- OBJECTIVE
- To lay down a procedure for sampling of Raw Materials so as to get a representative sample of the whole lot for analysis.
- SCOPE
- This SOP shall be applicable to sampling of all Raw materials.
- RESPONSIBILITY
- Quality Control Executive/Officer
- ACCOUNTABILITY
- Head Quality Assurance
- PROCEDURE
- On receipt of the Goods Receipt Note (GRN) from warehouse, check the material detail given on GRN and note down the details of GRN in the Raw material register kept in Quality Control department. Note down the lot number, as Analytical Report Number and supplier’s lot number shall be considered as Batch Number.
- Preferably sample the material within seven days from the date of receipt of GRN.
- Prepare containers for the sample as per plan given bellow
| Type of material | Container for pooled sample | Container for Identification test |
| Powders | Plastic containers 100 ml with screw cap or Self sealing poly bags | Self sealing polybags |
| Solvents | Glass bottles of suitable capacity with glass stoppers | Cleaned and dried glass vials with rubber stoppers |
- Ensure that sampling devices (Sampling rods & sampling spatulas etc.) to be used for materials sampling, are properly cleaned and dried.
- Verify number of containers and the total quantity as shown in the GRN with the number of the container available for sampling. Ensure that each pack is affixed with an “UNDER TEST” label.
- Start the sampling laminar flow 30 minutes before starting the sampling and ensure that the pressure differential reading is within the limits specified for the respective Magnehelic gauge. If any abnormal pressure differential is observed on any of the two Magnehelic gauge, inform the Maintenance Engineer for getting it rectified. Do not perform sampling if the pressure differential is out of the limit or the laminar airflow is not in working order.
- Before the start of sampling, ensure that the sampling booth is clean and valid cleaned tag is hanged outside the sampling booth. Fill the details of the material to be sampled on the status board. Get the container of one material and of one batch at a time, shifted under Reverse Laminar Air Flow in sampling booth.
- Check the packing condition of the containers / packs and the observation in sampler remark sheet (Annexure-1). In case of any discrepancies observed on Physical condition of the material’s container, inform the Quality Assurance Manager and Warehouse In charge and note the same in Sampler Remarks Sheet.
- Physically damaged packs / containers shall be assessed for integrity of innermost packaging. If the innermost packing is found intact, then sampling shall be done and specifically the remark shall be noted in sampler’s remark sheet. If needed the container shall be placed & packed in a LDPE bag of suitable size to give extra strength to packing of container. Otherwise physically damaged packs / containers shall not be considered for sampling and the same shall be rejected.
- Mark the self sealing polybag Vials with permanent ink marker for AR. NO of the material to be sampled and number the vials serially equal to the number of the container of the Material mentioned in GRN
- Use plastic containers for sampling the material and label it with the “POOLED SAMPLE” label on container giving the details of the materials being sampled.
- Use Glass containers only for liquid raw materials. Use Glass container of such size that about 70% of volume of container suits to fill with volume of sample.
- Operate the sampling booth as per SOP for Operation and cleaning of sampling booth.
- Ensure that the containers are clean before taking them inside the Sampling Booth for sampling and open the lid / pack carefully by breaking the seals / stitching. In case any container / bag is found without seal or open stitching; enter the details in Sampler Remarks sheet.
- Observe the physical appearance of the material for any abnormality like difference of colour from the colour specified in official monograph of the pharmacopoeia, lumps, non-characteristic odour, foreign matter and physical heterogeneity in different layer of the same container and among material different container of the same batch. Record all observations in the “Sampler’s Remark Sheet” (Annexure-1).
- In case, if any abnormality is observed in a container, check and confirm whether similar abnormality is present in remaining containers. If all containers are found with similar abnormality reject the entire consignment.
- Reject the physically damaged container, and open the remaining containers found intact. If the material is found complying the physical characteristics specified in monograph of pharmacopoeia, sample the intact containers.
- Withdraw approximately 1g sample for identification test from each container of active and mark the self sealing polybag. Use fresh spatula for the sampling from each container for identification test. In case of excipients open all containers except Lactose, which is √n+1, check each containers for description compliances as per specification.
- Sample the material with the help of `spatula from each individual container except in case of Lactose IP/ BP, where the sampling is done from √n+ 1 containers. In case of any discrepancy in the description of material use sampling rod. Ensure that the weight of the sample taken is approximately equal to sample taken for analysis and reserve sample as per quantity mentioned in Annexure – 2, by weighing it on weighing balance.
- Close the containers / packs properly after sampling is over and affix duly signed “Sampled” labels on the containers. In case of failure to generate labels from BaaN the required no. of labels should be generated manually. The fixed fields shall be rubber stamped and the variable fields shall be entered manually.
- Mix the sample thoroughly and divide into different portions, for control sample and pooled sample for analysis in labelled screw cap plastic containers. In case the sample volume is more use self-sealing double polybag instead of plastic containers. Raw materials having microbiological testing shall be given to Microbiology lab.
- Place all the self sealing poly bag for identification test belonging to same GRN in a big self sealing bag and label it with appropriate detail with permanent marker. Do not preserve control sample for solvents and liquid raw materials.
- Ensure cleaning of the area for sampling of the next item, use a fresh set of spoons / sampling rods / disposable gloves, for each item while sampling.
- Bring the samples along with the Sampler’s Remark Sheet, GRN and Supplier’s Certificate of Analysis (if received) to the Quality Control Laboratory for analysis.
- Place the sample container in Dessicator meant for the samples of the raw materials in Quality Control lab and control sample in control sample room following the SOP .
- Forms and Records (Annexures)
- Format for “Sampler Remark Sheet” – Annexure-1
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control.engineering
- History
Date Revision Number Reason for Revision – 00 New SOP
Annexure-1
Format for “Sampler Remark Sheet”
|
Sampler’s Remark Sheet (Raw Materials) |
||||||||||||
| Raw Material | ||||||||||||
| A.R. No. | Batch No. | |||||||||||
| Total Number of Containers received | Number of containers sampled | Total Quantity sampled | ||||||||||
| 01 | Storage Conditions | Temperature °C | ||||||||||
| RH % | ||||||||||||
| 02 | Under Test Labels Affixed | Yes | No | |||||||||
| 03 | Packing | Outer Pack | ||||||||||
| Inner Pack | ||||||||||||
| 04 | Packing Condition
(If not satisfactory state observations) |
Satisfactory | Not Satisfactory | |||||||||
| 05
|
Supplier’s Label Verification
|
(i) | Pharmacopoeial Status | Yes | No | |||||||
| (ii) | Manufacturer’s Name | Yes | No | |||||||||
| (iii) | Batch Number | Yes | No | |||||||||
| (iv) | Date of Manufacturing | Yes | No | |||||||||
| (v) | Date of Expiry | Yes | No | |||||||||
| (vi) | Quantity | Yes | No | |||||||||
| (vii) | Container number | Yes | No | |||||||||
| (viii) | Storage Conditions | Yes | No | |||||||||
| Any other Remarks | ||||||||||||
| 06
|
Physical Appearance
|
(i) | Presence of lumps | Yes | No | |||||||
| (ii) | Abnormal odour | Yes | No | |||||||||
| (iii) | Heterogeneity in the same container or in different containers | Yes | No | |||||||||
| (iv) | Foreign matter | Yes | No | |||||||||
| Any other Abnormality | ||||||||||||
| 07 | Supplier Certificate received | Yes | No | |||||||||
| 08 | Approved Vendor | Yes | No | |||||||||
| Signature of Executive /Officer | Date | |||||||||||
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