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Sampling of Different Materials in Pharma SOPs 1

To describe the procedure for sampling of different materials in pharma as per quality control requirements. In this blogpost we will study how to sampling of Raw Material, Packing Material etc.

Sampling of Different Materials in Pharma

Scope: This procedure is to be used as basic guideline for different sampling procedures to ensure the safe and representative sampling of the materials required by quality control for different purposes.

Responsibility: QA Officer/ Senior QA Officer

Procedure:

Raw Materials

General

Receive the Raw material Goods Receiving Note (GRN) from Raw Material Warehouse (RMWH) upon arrival of raw materials. Eateries are made in inventory system through by the store pharmacist. Then after receiving the Certificate of Analysis and other necessary document i.e. Form3 and from7, QA person made entries in the inventory system and get the prints of sampling plan and the bar code stickers for under test regarding chemical and microbial testing.

Sample each container of each lot individually if shipment consists of material manufactured in several lots. It is necessary to give the separate GRN number to each lot in a consignment of the same material.
Pockets (on shirts or uniforms/overalls) should always be empty to avoid the accidental falling of pocket materials into the container being sampled.

The lot must always be examined before sampling for damaged fibrite/containers, name, batch number, code number and quantity while you are Sampling of Raw Material.

Precautions shall be taken to draw the samples in a manner so as to protect the samples, the material being sampled, the sampling equipment and the containers for sampling from cross contamination.

Materials must not be poured back into the bulk containers.

For volatile liquids, samples should not be filled to more than 70% of the capacity of the containers, to allow for expansion.

Procedure

1. Sampling plan and the bar code stickers will be obtained after making enteries in the inventory system.
2. Collect necessary sampling tools which are previously washed with distilled water and then dried and stored in a clean container to avoid any contamination. Wrap the sampling tool in aluminium foil.

3. Take out sample in a suitable clean and dry container properly sealed and identified by labeling with complete name of item, GRN # , lot # , sample # (S1, S2, S3,………….etc), date of sampling and initials of sampler.

4. Take the samples of the whole lot one by one from all the containers.
5. Mix the liquid materials thoroughly before sampling and then take sample.
6. For powders in bags torn two ends of small rectangular part with scissor. With the help of a catcher fold back the cut end and take the samples with the help of spatula or scoop. After sampling seal the torn place securely with proper tape etc.

Microbiology Sampling

• Samples that require microbiological testing are also sampled by
QA officer.

• Samples are taken in sterile polythene ‘Whirl Pack’ bags or container properly covered and sterilized. The spatulas or scoops are also sterilized contained in SS box or individually wrapped in aluminum foil.

• Wear mask and then sterile pair of gloves and mop with IPA solution (70 % v/v) to disinfect the gloves. Also mop or spray the surface from where the sample is to be taken. Let it be dried before sampling.

• Sample the material taking all necessary precautions and close/ cover the bag/ container immediately after sampling.

8. Paste securely the ‘Under Test’ sticker bearing Material name, GRN #, lot #, Sample #, date sampled and signature of sampler on each container/bag from which the sample has been taken.

9. Take the duplicate copy of TN from RMWH representative and keep the record.
10. Transfer the samples to Quality Control lab. for further processing.
2. Finished Pack
In-process products, filled & finished packs are sampled by QA In-process Officer as per instructions or procedures.

The fibrite of finished, packed products must always be securely resealed after making up for the sample withdrawn. Make sure that there is only one loose fibrite in the batch.
Sterile Products
Collect the samples in a clean dried polybag/ container.

Sterile containers are sampled randomly preferably from each filled container. The sample must include the start and end time containers and when there are some unusual conditions of filling as mentioned below:

a. Breakdown of electricity.
b. Temporary breakdown of machine.
c. Filter has to be replaced during filling.
d. Any drop of air pressure during filling.
e. Some kind of repair work during filling.
f. Any other kind of adverse conditions or mishandlings.
I. Ampoules
For Reference For Chemical Test For Microbiological Test
2 Packs/batch 1 Pack/batch 50 Ampoules/batch

II. Intravenous Infusions
For Reference For Chemical Test For Microbiological Test
6Bottle/batch 2 Bottles / batch 22 Bottles / batch

In-Process Samplings

The Quality Assurance representative will receive the “Request for Analysis” from the concerned production officer. He/she, after consulting Assistant QC Manager will give the approximate time of sampling and report of analysis on the same request. One copy is retained in QC for record.

The Assistant Quality Control Manager schedules the Quality Assurance In-process Officer to collect the sample from the concerned section of the Production Department in Sampling of Different Materials in Pharma.

The concerned Quality Assurance In-process Officer checks the container that it has been placed properly and a identification slip is pasted on each of the container and also makes sure that all information provided in the Request for Analysis are correct.
The QA Officer takes the sample with stainless steel scoop/ spatula or pipette in polyethylene bags or glass containers whichever is best suited.
In case of sterile product microbiologist is responsible for sampling.

Sampling of Different Materials in Pharma quantity of the sample varies from product to product for the purpose of analysis.

