The choice of a SOP for Sampling and Testing of Raw Materials plan should always take into consideration the specific objectives of the sampling and the risks and consequences associated with inherent decision errors. The bibliography at the end of this Annex should be consulted when justifying a sampling plan for a given purpose.

All SOP for Sampling and Testing of Raw Materials operations related to sampling should be performed with care, using proper equipment and tools. Any contamination of the sample by dust or other foreign material is liable to jeopardize the validity of the subsequent analyses.

Purpose:-

It is established to provide the guidelines for the SOP for Sampling and Testing of Raw Materials of sterile & non sterile Raw Materials so as to get the representative sample of the whole lot for analysis.

Scope:-

This procedure covers the sampling and testing of raw materials and this is applicable to Quality Control Department.

HSE Statement:-

Below mentioned PPE are required for the implementation of this SOP:-

• Safety Mask
• Safety Gloves
• Safety Goggles

Responsibilities:-

• Officer QC (Raw Material)
• Quality Control Manager
• Microbiologist
• Sr. Officer QC

Material

• N.A

Definitions:-

Raw Material SOP for Sampling and Testing of Raw Materials:

The basic material from which a product is made. OR A material or substance used in the primary production or manufacturing of a good.

Sampling:

It is a part of a large bulk/product which represents the whole bulk/product and the characteristics possessed by this part are the same as that of the bulk/product.

Flow Chart:

1. Raw material receiving and GRN preparation by Material management Officer
2. Officer QC Receive the GRN enter the information in raw material receiving register and generate the QC number
3. After necessary preparation Officer QC go for sampling verifies the information on the container and conduct sampling as per plan
4. Test the Material against approved specifications and affix the status label after MQC approval

After receiving the raw material, material management officer prepares Goods Receiving Note and send to Quality Control Department along with COA. QC officer receives the GRN, enters its information in the Raw Material Log Book and assigns it a QC number. Then he labels the containers / zipper bags in which samples to be taken as per sampling requirements. Physically damaged packs/ containers shall not be considered for sampling and the same shall be rejected. Before starting sampling ensure that the sampling area is cleared of all previous raw materials and should be neat and clean. After cleaning externally and verify that batch number, manufacturing date & expiry date is as per COA.

Sampling of all containers will be conducted in case of active pharmaceutical ingredient.

Solid ( for composite sample)	~ 1 gm for each container
Solid ( for Identification)	~ 1-2 gm for each container
Liquids ( for composite sample)	~ 5ml for each container
Liquids ( for Identifications)	~ 10ml for each container

Description:-

Sampling:

1. After receiving the raw material, material management officer prepares Goods Receiving Note and send to Quality Control Department along with COA.
2. QC officer receives the GRN, enters its information in the Raw Material Log Book and assigns it a QC number.
3. After that he prepares the sampling labels as per number of containers to be sampled.
4. Then he labels the containers / zipper bags in which samples to be taken as per sampling requirements.
5. He verifies the material against the details provided in the COA & GRN.
6. Physically damaged packs/ containers shall be assessed by the officer material management and officer quality control in order to verify intactness of inner most packaging. Sampling shall be done specifically from the intact containers.
7. Physically damaged packs/ containers shall not be considered for sampling and the same shall be rejected.
8. Before starting sampling ensure that the sampling area is cleared of all previous raw materials and should be neat and clean. Bring the containers / packs inside the sampling booth after cleaning externally and verify that batch number, manufacturing date & expiry date is as per COA.
9. Observe visually the appearance of the material for any abnormality like discoloration, lumps, non characteristic odor foreign matter and physical heterogeneity.
10. In case of any abnormality reject the entire consignment with out sampling.
11. Keeping in account the sensitivity of the material towards light and moisture the Quality Control Officer takes sample with care using stainless steel spatula/scoop or pipette & collects sample in Zipper bag(in case of solid) or glass beaker/plastic container (in case of liquid).
12. Withdraw approximately equal quantities from all containers / packs for preparing pooled sample (composite sample) by using clean spoon / sampling rod / pipette.
13. Sampling of all containers will be conducted in case of active pharmaceutical ingredient. Quantities to be

sampled from each container and for pooled sample are listed below:

Solids(for composite sample)	= ~1gm from each container
Solids(for Identification )	= ~1-2gm from each container
Liquids(for composite sample)	= ~ 5ml from each container
Liquids(for Identification)	= ~ 10ml from each container

1. Sampling of the bulk Sterile Material should be handled with care to maintain the sterility of the product. Sampling of such materials is done under LFH in sterile area and in a sterilized sampling container.
2. The sampling of inactive raw materials is carried out according to American Military Standard MIL-STD 105D.
3. Standard sample quantity for inactive raw materials for each sampling container is as follow.

Solids(for composite sample)	= ~1gm from each container
Solids(for Identification )	= ~1-2gm from each container
Liquids(for composite sample)	= ~ 5ml from each container
Liquids(for Identification)	= ~ 10ml from each container

NOTE: If the number of containers to be sampled is greater than 10 then sampling quantity for composite sampling may be reduced. Take sample quantity which is sufficient for minimum of three analysis.

Respiratory mask, overall and disposable gloves are to be worn for all chemical raw materials sampling, always wash off any spillage of material on your skin immediately.

After collecting sample QC officer affixes the “Sampled” label on container(s) which are sampled.

Testing of Raw Materials

1. After sampling QC officer will conduct the testing of raw materials.
2. Identification test of each sampled container is carried out separately.
3. Assay is carried out on composite sample.
4. If on testing of identification of raw material in case of inactive, any of the container / pack found non-conforming to the specifications then all the containers will be sampled for identification test to make final decision.
5. If more than three percent of containers / packs does not comply the identification test in case of non active materials then whole lot will be considered as rejected.
6. In case of active ingredient all the containers should pass the identification test.
7. After analysis Quality Control Officer will prepare the analytical report and it will be checked by the Quality Control Manager.
8. Quality Control Manager decides according to results about Release or Rejection of the raw Material.
9. After the decision of the QC Manager, Quality Control Officer affixes the label on the respective container to declare its status.
10. If retest date is provided by the supplier then Officer QC put this retest date on the column available in the release label, if supplier mention only the expiry date then Officer QC will put 1 month prior retest date to the expiry date in the column.

Record:-

• Raw Material Receiving Record
• Certificate of Analysis Raw Material

References:-

• In-house/International Guidelines