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
Officer/ Executive - Quality Control4.0 ACCOUNTABILITY
Manager – Quality Control5.0 PROCEDURE
5.1 Select the raw material to be sampled from under test list and generate samples checklist.5.2 Quality Control Executive informs the QC 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 excipient material = √n+1
5.2.3 Where n = Number of containers received.
5.2.4 If number of containers is 3 or less than 3 (for excipient material), draw sample from each container.
5.3 Select number of containers to be sampled for excipient as per sampling plan as per given in Annexure-I.
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 (N Stands for total number of packs/containers, `S` for serial number of container selected for sampling and `n` for total number of containers taken for sampling)
5.6 Prepare labels for pool sample, control sample, and microbiological sample (whenever required) with name of material and batch no. Refer Annexure-II 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 number, manufacturing date, expiry date /retest date and manufacturer's name & address storage condition and other precautions/details if any.
5.10 Ensure that each containers/pack is affixed with “UNDER TEST”. Verify & reconcile number of containers and the total number received as shown in the under test label.
5.11 Check the packing condition of the container’s/packs for any damages. In case of any discrepancy, inform QA manager and Warehouse manager.
5.12 Physical 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 okay 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.
5.17 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/pack 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 thief/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 I).
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 perform.
5.30 Sample for microbiological testing wherever applicable shall be collected into sterilized sampling container.
5.32 Check the glass material used during sampling is free from any chipping before and after sampling of each container.
5.33 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.
5.34 Cleaning Procedure of Sampling Aids
5.34.1 On the completion of sampling of each material ensure that the used aids are transferred in a polythene bag to avoid cross contamination.
5.34.2 The used sampling aids shall be washed with potable water using scrubber /brush and finally rinse with purified water wipe the sampling aids using a lint free cloths.
5.34.3 Stretch wrap the sampling aids place them in the oven, switch on the oven and let the sampling tools dry.
5.34.4 Take out the all the sampling aids (dried) and wrap them in polythene bag and keep them in the racks provided in the room.
5.35 Sampling of Sterile Material
6.36.1 Before transfer the material to sampling booth following precaution is to be taken.
5.35.1.1 Remove all external packing material like cartons, shippers.
5.35.1.2 Remove all deposited dust with a lint-free cloth.
5.35.1.3 Clean the container with 70 % IPA solution.
5.35.1.4 Before transfer to airlock assure the container is properly clean.
5.35.1.5 Again clean the container with 70 % IPA under class D area.
5.35.1.6 Leave the container under UV light for 4 hours.
5.35.1.7 Finally transfer the container Under LAF.
5.36.2 Entry to the LAF room (Sterile Sampling Booth) and collection of sterile material.
5.36.2.1 Follow entry to sampling area as per SOP
5.36.2.2 Run the LAF and put the container under LAF.
5.36.2.3 Collect the sterile sampling bottle and stainless steel spatula.
5.36.2.4 Put all sampling aids in a sterile tray for sampling under LAF
5.36.2.5 Do the samplings of material aseptically as per sampling procedure.
5.36.2.6 Close the container as well as sampled sample aseptically.
5.36.2.7 Assure the sealing of container maintain sterility level.
5.36.2.8 Transfer the container to warehouse quarantine area.
5.36.3 Exit from the Sampling area
5.36.3.1 Switch ‘OFF’ the LAF and leave the area after sampling.
5.36.3.2 Put-off the sterile garment, gloves and slippers in airlock.
5.36.3.3 Wear the area garments.
5.36.3.4 Come out of the change room.
5.36.3.5 Wash the hand with soap solution followed by disinfectant.
5.36.3.6 Used garment is to send for washing and disinfection.
6.0 ABBREVIATIONS
6.1 SOP - Standard Operating Procedure6.2 LAF - Laminar Air Flow
6.3 IPA - Isopropyl Alcohol
6.4 UV - Ultra Violet
6.5 SS - Stainless Steel
ANNEXURE- 1
SAMPLING PLAN FOR IN-ACTIVE MATERIAL
Number of containers in a batch
|
Number of containers to be sampled
|
Number 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- II
SPECIMEN LABELS
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