SOP on Procedure for sampling of raw material

Raw material

SOP on Procedure for a sampling of raw material


To lay down the procedure for sampling raw material.


This procedure is applicable for a sampling of raw material in a Pharmaceutical company name with location.


QC personnel shall be responsible for following the procedure mentioned in this SOP.


QC and QA Head shall be accountable for the implementation of this SOP.


A.R. No.: Analytical Report No.

GRN: Goods Receipt Note

LDPE: Low density polyethylene

IPA: Isopropyl Alcohol

cGLP: Current Good Laboratory Practice 


A sampling of Raw Materials:

Raw material sampling shall be initiated after receiving the “GRN” from the warehouse.

QC personnel shall enter the material details in the raw material control register and allot A.R.No.

QC personnel shall generate labels of “SAMPLED”.

QC personnel shall generate labels of “UNDER TEST”. The no. of ‘UNDER TEST’ labels shall be ‘no. of container(s) + 1’.

If number of containers is five then six under-test labels shall be taken out and one label will be numbered 00 of 05, 00 of 05 for specimen label with sampling report, and 01 of 05 for container numbers 01, 02 of 05 for container number 02, and so on.

QC personnel shall go to the warehouse along with ‘Sampling Report of Raw Material’, GRN, Sampled labels, and Under Test labels.

QC personnel shall check the material as per GRN.

QC personnel shall have to ensure that “Quarantine” labels are affixed on each unit pack by the warehouse department.

QC personnel shall enter into the sampling booth as per SOP and Check the status label “CLEANED AREA” on the sampling booth before entering the sampling booth.

Ensure that the Differential pressure of the sampling booth is within the limits and record the observations.

Ensure that the temperature and Relative Humidity of the sampling booth are within the limits and record the observations.

The Manometer of the Reverse Laminar Air Flow is to be checked before starting the airflow. The manometer level should be at the “zero” position. The RLAF shall be kept on at least 15 min before the start of sampling. Operate the RLAF as per SOP.

Record the sampling start time and differential Pressure of the RLAF in the sampling operational log book.

A sampling of non-sterile solids shall be carried out under RLAF located in the sampling area of the warehouse. A sampling of liquid materials shall be done in the area dedicated to liquid sampling.

A sampling of sterile materials shall be done as per SOP.

QC person shall use cleaned and dried Sampling devices. These sampling devices shall be wrapped in aluminum foil with the status label “Cleaned and Ready for Use”.

QC personnel shall use sampling utensils as follows:

Type of Raw materialUtensils – Sample collection container

  • For liquid sampling from drum/bag/container – S.S. sampling rod – Glass bottles.
  • For liquid sampling from bottles – S.S. sampling rod – Glass bottles.
  • For a sampling of material from solid bulk containers –  SS sampling rod / SS spatula –  LDPE bag

QC personnel shall open the containers or bags under the sampling booth individually and take out the sample as per the sampling plan given above.

Sampling Plan:

Before taking the container(s) inside, ensure that the container(s) are clean. If any container is found damaged or with a broken / tampered seal then the container shall be rejected and the same shall be informed to the In-charge of the Warehouse department.

Observe visually the appearance of the material for any abnormalities like discoloration, lumps, non-characteristic odor, foreign matter, physical heterogeneity, etc.

Material of only one batch number shall be sampled at a time. After sampling of each material cleaning shall be done as per SOP.

Withdraw the sample from the no. of containers as per the table given below:

Type of Material – Inactive

 No. of Containers – √n + 1 of the total container

Type of sample –

1. Composite Quantity (for analysis & for retention sample)

2. From each sampled container (for identification)

Type of Material –  Active

 No. of Containers – 100 % of total containers

Type of sample –

1. Composite Quantity (for analysis & for retention sample)

2. From each container (for identification).

If no. of containers of inactive materials is five or fewer five then each individual container shall be sampled.