Mixing

On Receiving “Request for sample” Sample will be taken from the Mixer, where the whole batch should be present. The amount of sample should be Sufficient for 3 tests or as per Q.C requirement in Sampling of Different Materials in Pharma

Sampling of Different Materials in Pharma

Encapsulation:

During the regular monitoring of encapsulation, Q.A Officer collects the sample of filled capsules (15-20 capsules) or sufficient for testing on hourly in-process check at encapsulation and submits that collective sample to Q.C in Sampling of Different Materials in Pharma

Powder for Suspension/Sachet

On receiving “Request for Analysis” Sample will be taken after recirculation of bulk powder during mixing stage from the out let of compounding vessel and total volume of bulk powder should be checked before sampling in Sampling of Different Materials in Pharma.

Vials

After receiving Request for Analysis from sterile department, samples at filled vials stage will be collected after terminal sterilization (quantity of sampling according to batch size) and then should be submitted to Q.C in Sampling of Different Materials in Pharma.

Ampoules

At the end of autoclave, take sample of ampoules from each and every tray and (quantity depending upon batch size) submit the collective sample to Q.C in Sampling of Different Materials in Pharma.
After collecting the sample the concerned Quality Assurance Officer paste the containers with “Under Test” slips.
Transfer the sample to QC securely for further processes.

Packaging Materials

Draw samples of packaging materials for testing according to the following procedure.

Cartons

Draw samples for each opened fibrite as under:

Samples Size = No. of units in a fibrite
No. of fibrites opened
Sampled and tested cartons are returned back to stores for use.

Labels

Open √n + 1 fibrite (where “n” is the number of fibrites).
Draw samples for each opened fibrite as under:

Samples Size = No. of units in a fibrite
No. of fibrites opened
Check the winding direction of the rolls. Sampled and tested cartons are returned back to stores for use.

Leaflets

Take a total number of about 30 leaflets. A few leaflets should be taken form several bundles. Sampled and tested leaflets are returned back to stores for use.

Measurers/ Spoons

Open √n + 1 fibrite (where “n” is the number of fibrites).
Draw 10 random samples form each bag.
Destroy the samples after testing.

Fibrites & Tins

Check general appearance and condition of material in the stores. Open √ n + 1 bundles (where “n” is the number of bundles).
Collect one sample from each bundle.

Gum Tape Rolls

Collect 3 samples, one form each fibrite.

Aluminum Foil Reels

Check general condition and appearance of material. Check that the edges of rolls are not damaged and the rolls are properly wound.
Sample √ n + 1 Aluminium foil rolls (where “n” is the number of bundles).

Important Points

1. Appropriate safety precautions must be taken (consult the Hazard Data Sheets).
2. Always consult the QC manger before sampling a new material or product while Sampling of Different Materials in Pharma.
3. The batch must always be examined before sampling for damaged fibrite/containers, name, batch number, code number and quantity etc.
4. Any spillage must be dealt immediately (consult the SOP on spillage).
5. In case of finished, packed products the fibrite must always be securely resealed after making up for the sample withdrawn. Make sure that there is only one loose fibrite in the batch.
6. A carrier must always be used to transport samples.
7. The sample containers should be sealed air tight after sampling and marked with full details as batch number, name of the materials, code number, and date of manufacture, name of the manufacturer/supplier or any other information regarding assay or potency appearing on the container form where the sample is drawn.
8. Samples should be stored in such a manner that the storage conditions do not adversely affect the quality of the material.
9. Sufficient sample of each lot of material should be retained under ambient conditions (unless otherwise advised) for a period of three years.
10. If a container is found damaged, it must be kept separate form the rest of the containers.
11. Collect sample from each defective container. Samples from sound containers should be collected separately.
12. If a material consists of several batches, the batches are segregated and a sample is collected separately from each batch or lot received.
13. The batch must always be examined before sampling for damaged fibrite/containers, name, batch number, code number and quantity.
14. Any spillage must be dealt with immediately (consult the SOP on spillage).
15. In case of finished, packed products the fibrite must always be securely resealed after making up for the sample withdrawn. Make sure that there is only one loose fibrite in the batch.
16. A carrier must always be used to transport samples.
17. The sample containers should be sealed air tight after sampling and marked with full details or batch number, name of the materials, code number, date of manufacture, name of the manufacturer/supplier or any other information regarding assay or potency appearing on the container form where the sample is drawn.
18. Samples should be stored in such a manner that the storage conditions do not adversely affect the quality of the material.
19. Sufficient sample of each lot of material should be retained under ambient conditions (unless otherwise advised) for a period of three years.
20. If a container is found damaged, it must be kept separate form the rest of the containers.
21. Collect sample from each defective container. Samples from sound containers should be collected separately.
22. If a material consists of several batches/lots, the batch lots are segregated and a sample is collected separately from each batch or lot received.

Safety Precautions

1. Follow the special sampling requirements and safety precautions where required.
2. Ensure that safe working place with adequate light and ventilation is available at the time of sampling.
3. Use goggles, face mask or visors for eyes and face protection when necessary.
4. Use gloves as hand protection for sampling irritant or corrosive materials.
5. Wear rubber shoes for foot protection.
6. Use Laboratory coats for inner clothing’s and body protection.
7. While sampling pungent liquids, use special respiratory protection equipments.

8. Sampling of Different Materials in Pharma is for maintaining Quality of Good

 

Pharma is for maintaining Quality of Good Positive Effects:

  • One of the most Positive effect of Sampling of Different Materials in Pharma is that every material Quality is maintained

Pharma is for maintaining Quality of Good Negative Effects:

  • There is some wastage of higly cost materal

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