Month: September 2021

Procedure for Dispensing of solvent and liquid


1. Purpose

To provide a standard operating procedure for dispensing of solvent and liquid material in the warehouse.

2. Scope

The scope of this SOP is applicable for dispensing of solvent and liquid material in the warehouse at [company name].

3. Responsibility

Warehouse person: Dispensing of solvent and liquid materials

Warehouse supervisor: To verify dispensed material details, to record the activities in the batch manufacturing record

Manufacturing supervisor: To verify dispensed material details against the standard quantity mentioned in batch manufacturing record, to ensure calculation correctness

QA Person: To accord line clearance

Warehouse Head: To monitor the procedure compliance

4. Definitions

Not applicable

5. Procedure

5.1. Manufacturing person shall initiate a material requisition note for the required product. The requisition will contain details of material name, material code, batch number, and required date.

5.2 Warehouse person shall receive the material requisition note and plan for the material dispensing activity as per material requisition.

5.3 Bill Of Material (BOM) with Raw Material details (A.R. Number) for the batch to be dispensed shall be provided to the warehouse by the manufacturing department.

5.4 Material management software shall generate the formulation order where material details shall get arranged automatically based on FEFO (First Expiry First Out) followed by FIFO (First In First Out).

5.5 Only approved material will get populated in the list.

5.6 At a time, single batch material shall be dispensed. An open container of the materials shall be used first for dispensing.

5.7 Ensure that all required solvents or liquid materials are in the approved state before dispensing and no material is due for a retest.

5.8 Approved solvents or liquid containers shall be kept ready (through material movement route) after wiping the containers with a lint-free duster. Ensure that no leakage of solvent in solvent storage area at the time of entering into the room. Material shall be kept on the spill control pallet with adequate segregation.

5.9 Warehouse and Manufacturing personnel shall enter into the solvent dispensing area from the man movement change room.

5.10 Warehouse person shall ensure that area is cleaned for dispensing activity before the start of the activity. Accessories used for the dispensing is available with clean status label and instruments such as weighing balance are calibrated.

5.11 Use required Personal protective equipment (PPE) such as hand gloves, nose mask, Earmuff, Earplug, Goggle while working in dispensing area.

5.12 Switched “ON” the Fuming Hood and allow the area to stabilize for 5 minutes.

5.13 Ensure that Fuming Hood is working as intended.

5.14 Ensure that the temperature, relative humidity, and differential pressure are within the acceptable range.

5.15 Before starting the dispensing activity, line clearance should be done to ensure that area is cleaned, no previous product documents, and the residue is available in the area.  Line clearance checks for dispensing shall be done by the user department, followed by the QA department. Line clearance shall be recorded in the batch manufacturing record.

5.16 The dispensing activity shall be carried out under the supervision of personnel from the warehouse and manufacturing department.

5.17 Clean container shall be brought into Solvent dispensing booth / fuming hood and place it on the balance to record the tare weight.

5.18 Adequate earthing to be provided by using crocodile clip during dispensing to the solvent container, weighing balance and container in which the dispensed solvent to be stored.

5.19 During dispensing, details to be verified on the material label, such as Description of the material, Item code number, A.R. Number, Retest date, and expiry date.

5.20 Material shall be weighed as per the quantities defined in BOM using the weighing balance. Ensure that the correct capacity of the weighing balance is used.

5.21 Material shall be dispensed in the pressure vessel designed to store solvents. Solvent dedicated pump shall be used for solvent transfer. Attach the crocodile clip to solvent drum. The lid of solvent drum shall be open slowly to avoid the suddenly flow of fumes.

5.22 The solvent transfer pump shall be placed into solvent container. Compressed air operated pump shall be used to transfer the solvent from main container to the container in which the material is to be dispensed. Adjust the flow of compressed air to transfer the solvent as per requirement.

5.23 Warehouse supervisor shall verify the standard quantity mentioned in the batch manufacturing record to ensure that the correct amount of material is dispensed. Adjust the quantity of solvent as needed as per the BOM.

5.24 The dispensed material shall be labeled with details such as product name, batch number, material name, item code, A.R. Number, Lot No., and container No.

5.25 Manufacturing supervisor shall verify the quantity dispensed against the standard amount, material code, A.R. number, gross weight, tare weight, net weight, and other details on the dispensed material label and verify the correctness concerning the batch manufacturing record.

5.26 Close the lid of solvent drum and the SS container in which material is dispensed

5.27 “Cleaned” status labels of containers shall be retained at the time of dispensing of raw material and attached with the batch manufacturing record.

5.28 Ensure that the dispensed container wheels shall be cleaned before transferring from dispensing area to the manufacturing room.

5.29 Different lots’ solvent shall be issued in separate containers.

5.30 After completing dispensing, the remaining material container shall be transferred to the warehouse through the material airlock.