The container number of each container shall be assigned as x/y where x is the serial number of the container and y is the total number of containers, e.g. 1/10 shall be assigned for the first container out of 10 containers.

Put the container number on a label affixed on the sample for identification. Label of ‘SAMPLE FOR IDENTIFICATION’.

QC personnel shall open the containers or bags under the sampling booth and withdraw quantities as per the list prepared for active materials and inactive materials.

A list of sample quantities of active and inactive raw material shall be prepared and reviewed by the QC department and approved by the QA department. The quantity to be sampled shall be as per the approved list. The list shall be revised, if the sample quantity of any material has to change or new material has to be added to the list.

The sample shall be collected from the top, middle & bottom of the layers from the drums for solid materials and for liquid/solvent, the top and bottom portions of the barrel/containers. In case of any abnormalities are observed, inform to QA Officer for necessary action.

Mix the top, middle, and bottom portions of solid raw material in the S.S. sampling pan and transfer the required material for identification in LDPE (Low-density polyethylene) polybag.

In raw materials where microbiological testing is required, the sample is to be drawn in a separate glass vial bearing the label “SAMPLE FOR MICROBIAL ANALYSIS” from every sampled container. Label of Sample for Microbial Analysis.

The glass vial and spatula for the micro-sample should be sterile.

Raw materials of specific nature, are to be sampled with care, (where their potency, characters, and stability are related to storage conditions, i.e. specific temperature, humidity, light-resistant or any such requirements).

For composite samples, withdraw the appropriate quantity of sample equivalent to the required quantity from individual containers ensuring that approximately equal quantities are drawn from individual containers.

Fill in the required quantity from the composite sample for “RETENTION SAMPLE” as well as for “SAMPLE FOR ANALYSIS”.


Properly close the container(s) under RLAF and affix a self-adhesive label of “SAMPLED”.

Affix a self-adhesive label of “UNDER TEST” on all containers of that batch.

Record all observations in the sampling report of raw.

Cleaning of Sampling Devices:

Sampling devices shall be washed with running purified water.

During the washing of the sampling devices, if any residue is visually seen, scrub the sampling devices with a lint-free cloth and wash them thoroughly with purified water.

After removal of all residues from the sampling devices, rinse the sampling devices thoroughly with purified water and finally rinse the sampling devices with Isopropyl alcohol and dry it.

After completion of drying, wrap the sampling devices in aluminum foil and put the “CLEANED & READY FOR USE” status label.

Keep the sampling devices in a designated place.

Record the cleaning activity in the cleaning and usage log for sampling devices.

Bring the sampled polybags/ Glass Bottles to Quality Control Laboratory for analysis.

List of Annexures / Formats:

Raw material Control Register – Annexure I

Sampling operational log book – Annexure II

Cleaning and usage log book for sampling devices – Annexure III


Master copy – Quality Assurance

Controlled copies – Quality Assurance, Production, Quality Control, warehouse


Annexure I

Raw material Control Register

  • Name of Material Manufacturer/
  • Supplier name
  • GRN No/Date
  • Mfg. Date
  • Exp./Retest Date
  • Quantity Received
  • No. of Containers
  • A.R.No.
  • Sampled By/
  • Quantity
  • Analyzed By/Date

Annexure II

Sampling operational log book

  1. Date of Sampling
  2. Name of Material
  3. A.R. No.
  4. RLAF Started at
  5. Sampling Time – Start Time & End Time
  6. Magnehelic Reading after 15 mins
  • Pre-Filter – 1 mm-5 mm
  • Fine-Filter – 5 mm-10 mm
  • Hepa-Filter – 10 mm-20 mm

Annexure III

Cleaning and usage log book for sampling devices

  • Sr. No.
  • Date
  • Sampling devices
  • ID No.
  • Used for Material
  • A.R. No.
  • Cleaning Time (Started at and Completed at )
  • Done By
  • Checked By

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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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