1.0 Purpose:
All complaints must be addressed by the established procedure for sampling Raw Material.
2.0 Scope:
This SOP applies for sampling Raw Material in (name and address of the company).
3.0 Responsibilities:
Q.C. Executive/Designee: Understand and apply the procedure in practice.
Q.C. Head/Designee: To Review the SOP and its implementation.
QA Manager/Designee: To Approve the SOP.
4.0 Material and equipment:
None
5.0 Sampling of Raw Material
5.1 Precaution
5.1.1 Always use clean and dry poly bags for Sampling.
5.1.2 Mope the sampling device like a stainless steel liquid, solid sampler, and hand with 70% IPA for collecting samples for microbiological limit test.
5.1.3 One consignment of material shall be sampled at a time.
5.1.3 Different sampling devices are used for sampling different materials.
5.1.4 Wear a mask, gloves, cap, and slipper the store provides.
5.1.5 Ensure the cleaning status label is available on the sampling booth before Sampling.
5.1.6 The sampling booth shall be used for Active and Excipient materials.
5.1.7 Sampling of booth active and excipient's hygroscopic, light-sensitive raw material shall carried out on sampling booth with sodium lamp and dehumidifier facility.
5.1.8 Switching on the sodium lamp for 5 minutes before sampling the light-sensitive material.
5.9 Carry out Sampling of active and excipient material in the sampling booth.
5.1.10 Ensure that the monometer reading of the sampling booth laminar airflow unit is between 7 and 15 mm of water before Sampling.
5.1.11 All solids and liquid materials except solvents shall be sampled in the sampling booth. First, take samples for microbial testing. Then, the other Sampling
5.1.12 Receive the Material Receiving Intimation in triplicate with the store sign in charge and a physical verification report from the store. Enter the details in the raw material log register maintained separately in the Q.C. department for Active and Excipient raw materials.
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Quality Control Departmnt |
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Name of the material |
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Date of Receipt
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Supplies By |
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Batch No. |
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Mfg. Data |
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Expiry date |
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A.R. No. etc. |
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5.1.13 Assign the work of sampling the material to the Q.C. Officer.
5.1.14 Assign the sampling work to the Q.C. Officer.
5.1.15 You must check that the material is imported from an Approved Vendor.
5.2 Sampling Container
5.2.1 They should select the sample container according to the nature of the material based on the prepared and updated list.
5.2.2 For solid materials sampling, clean, fresh poly bags should be used.
5.2.3 Use a clean and dry amber glass bottle with screw caps for liquid and a transparent stoppered flask for solvent.
5.2.4 Light-sensitive samples should be sampled in a black polyethylene bag.
5.2.5 The moisture-sensitive materials should be sampled in an airtight container.
5.2.6 A sterile container should be used for Sampling for microbial tests.
5.3 Sampling Preparation
5.3.1 Before Sampling, check the details on Material Receiving Intimation with the supplier label and the material container, sacks, drum, etc.
5.3.2 Ensure the containers are cleaned externally, and their physical condition is good before bringing them to the sampling area.
5.3.3 Check whether the material falls from the approved vendor list. If not, then the material should not be sampled.
5.3.4 Note the sampling booth's differential pressure reading, temperature, and relative humidity.
5.3.5 If any discrepancy/abnormalities are observed, like a damaged container, unapproved vendor, etc., they should be immediately informed to the store charge QC Manager.
5.3.6 In the case of Active Raw Material, carry out Sampling from all containers of each supplied batch for the individual identification test for all containers.
5.3.7 In the case of all Excipient Raw Materials, Sampling is carried out from different containers in each supplied batch according to formula Vn+1.
5.3.8 If 30 containers are received, give container no. 1/30, 2/30, etc.
5.3.9 It would be best to take the sample from various container levels, i.e., the top, middle, and bottom. The sample weight should be as per the sampling plan.
5.3.10 Reseal the container after Sampling, affix the yellow color duly filed, and sign "Under Test/ Sampled" on all the containers as required for the different types of containers.
5.3.11 Place the sampling device labeled to be clean.
5.3.12 The collected sample should be transferred to the Q.C. Laboratory under supervision.
5.3.13 For Excipient Raw Materials: prepare two composite samples by taking an equal quantity of material from the sample. Mix well with a spoon in a big polyethylene bag for retained and testing samples.
5.3.14 For Active Raw Material
By taking an equal amount of material from the individual sample container. You have to prepare a composite sample for each of the ten containers of the consignment. Mix well with a spoon in a large plastic bag to train the model for the Assay test. For complete analysis and storage of the sample, prepare a composite model by taking an equal amount from each piece.
5.3.15 Make the entry of analysis done in the sampling register.
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