| Reclassification, Quarantine, Intimation To Qc, Sampling And Approval / Rejection Of Raw Material |
1.0 OBJECTIVE: 1.1 To lay down the procedure for the reclassification, quarantine, intimation to QC, sampling and approval / rejection of raw material. 2.0 SCOPE: 2.1 This procedure is applicable for the reclassification, quarantine, intimation to QC, sampling and approval / rejection of raw material in Warehouse. 3.0 RESPONSIBILITY: 3.1 Assistant -Warehouse shall be responsible for the segregation of reclassified quantity, quarantine and intimation to QC of raw material as per their condition and status. 3.2 QC chemist is responsible for the sampling of the material and clears the status of Sampling And Approval or Rejection in coordination with Head QC. 3.3 Warehouse In-charge shall be responsible for implementation of the procedure as per the SOP. 4.0 ABBREVIATIONS 4.1 SOP : Standard Operating Procedure 4.2 QC : Quality Control 4.3 QA : Quality Assurance 4.4 GRN : Goods Receipt Note. 4.5 API : Active Pharmaceutical Ingredients 4.6 CC NO : Change Control Number 5.0 PROCEDURE: 5.1 Reclassification of the Material: 5.1.1 Officer warehouse will take the approval for reclassification of material (code to code transfer) from the concerned party. 5.1.2 After approval of reclassification, Warehouse personnel will collect the document from store in charge and check the following details of the materials. 5.1.2.1 Check the correctness of material code and name of material which is to be segregated. 5.1.2.2 Check the availability of Certificate of Analysis copy of the material. 5.1.2.3 Ensure the description of the material as per reclassification document. 5.2 Segregation Activities: 5.2.1 Warehouse personnel check the material container for external identification label and verify the material name and material code is as per the reclassification document. 5.2.1.1 Check any storage conditions are mentioned on the container label. 5.2.2 Check the supplier’s / Manufacturer’s approved label available on the container / pack. 5.2.3 Ensure the physical verification of the material to be reclassified. 5.2.4 Clean the external surface of the container by using dry cloth/ lint free duster. 5.2.5 After cleaning, paste the status label on the reclassified material and deface the previous label. Label shall be generated through the ERP. 5.2.6 The step 5.2.5 is applicable for the intact containers only. 5.2.7 If the material separated in the loose quantity, it shall be segregated in the dispensing area as per the property of material like active & inactive. 5.2.8 Before weighing the material ensure that the weighing balance has been calibrated. 5.2.9 Transfer the container by using trolley and other suitable means to the dispensing area. 5.2.10 Switch ON the balance wait till zero comes. 5.2.11 Weigh and segregate the desired qty as per reclassification document. 5.2.12 Affix the ERP generated label as per step no. 5.2.5. 5.2.13 Record the gross, net and tare weight in the label of the container. 5.2.14 Update the quantity of the material used for classification. 5.2.15 After completion of weighing switch OFF the balance and ensure the cleaning of balance. To read this SOP click here SOP for Receipt and Storage Approval / Rejection Of Packing Material. 5.3 Quarantine Procedure: 5.3.1 Ensure the cleanliness of the storage racks. 5.3.2 Transfer the material to Quarantine area and store the material as per recommended storage conditions. 5.3.3 Stack the materials in designated storage area/racks. 5.3.4 Record the Material in Material Reclassified Register as per XXX. 5.3.5 After selecting the required series of material reclassification, Prepare Goods Receipt Note. – Raw material (Computer slip) of the material. 5.3.6 Make three copy of Goods Receipt Note (GRN) which is created by Computer software and send all the copy to Quality Control department and get acknowledgement in GRN control register from QC as per XXX. 5.3.7 Co-ordinate with Quality Control Chemist for material sampling. 5.3.8 Ensure the Quality Control chemist affix of label “SAMPLED/UNDERTEST”, on the container which is sampled. 5.3.9 Ensure the sampled containers are sealed properly and repacked back. 5.4 Approval / Rejection: 5.4.1 After analysis, Quality Control sends back the Goods Receipt Note to warehouse indicating the material status and mention the Quality Control sampled qty, (Approved or Rejected) along with the Certificate of Analysis (In case of active material). 5.4.2 Ensure that Quality control chemist Affixes “APPROVED”/ “REJECTED” (Computer slip label) on all the containers / packs. 5.4.3 In case of rejection, shift the material to the Rejected Material Store area having lock and key facility, just after the receipt of the material affixing the REJECTED labels on the container. Inform to Purchase department for return to vendor along with proper documents and update the list of rejected material as per Annexure –VIII of SOP No. XXX. 5.4.4 Ensure all the status labels are filled properly with date and signatures. 5.4.5 Transfer the material to designate approved area and store under recommended storage conditions. 5.4.6 Enter the Re-testing date into the software. 5.4.7 File the GRN as per order in the file. |
