                            Cleaning Procedure of Sampling Aids:

5.33.1    On the completion of sampling of each material ensure that the used aids are transferred in a polythene bag to avoid cross contamination.

5.33.2    The used sampling aids shall be washed with potable water using scrubber/ brush and finally rinse with purified water, wipe the sampling aids using lint free cloths.

5.33.3    Stretch wrap the sampling aids place them in the oven, switch on the oven and let the sampling tools dry.

5.33.4    Take out all the sampling aids (dried) and wrap them in polyethylene bag and keep them in the racks provided in the room.

6.0  REVISION LOG:

Revision No.

Effective Date

Reason

00

 

New SOP

 

7.0  REFERENCES:

7.1  Not Applicable.

8.0  ANNEXURES:

Annexure 1: Sampling plan for in-active material.

Annexure 2: Label Specimen.

 

Annexure: 1

Sampling plan for in-active material

No. of containers in a batch

No. of containers to be sampled

No. of pooled samples to be prepared for analysis

1-3

All containers

1

4-8

3

1

9-15

4

1

16-24

5

1

25-35

6

1

36-48

7

1

49-63

8

1

64-80

9

1

81-99

10

2

100-120

11

2

121-143

12

2

144-168

13

2

169-195

14

2

196 & above

15

2

 

Annexure: 2

Label Specimen

SAMPLED

Item name:

 

Batch no.:

 

Container no.:

-------------of-------------

Date of sampling:

 

Sampled by & date:

 

 

SAMPLE FOR ANALYSIS

Product name:

 

Batch no.:

 

Batch size:

 

Mfg. date:

 

Exp. Date:

 

Sample qty.:

 

Sampled by & date:

 


REJECTED

Material name:

 

Material code:

 

Container no.:

-------------of-------------

Batch no.:

 

Qty. of material:

 

MRN No.:

 

A.R. No.:

 

Vender:

 

Rejected by & date:

 

 

APPROVED

Name:

 

Batch no.:

 

Item code:

 

Total qty.:

 

Number of containers:

 

MRN No.:

 

Retest on:

 

LOD/ Water content:

 

Assay (ODB/OAB)

 

Analysts:

 

Sign/ date:

 

 

 

 

9.0  ABBREVIATIONS:

Abbreviation

Expanded Form

S

Standard operating procedure

&

And

%

percentage

Square root


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