STANDARD OPERATING PROCEDURE SAMPLING OF RAW MATERIAL

STANDARD OPERATING PROCEDURE

SUBJECT:                      SAMPLING OF RAW MATERIAL

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : Version No                  :

1.0       OBJECTIVE:

To provide guidelines for sampling of Raw materials.

2.0       SCOPE:

It is for analysis to check the quality and purity of raw materials.

2.1       DEFINITION OF THE TECHNICAL WORDS:

2.2       LOT    

           

All the containers in a single consignment of the material drawn from the single batch of manufacture shall constitute a lot. The samples will be drawn from each lot separately as per the sampling formula.

2.3       SAMPLING

The random sampling plan is followed taking care that the sampling is done in a       fixed sequence from every layer/ side. The testing is undertaken on the composite sample representing the entire lot. Identification test or any critical test is done on individual container sample. Sample will be collected in duplicate, one for testing and other for control or retain sample.

3.0       PROCEDURE:

3.1.      Warehouse will prepare GI note on the receipt of materials and send the same to QA in

attached format General inward inspection report Annexure-1 Sop No.05/QA.

3.2       QA Executive will enter the details of the GI Note in the Raw materials QC Register and Inspection Report of Raw Material along with the other observations noticed in the format included in annexure-2 Sop No.06/QA.

3.3.      Check the shipment condition and cleanliness of packets/cases received.

3.4.      Check for correct identification of packets/ cases and component tags fixed by warehouse.

PREPARED BY                            REVIEWED BY                                        APPROVED BY

           

SOP No.       :  

Page             :

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3.5       Inspect the received consignment thoroughly and check for any defects in the supply.

3.6       SAMPLING FORMULA

                                                                 

All the additives will be sampled as per \/N + 1(square root of N plus one) where N is number of containers received. In case of active ingredients 100% containers are sampled.            

3.7       RAW MATERIAL SAMPLING:

While sampling wear masks, gloves, head gear and goggles if required. After sampling is completed ensure that the polybags are tightly closed, and lids are properly placed on containers. Before drawing the samples QA staff should check the following details and will fill the Inspection Reports of,

            

Raw Material,

            Name of the material,

            Batch number,

            Name of the manufacturer,

            MRN/GIN no.

            Quantity,

            Physical condition of container.

The above details are to be record in format provided in “Inspection Report of Raw Materials”Annexure-1 Sop No. 05/QA.

If any container is damaged sample the container and record the details in inspection report.

                                                                                                                                   

3. 8      METHOD OF SAMPLING:

Before drawing the sample the sampler is cleaned and sanitized. (70% IPA can be used for sanitization). The containers should be cleaned outside   before drawing the sample. All the containers after drawing the sample should be closed properly and should be labeled as “SAMPLED”.

3.8.1    Before sampling switch on the AHU of the sampling booth and also the LAF sampling booth.

3.8.2    Let the LAF & AHU run for 10 min.

3.8.3    Switch on the balance and calibrate the balance and record the observations in the annexure –              

             20, SOP No: 03/W (DS-852 G, Essae balance)

3.8.4    Line up the raw material to be sampled in the sampling booth.

PREPARED BY                            REVIEWED BY                                        APPROVED

           

3.8.5    Ensure that all clean sampling tools are available for sampling.

3.8.6    The materials to be sampled are taken into the booth from the material entry door.

3.8.7    The personnel are to enter the booth from men entry door.

3.8.8    After entering the booth the chemist need to remove the apron & wear the apron kept in booth.

3.8.9    The chemist need to wear mask, gloves, head gear & goggles if required.

3.8.10  The chemists need to cross over and enter into the sampling booth.

3.8.11  FOR SOLIDS:

A sampler, having a pointed end is used. (The sampler suitable for drawing samples from different levels). Sample should be drawn from the full length of container by a stage wise sampler.

3.8.12  FOR LIQUIDS:

Before drawing the sample the drum should be rolled on ground for 10 to 15 times. The sample is drawn using dried clean siphon.

3.8.13   FOR BULK:

For PHCL sampling is done from Bulk samples received from France. Only those containers which are in opened condition i.e without seal are sampled for at Elegant. The seal are not opened at for sampling as the product will get contaminated in  case all  the containers are sealed then the sealed containers  are open random to draw samples. Sampling of bulks is done in the adjacent manufacturing area which is controlled area which Air handling unit. The sampled material is brought to the QA laboratory for testing. A counter sample is kept as retention sample purpose. The sample is analyzed as per the specifications.      

3.8.14  Acceptance or Rejection:

The consignment is accepted if it passes the tests laid down in the specification. If the

consignment fails in the tests specified it will be rejected.

3.8.15 STORAGE AND HANDLING OF SAMPLES:

PREPARED BY                            REVIEWED BY                                        APPROVED BY

           

3.9.1    After sampling, the following details are written on the QC samples:

            Name of the material:

            GI No:

            Batch no.:

            Dt. of Mfg.:

            Qty. / No. Of containers received:

            Dt. of sampling:

            Sampled by:

            Name of the manufacturer:

Samples to be analyzed and tested samples are kept in separate racks & labeled accordingly. Tested samples are destroyed as per SOP no. 19/ QA and retention samples are stored in the control samples room with proper labels as per SOP no. 13/ QA.

            After sampling the sampled and under test are pasted on the container. The sampling of the

             consignment is crosschecked by a senior who initials on the sampled container and on the

             inspection report. (This is for DRL consignments only)

3.9.2    After sampling is completed all tools used for sampling need to be cleaned and sanitized. Sanitized sampling tools need to be stored separately and duly labeled.

3.9.3        After sampling is completed the log book of the sampling booth need to be updated and the chemist need to deposit the sampling booth apron in the sampling booth & exit from the booth.

3.9.4        The sampling booth is to be cleaned and entered in the log book.

3.9.5        After cleaning the AHU sampling booth LAF & lights need to be switched off and the doors of the booth need to be closed.

3.9.6        The preventive maintenance need to be carried out and recorded as per the annexure – 24a, 24b, 24c SOP No:02/ENG

4.0       FREQUENCY: As and when required.

5.0       RESPONSIBILITY: Executive Q.A.

6.0       REVIEW GUIDE:   Log book.

7.0       ANEXXURE:

                                       1. General inward format.

                                   2. Inspection Report of Raw Material              

PREPARED BY                            REVIEWED BY                                        APPROVED BY

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	x
Warehouse	x	√
General	x	x
Maintenance	x	√