Friday, December 5, 2008


To lay down a procedure for sampling of non sterile raw materials so as to get a representative sample of the whole lot for Analysis.
This SOP covers Sampling procedure of Raw material and this is applicable to Quality Control Department.
Quality control chemist/ Executive.
Department Head
5.1 GRN (Goods Received Note) Receipt procedure:
5.1.1 Switch on the computer and double click on SAP(ERP) log on. And double click on server name on the Desktop.
5.1.2 SAP initial screen will appear. Type user name and password and press enter.
5.1.3 Main menu screen will appear. To proceed further, follow the transaction:
Via Menus
User menu for F11QCRM – Quality - Customized Reports - UNDER TEST STATEMENT LIST
Via Transaction Code
Plant at which lot created
Click the field, click [down arrow] select the Place required and double click.
Date at which lot created
Click the field, click [down arrow] key & select the ‘date’ and click on ‘choose’ button. Similarly go to the other field repeat the same.
Describes what causes the lot to be created
Click the field, click[down arrow] select the required origin (01) and double click.. Similarly go to the other field repeat the same, in case you want to select more than one ‘lot origin’ type of material.
Material Type
Defines the group of materials
Click the field, click[down arrow] select the required origin (01) and double click.. Similarly go to the other field repeat the same, in case you want to select more than one ‘material type’
Radio buttons,
materials are displayed as per the status of material [Under test / Approved / Rejected..]
Select one of the desired options
Click the “Execute” icon to advance to the next screen named “Under test Statement List”, from this screen , materials of selected type, which are “under-test” Inspection lots can be seen.
5.1.5 Note down GRN date, Material name, AR NO.(Inspection lot) , In-house batch No., quantity and Vendor and Vendor Batch No.,in the register.
5.1.6 Click on the AR No. The system displays the “Display inspection lot” Screen and note down the manufacturer’s name & manufacturing batch no. from this screen.
5.1.7 Check whether the material falls under either approved supplier or not. The list of approved suppliers for the material is available in the Sampling kit.
5.1.8 If the supply of the item is from an approved vendor sampling of the material shall be done as per sampling plan given in Annexure
5.1.9 In case , the supply is from a new source ( newly approved source) , sampling shall be done from all the containers till 5 batches. Based on the feed back, sampling plan shall be decided as per Annexure.
5.2 Prepare SAMPLED labels (Annexure) for number of containers / packs selected for sampling and also for pooled sample, microbiology test (wherever required) and Control sample.
5.3 Ensure the availability of following documents and cleaned equipments for sampling
5.3.1 Sampling Spoons
5.3.2 Gloves, mask & goggles
5.3.3 Sampling bags / bottles
5.3.4 Sterile spoons / bottles.
5.3.5 Sampling of Raw Materials – Standard Operating Procedure
5.3.6 Handling of equipments – Standard Operating Procedure
5.3.7 Approved Vendor List
5.3.8 List with Quantities of Pool sample and Control sample for each material.
5.3.9 Sampler’s Remarks Sheets
5.3.10 Labels – ‘sampled’, ‘control sample’, ‘pool sample’, ‘microbiology sample’, ‘container identification sample’.
5.4 Verify and reconcile number of containers and the total quantity as shown in GRN.
Ensure that each pack is affixed with “UNDER TEST” label
[Refer Annexure for specimen label ]. Check the packing condition of containers / packs for any damages. Select the desired pack / container(s) as per sampling plan. Arrange to shift them near the sampling area. In case of any discrepancies, inform Quality Assurance Manager / warehouse In charge.
5.5 Physically damaged packs / containers shall be assessed for intactness of inner most packaging. Sampling shall be done specifically from the intact containers. Physically damaged packs / containers shall not be considered for sampling and the same shall be rejected.
5.6 Before starting sampling, ensure that the sampling area is cleared of all previous raw materials and is clean. Bring the containers / packs inside Sampling room after breaking seals.. Ensure that containers are clean externally before taking them inside the Sampling Booth.
5.7 Sampling procedure :
5.7.1 Observe visually appearance of the material for any abnormality like discoloration, lumps, non-characteristic odour, foreign matter and physical heterogeneity.
5.7.2 In case of any abnormality observed, reject the entire consignment.
5.7.3 Record all observations in “Sampler’s Remark Sheet” (Annexure)
5.7.4 Withdraw approximately equal quantities from all marked containers / packs for preparing pooled sample by using clean spoon / Sampling rod / Augers. Label the bottle / polybags in which samples are taken with appropriate pool sample labels.
5.7.5 Samples for microbiological testing wherever applicable shall be collected in a previously sterilized sample container.
5.7.6 Close containers/packs after sampling is over properly. Affix “SAMPLED LABEL” on containers / packs which are selected for sampling identified as N/1/n, N/2/n, ... N/S/(‘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).
5.7.7 `For Active Ingredients retain the portion of sample for analysis in individual bags
/ containers. Mix the remaining sample thoroughly and transfer in a bottle as per the quantity mentioned in Analytical Specification of the material for Control Sample.
5.7.8 Label shall be affixed on sample bottle/ poly bags as Control sample. [Refer Annexure for
specimen label]
5.7.9. For Excipients, mix the pooled sample thoroughly and divide it into two sets and transfer
in bottle / poly bag per the quantity mentioned in Analytical Specification. Label shall
be affixed on sample bottles/poly bag as pool sample and Control sample. [Refer Annexure for specimen label]
Enter the sampling time in sampling log sheet( Annexure).
5.8 Clean the Area after sampling of every material. Enter the cleaning time in cleaning log
for sampling Room. (Annexure)
5.9 Fill relevant details in Analytical Report from Annexure.
6.0 Bring samples along with sampler’s remark sheet, and supplier’s certificate of analysis (if received ) to Quality Control Laboratory for analysis.
7.0 Ensure cleaning of area for sampling of next item. Use fresh set of spoons / sampling rods for each item while sampling.
7.10 Use always clean dry bottles with screw caps for collecting liquid samples and fresh poly bags / bottles for solids.

No comments: