STANDARD OPERATING PROCEDURE FOR SAMPLING PLAN & SAMPLING PROCEDURE

1.0               OBJECTIVE

To lay down the procedure for the Sampling Plan & Sampling Procedure for Raw Materials (RM), In-Process Material (IP) Finish Products (FP), and Packaging Materials(PM).

2.0               SCOPE

This SOP shall be applicable for the Sampling Plan & Sampling Procedure for Raw Materials (RM), In-Process Materials (IP), Finish Products (FP), and Packaging Materials (PM).

3.0               RESPONSIBILITY

3.1              Microbiologist was responsible for the preparation of this SOP.

3.2              Chemist and above designee shall be responsible for the execution of this SOP.

3.3              Manager QC and Manager QA shall be responsible for checking and approving this SOP.

4.0               ACCOUNTABILITY

Head Quality Control Department

5.0               PROCEDURE

5.1              Sampling procedure for raw material receiving the ‘Material Testing Requisition’ from stores, arrange the sampling Kit which consists of the following items.

              A. SS Scoop / Sampling Thief / Liquid sampler.

              B. Labels (Sampled / Sample for analysis).

  C. Sample bags / Glass bottles.

  D. Mask, Hand gloves.

5.1.2        Go to the respective storage location of the Materials to be sampled and check the following before sampling by using the Sampling Checklist.

A.    Name of the Material on the Label and container

B.     Controlled number, Total Quantity, and No. of containers on Under test Label

C.     Material stored on the Pallet as per the storage conditions

D.    Physical conditions of the containers

E.     Container seal is intact

5.1.3        Take the container carefully to withdraw the samples as per the sampling plan below.

5.1.4        Individual samples from randomly selected containers are taken from homogenous batches. The number of containers to be sampled is given below:-

Sl. No.	No. of containers in Batches	Sampling plan
1	1 to 2	All containers
2	3 to 8	3 containers randomly
3	9 to 15	5 containers randomly
4	16 onwards	Ö n +1

 

5.1.5        If crude material consists of component parts that are 1 cm or less in any dimension, withdraw samples by means of a sampling device from the upper, middle, and lower sections of each container.

5.1.6        Prepare the gross sample by mixing the individual samples from each container and taken as a laboratory sample.

5.1.7        Clean the external surface of the container and follow safety instructions given by the supplier, if any.

5.1.8        Unseal the container and withdraw the required quantity of samples from the individual containers by using an SS scoop for solid materials and a Liquid sampler for liquid materials.

5.1.9        Prepare a Composite sample for chemical analysis and label it with ‘Sample for analysis”.

5.1.10    Prepare the Label ‘Sampled’ with relevant details and affix it to each container sampled. The Label should be affixed on the yellow part of under test Label.

5.1.11    Enter the sample details in the ‘Sample Inward Register’ and keep the sample in the ‘Sample to be analyzed’ tray in Lab.

5.1.12    25-50 gm of the sample shall be collected for analysis.

5.2              Sampling procedure for In-process samples:

5.2.1        Here samples are procured from the production area in the presence of QC persons.

5.2.2        On receiving the ‘Material Testing Requisition’ from the production area, sampling shall be proceeding with the help of a suitable sampling kit.

5.2.3        Samples shall be taken from randomly selected containers of In-process batches. The number of containers to be sampled is given below: -

Sl. No.	No. of containers in Batches	Sampling plan
1	1 to 2	All containers
2	3 to 8	3 containers randomly
3	9 to 15	5 containers randomly
4	16 onwards	Ö n +1

5.3              Sampling procedure for Finished Products:

5.3.1        After receiving the ‘Material Testing Requisition’ from the packing area.

5.3.2        The sampling shall be done for each and every batch which is ready for dispatch.

5.3.3        Two samples shall be collected from packed products randomly using the sampling formula   (√n+1).

5.3.4        One sample shall be kept in the control sample room under controlled environmental conditions and marked with analytical record no. & date.

5.3.5        Another Sample shall be sent for microbial analysis and then transferred to chemical sec. and instrumentation sec.

5.4              Sampling procedure for Packaging Materials:

5.4.1        After receiving the requisition of samples for analysis from the Packaging Stores.

5.4.2        The sampling procedure shall be done according to the table.

Sl.No	No. of bottles, labels, corrugated boxes, etc	Sampling plan
1	1 to 2	All Samples
2	3 to 8	3 Samples randomly.
3	9 to 15	5 Samples randomly.
4	16 onwards	Ö n +1

5.5              Sampling procedure of water:

5.5.1        Refer Sop No ………………….

6.0              REFERENCES

SOP No.	SOP Title
……………………	Microbiology Analysis of Water

7.0              ANNEXURE

Annexure No.	Title of the Annexure	Format No.
Annexure I	Material Testing Requisition	………………………………
Annexure II	RM/IP/FP/PM Inward Register	………………………………
Annexure II	PM Inward Register	………………………………
Annexure II	Microbiology Inward Register	………………………………

8.0              ABBREVIATIONS

SOP                 :           Standard Operating Procedure

QCD               :           Quality Control Department

GEN                :           General

QA                  :           Quality Assurance

Dept                :           Department

No                   :           Number

RM                  :           Raw Material

IP                    :           In the process

FP                    :           Finished Product

PM                  :           Packaging Material

SS                    :           Stainless Steel

TAMC             :           Total Aerobic Microbial Count

TYMC             :           Total Yeast and Mould Count

Lab                  :           Laboratory

 

                                                    END OF DOCUMENTS

My Recent Gadgets purchased after great research:

Boya Microphone: https://amzn.to/3Sd1AhU

American Touristic Bag: https://amzn.to/3k9fXai

Mobile Phone: https://amzn.to/3SaBdJk

Laptop: https://amzn.to/3IvLMDA

Air Drops: https://amzn.to/3EhuOXc

Vega Trimmer: https://amzn.to/3S6BMUx

Camera: EOS 200D-II, (EF-S 18-55 IS STM) https://amzn.to/417hxKw

                                                                                  

Dreaming to update for following

Camera EOS 50 Mark –II EF-M 15-45mm is STM https://amzn.to/417hxKw

Asus Notebook-14 : https://amzn.to/3YGZYzn

You may like to read these links: 

1. List of All SOPs and Documents for the Microbiology Laboratory

2. List of All SOPs and Documents for In-vitro Laboratory

3. List of All SOPs and Documents for the Animal House Facility

4. List of All SOPs and Documents for Clinical Research

5. List of All SOPs and Documents for the Chemistry Laboratory

Enable GingerCannot connect to Ginger Check your internet connection
or reload the browserDisable in this text fieldEditEdit in GingerEdit in Ginger×

SHARE

Owner

Hi. I’m Writer of Researchsop.com. ’ ’ Please share these SOPs to all concern pharma people for their development. I like to fullfill the need of curious people. These things inspire me to make things looks better.

• 
• 
• 
• 
•