SOP for Sampling of Raw Materials in Pharmaceutical Industry | SOP for Cleaning of Sampling Aids |
- SOP for Sampling of Raw Material covers below points :
- Raw Material Sampling procedure
- Operation of sampling rod
- Sampling procedure for Active Raw Material
- Sampling procedure for Inactive Raw Material / Excipients
- Cleaning procedure of Sampling Aids
- Raw material sampling checklist
1.0 OBJECTIVE :
- To describe a procedure for sampling of Raw material and cleaning of sampling aids.
2.0 SCOPE :
- This procedure is applicable to sampling of both active and inactive raw materials (excipients) and cleaning of sampling aids.
3.0 RESPONSIBILITY :
- Quality Control Chemist and above
4.0 ACCOUNTABILITY:
- Quality Control Head
5.0 PROCEDURE :
5.1 Carry out Sampling only by persons who have been trained for this purpose. Use gowns, Masks, gloves and safety goggles while sampling. Sampling aids includes spatula and sampling rod which comes in contact with material.
- Ware house department check for the condition of shipment and actual quantity of Raw material received.
- After receiving the raw material, Warehouse department forward the GRN (Goods Receipt Note) through XYZ system to Quality Control department.
- Make register entry from GRN received.
- After taking the entry in register go for sampling.
- Ensure that Air Handling Unit of the area is working and condition is within the limits.
- Wear the overgown and protective covering like gloves, masks, goggles etc. before entering in the sampling room.
- Take the sampling kit which includes plastic bags, bottles, goggles, gloves, mask, sampling rod, knife, scissors, Under test label, sampled label, spatula, intimation of GRN, white page, format for checklist approved vendor list, cello tape etc. required for sampling.
- Ensure that 100 % “QUARANTINE “label is affixed by Ware house department & ensure that consignment is kept in ‘QUARANTINE “area.
- Before sampling, check the container physically and write down the Raw Material Sampling Checklist.
- Inform to QC head if any discrepancy observed.
- Start the RLAF 15 minutes before sampling to avoid the contamination of the raw material.
- Maintain the RLAF- Pressure Monitoring Record before sampling.
- Transfer the material through pass box to the sampling area from Quarantine area for opening of bag/container.
- Take the Precaution like pressure differential (RLAF), Cleaning, Balance Calibration.
- Open the container in sampling booth.
- Collect samples of raw material using a sampling rod or spatula.
- a) Use Spatula for sampling the material from container which are less than 2.0 Kg.
- b) Use Stainless Steel Sampling rods of desired size for sampling the material from container which are more than 2.0 Kg.
- Maintain the Record in ‘Raw Material Sampling Log Book’ during sampling.
5.2 OPERATION OF SAMPLING ROD:
- Insert the sampling rod into the material and slowly insert the rod into the material downwards till the lower portion of the rod reaches the bottom of container.
- Rotated the inner rod in such away that the material gets trapped in holding chamber.
- Close the window provided in the outer hollow rod by rotating it.
- Collect the sample from top, middle and bottom windows to make the sample as representative sample with the aid of spatula.
5.3 FOR ACTIVE INGREDIENT:
- Insert the sampling rod into the material and slowly insert the rod into the material downwards till the lower portion of the rod reaches the bottom of container.
- Do 100 % Sampling from all of containers of each batch, i.e., each container must be sampled.
- Collect the sample from each container/bag using a sampler in LDPE bag under RLAF.
- Take sample quantity four time to the quantity required for complete Analysis.
- Calculate the sample to be drawn from each container as per following formula,
- Total quantity to be sampled/Total numbers of containers
- (As per approved ‘Sampling Quantity of Raw Material’ sheet)
- Collect the sample in individual LDPE bag for identification and Label each sampling bag showing the container number (approximately 100 mg from each container).
- Draw the sample from each container under RLAF and weigh the composite sample in two different LDPE bags as per ‘Sampling Quantity Of Raw Material’ for control sample and sample for analysis.
