Standard Operating Procedure for Sampling of Raw Materials

1. OBJECTIVE:

To lay down a procedure for sampling of raw materials.                                  

• SCOPE:

This procedure is applicable for procedure for sampling of raw materials.

• RESPONSIBILITY:

QC Officer/ QC Executive

• ACCOUNTABILITY:

QC Manager.

•  PROCEDURE:
  • Requirements:
    • Cleaned Bottles/Polyethylene bags, spatula/sampling rod, rubber band, nylon thread, scissors, pipette, hand gloves, safety goggles, drum openers, sampling labels etc.
  • Procedure:
    • Preparation for Sampling
      • Upon receiving Sample advice Note from Store department, take entry in Raw material inward register
      • Check “Cleaned and ready for use” dedicated sampling accessories:
      • Sampling rods, sampling pipettes, spatulas etc.
      • Amber glass sampling bottle – duly washed, dried and capped with caps.
      • Surgical hand gloves, masks and protective safety gear.
      • Self sealing polythene bags.
      • Sterile bottles, and sterile accessories – for sample involving microbiological testing.
      • Affix the sample label on a sample bag.
    • Method of Sampling:
      • Bring the Cleaned and ready for use sampling accessories, sampling observation sheet, Sample advice note etc. in Raw material stores and enter in the area as per respective area entry procedure.
      • Check approved vendor list and physically inspect all the bags/Containers and cross check the details on the bags/Containers with Sample advice note and record in the “Raw Material sampling check list”.
      • If any bag/Container are found damaged or any irregularities observed then inform to QC manager to take corrective action.
      • Give specific no. to all the bag(s)/Container(s) to be sampled like 1/n, 2/n…….n/n. (Where n = no. of bag/container).
      • Bring all the bag(s)/Container(s) to be sampled in sampling area through pass box provided; under RLAF.
      • For active materials 100% container should be sampled & for inactive or excipients material √n+1 container should be sampled, if 100 container received, minimum 11 container open. If received the inactive material containers received less than or equal to 5 containers; 100% container should be sampled.
      • Wear surgical hand gloves, mask i.e. protective gear etc.
      • Check cleanliness of “Sampling Booth” and area, and switch ON the LAF at least 30 minutes before sampling operation.
      • For material sensitive to light, use subdued light, and to moisture – Open the container for shortest time possible under proper RH Control.
      • Open all the bag(s) / Container (s) one by one under RLAF and check the inner container (i.e. inner lining – polythene bag for any abnormality) i.e. whether damaged or satisfactory. If material is found in the outer container then inform to QC manager.
      • Take the sample of each container for active materials in separate sample bag for identification test & one set of composite sample for complete analysis as per standard specification.
      • Draw sample by piercing the sampling rod, slit in closed position, up-to bottom of the container. Then open the slit of inner rod, by rotating the inner rod to match with outer covers slit and slightly rotate the sample rod, to draw sample from the top to bottom layers of the container’s raw material.
      • Close the slit again by rotating the inner shaft of sampling rod and then pull it out.
      • Draw individual container wise sample separately for identification purpose and paste the ‘Sampled’ stamp on sampled containers only and ‘Under Test’ labels on sample container as per Reference SOPs.
      • “Under Test” label affix whole container of the lot and “Sampled” stamp, stamped on only opened container which in take the sample.
      • Draw the individual container material for identification purpose and pooled the individual containers’ material for testing and control sample purpose.
      • Collect the sample suitably in a new self sealing poly bag or dried vial and Paste/attach Sample for testing status label on each sampled poly bags/vial with number individual identification number according to Bags/containers.
      • Close the containers inner and outer immediately without much delay.
      • For sampling the liquid raw materials, use sampling clean dry sampling pipe/pipette, record maintain during sampling of liquid materials.
      • Dip the sampling Pipette in the liquid container to be sampled and allow it to go up to the bottom of the container slowly. As the sampling pipe goes down, liquid material gets filled up in the pipe. Wait for about 5 – 10 second and close the upper opening of the pipe/pipette with thumb. Draw the pipette out.
      • Let allow the external liquid on pipe/pipette to fall back in container, and collect the sample in sample container as similar procedure as given above for dry materials.
      • Control samples shall be sampled in quantity having twice analysis at the time of sampling, record maintain in “Raw Materials Control Sample” and control sample of raw materials label.
      • Take the sample.
      • After completion of the sampling; tightly close the container and return the container to designated place.
      • Take entry of each sampled batch of raw materials in sampling log book using RLAF & sampled weight log book of analytical balance should be entry and maintain.
      • When one lot of raw materials sampled then RLAF should be cleaned by disinfectant & sampling tools and then next lot of raw materials sampling start on RLAF.
      • The individual sampled bags / bottles for identification test are to be submitted to QC Manager with sample for testing status label along with duly completed Sample advice note and Raw Material Sampling check list.
      • After completion of identification tests on individual samples and compliance, mix the individual samples to prepare a pool / composite sample and label with sample for testing.
      • Analysis the raw materials as per specific data sheets or standard data sheet and maintain the record of raw materials.
      • After complete analysis of raw materials if material is passes in all respect as per respective specification then release the material.
      • Prepare the green colored ‘Approved’ labels and should be pasted on each bags/containers of the whole lot of products.
      • After affix the APPROVED label materials kept in Approved area.
      • If sample is not approved, again take the sample as per standard procedure and analysis.
      • If result again found not complies, then affix the “Rejected” label  and material stored in Rejected area.
• TRAINING:

Trainer   : Manager – Quality Control

Trainees: Staff of the QC departments

• DISTRIBUTION:

Master Copy                  :           QA Department

Controlled Copy            :           QC Department

Display Copy                 :           QC Department

• REFERENCES:

In-House