Sampling of Raw Materials for analysis
1.0 OBJECTIVE
1.1 To lay down procedure for Sampling of Raw Materials for analysis.
2.0 SCOPE
2.1 This SOP is applicable to all Raw Materials received
3.0 RESPONSIBILITY
3.1 QC Officer or QC Executive
4.0 ACCOUNTABILITY
4.1 QC Manager
5.0 Procedure
5.1.1 Receive the GRN (Goods Received Note) from Raw material Stores and make necessary entries in the raw material inward register.
5.1.2 Prepare the Raw material folder for the material received and fill the product details.
5.1.3 The concerned person shall take the RM folder and proceed for sampling.
5.1.4 Check the cleanliness of the sampling room.
5.1.5 Take the cleaned sampling devices, self-sealing bags or bottles, gloves and nose mask, labels etc.
5.1.6 Ensure that the sampling device ‘s cleaned.
5.1.7 Take the containers inside and inspect the same for cleanliness and physical conditions. Take one batch one product at a time into sampling room.
5.1.8 In case of any discrepancies inform the Manager QC and do the sampling only after the clearance from Manager QC.
5.1.9 Arrange the containers for sampling.
5.1.10 In case of active ingredients carry out the sampling as follows.
5.1.11 Sample all the containers.
5.1.12 Use appropriate sampling and safety devices.
5.1.13 Check the material for the compliance as per the specification for description, colour, other physical characteristics.
5.1.14 Insert the sampler and withdraw the sample.
5.1.15 Collect about 100-500mg samples in a small poly bag for unit identification purpose and labeled the bag with product and container number details.
5.1.16 Collect the balance quantity into big polythene bag for composite sample purpose.
5.1.17 Repeat the operation for further containers of the batch and collect the composite sample in composite sample bag.
5.1.18 Mix the composite sample and take the required quantity of samples (Analysis sample, control sample and out lab samples) in a poly bag (Self sealing) with sample label duly filled.
5.1.19 Close the bags and containers and paste under test label.
5.1.20 Put signature and date on the under-test label.
5.1.21 Remove the containers from sampling area.
5.1.22 In case of excipients carry out the following procedures:
5.1.23 The sampling of the under test label excipients carried out on site . Select a number of containers for sampling which shall be not less than n+1, where ‘n’ is the total number of containers received.
5.1.24 Open the selected containers and check for description, colour, other physical characteristics and black particles or any abnormal properties.
5.1.25 Using an appropriate sampler, collect the samples from each container selected and makes a composite sample, mix.
5.1.26 Take appropriate quantity from the composite sample in a self-sealing sample bags.
5.1.27 Close the containers and paste under test label.
5.1.28 Mix the composite sample and take the required quantity of samples (Analysis sample, control sample and out lab samples) in a poly bag (Self sealing) .
5.1.29 In case the sampling is required for Microbiology analysis, then sanitize the sampling device with 70% IPA and air-dry. During sampling, separately collect sample for microbiological analysis from the composite sample and identity accordingly.
5.1.30 For sampling the solvents use liquid sampler and collect sufficient samples from different levels of the container.
5.1.31 Solvent shall be sampled at the place of storage.
5.1.32 Shake the drums by tumbling before sampling and collect samples in clean dry bottles, for analysis only.
5.1.33 Check the samples for any foreign particles, colour or any phase formation (contamination).
5.1.34 Close the containers and paste under test label.
6.0 ABBREVIATIONS
| Abbreviation | Extended Form |
| QC | Quality Control |
| SOP | Standard Operating Procedure |
| mg | milligram |
| gm | gram |