- Insert these two bag of composite sample to individual HDPE containers and stick label of ‘RAW MATERIAL’, for chemical analysis on one container and ‘CONTROL SAMPLE’ on other container.
- Ensure containers or bags are properly closed after sampling.
- Prepare ‘UNDER TEST’ labels – on Yellow coloured paper through XYZ System or manually and affix on each container/Bag.
- Affix ‘SAMPLED By’ label on the container and put the date and signature of sampled by chemist to all containers/bags.
5.4 FOR INACTIVE INGREDIENT (EXCIPIENTS):
- Carry out sampling from all containers if containers are less than or equal to four in numbers.
- Use √n+1 formula for sampling, if containers are more than 4 in numbers, where ‘ n’ is number of containers.
- Take sample quantity thrice to the quantity required for complete Analysis.
- Calculate the sample to be drawn from each container as per following formula,
- Total quantity to be sampled/Total numbers of containers
- (As per approved ‘Sampling Quantity of Raw Material’ sheet)
- Collect the samples from containers using a sampler in LDPE bag under RLAF and weigh the composite sample in two different LDPE bags as per ‘Sampling Quantity Of Raw Material’
- Keep this bags in individual HDPE containers and stick label of ‘RAW MATERIAL’ for chemical analysis on one container and ‘CONTROL SAMPLE’ on other container.
- Ensure container or bags are properly closed after sampling.
- Prepare ‘UNDER TEST’ labels – on Yellow coloured paper throughXZY System or manually and affix on each containers/Bags.
- Affix ‘SAMPLED By’ label on the container and put the date and signature of sampled by chemist to all container/bags from which sampling is done.
5.5 CLEANING OF SAMPLING AIDS :
- After sampling, cover the sampling aid with plastic bag and transfer to washing area of warehouse department.
- Clean the adhering powder with clean cotton and discard the cotton in waste basket.
- Wash the aids with 0.1% teepol solution and then wash thoroughly in running water to make free from any adhering mass and teepol solution, and finally rinse with Purified water.
- Wipe and dry with clean lint free cloth and keep in a plastic bag to protect from dust.
- Affix a ‘CLEANED’ status label on the plastic bag containing details like name of person who has done the cleaning and date of cleaning.
- Maintain the record for Cleaning Of Sampling Equipment.
5.6 STORAGE OF SAMPLES BEFORE ANALYSIS:
- Store the sample in dedicated place as per specified storage condition in Quality Control department up to analysis.
- Complete the analysis within six days.
6.0 ABBREVIATIONS:
| Abbreviation | Expanded form |
| GRN | Goods Receipt Note |
| RLAF | Reverse Laminar Air Flow |
| LDPE | Low Density Polyethylene |
| HDPE | High Density Polyethylene |
| Kg | Kilo gram |
7.0 ANNEXURES
| Annex. No. | Title |
| 01 | Format For Sampled by Label |
| 02 | Format For Under Test Label |
| 03 | Format For Raw Material Sampling Checklist |
| 04 | Format For Sampling Quantity Of Raw Material |
| 05 | Label For Raw Material HDPE Container |
| 06 | Format For Raw Material Sampling Log Book |
| 07 | Format For RLAF- Pressure Monitoring Record |
| 08 | Format For Cleaning Of Sampling Equipment |
8.0 SOP REFERENCES
- GMP guideline
END OF THE SOP
ANNEXURES :
Annex. No. 01 Format For Sampled by Label
Annex. No. 02 Format For Under Test Label
Annex. No. 03 Format For Raw Material Sampling Checklist
Annex. No. 04 Format For Sampling Quantity Of Raw Material
Annex. No. 05 Label For Raw Material HDPE Container
Annex. No. 06 Format For Raw Material Sampling Log Book
Annex. No. 07 Format For RLAF- Pressure Monitoring Record
Annex. No. 08 Format For Cleaning Of Sampling Equipment