5.31 Used Utensils and accessories shall be labeled with the status label as “Unclean”.

5.32 At the end of dispensing, if any material physical quantity found different from material management software stock, it should be adjusted in the system up to the allowable amount. If the difference is more than the defined acceptable range, it shall be investigated.

5.33. Before starting of next batch, cleaning of area and fuming hood shall be performed.

5.34. Cleaning process shall be documented in the area and equipment logbook.

5.35 After completion of dispensing activity, personnel working in the area shall remove the hand gloves and cut them to prevent re-use of it. Discard the gloves in the waste bin.

5.36 Any spillage of material while handling shall be handled using respective ingredient Material Safety Data Sheet (MSDS).

5.37 Spill control kit with absorbent pad shall be used for any accidental spillage of material.

6. Frequency

Every batch manufacturing where solvent is part of the BOM

7. Formats

Format for Logbook of solvents and liquids dispensing (Following are the content of logbook)

Date

Product Name

Batch No.

Batch Size

Material Code

Dispensing Start time

A.R. No.

Quantity dispensed

Dispensing End time

Dispensed by

Dispensing checked by

Cleaned by Cleaning checked by

Procedure for Storage and Dispatch of Finished Goods


1. Purpose

To provide a standard operating procedure for Storage and Dispatch of Finished Goods from the finished goods store.

2. Scope

The scope of this SOP is applicable for Storage and Dispatch of Finished Goods from the finished goods store at [company name].

3. Responsibility

Finished Goods Store: Storage of finished goods, loading finished goods in the container or transportation vehicle. Placement of data logger with the finished goods to be shipped.

Quality Assurance: To release of finished goods and checking batches to be shipped and container to be used for transportation.

Logistic department: Arrangement of the vehicle from the approved transporter to ship the consignment. Preparation of documentation required for transportation and export of finished goods. To provide details to finished goods store regarding vehicle arrangement.

Approved transporter: Transportation of export consignment to seaport or airline cargo, checking documents’ adequacy for appropriateness.

4. Definitions

Not applicable

5. Procedure

1. Storage of finished goods

  • Finished goods shall be received from the packing department along with the batch details.
  • The document shall contain information about product name, product code, batch number, manufacturing date, expiry date, and packed quantity.
  • Ensure that all the containers shall have labels and quantity details. On receipt of the batch in the finished goods store, batch details shall be verified against the documents received.
  • Entry of material receipt shall be done in respective logs/ software.
  • The goods shall be stored at appropriate storage conditions as per labeled storage conditions. The batch shall be stored in the quarantine area/ under test area.
  • Location details shall be updated in the respective area log/ software.
  • Finished goods shall be arranged in the storage area in such a manner to prevent contamination, cross-contamination, and mix-ups.
  • Once QA releases the batch, it shall be transferred from the quarantine area to the approved area.

2. Dispatch of finished goods:

  • Get the weight chart for the consignment with details of batch number, container number, gross, tare, and net weight and share it with the logistic department.
  • Logistics shall arrange the container for the consignment at the plant.
  • Before consignment, check the mode of transportation. For example, if the mode of transportation is by air, the finished goods store person shall wrap the pallet with a thermal blanket.
  • Before shipment, the finished goods store person shall wrap pallets with stretch film.
  • Finished goods store person shall ensure that the arranged transporter is approved by QA department and agreement with the transporter is valid.
  • Dispatch of finished goods shall be done through only the Approved Transporter.
  • Before transportation of finished goods, the vehicle shall be checked for the vehicle’s condition and cleanliness.
  • In case the customer is arranging their transportation, detailed information regarding the transporter should be ensured. List of such customers shall be maintained by finished goods store. As and when new customers and products are introduced, the list shall be updated.
  • After the vehicle’s arrival, the finished goods store person shall inform to QA department for vehicle inspection and consignment verification.
  • Finished goods store person and QA person shall check the finished product and inspect the vehicle, loading platform, and rainproof status before loading of consignment.
  • Finished goods store person shall load the goods in the container as per the shipping document.
  • Finished goods store person shall do documentation of shipment loading.
  • When shipment needs to send with the controlled condition, finished goods store person shall use calibrated temperature sending device to check the container’s temperature and record it in the logbook.
  • Before starting batch loading activity, ensure that the container’s temperature complies with the required product storage condition mentioned on the shipping mark.
  • Ensure that temperature controlling equipment is in ON condition while loading the finished goods.
  • After completion of loading the finished goods, ensure that vehicle should maintain the required temperature.
  • Finished goods store person shall ensure that material is not damaged during the loading.
  • While loading, if required, use airbag or strapping tools to prevent goods tilting or damage during transportation.
  • It is to be ensured that the protection of finished goods is done in such a way that the vehicle is protected from calamities conditions and rain showers.
  • Before closing the shipment container, photographs shall be taken and attached with the documents for future reference.
  • Once the shipping container is filled, fix the seal and hand over the vehicle to the transporter.
  • Required commercial documents shall be handed over to the transporter.
  • Acknowledgment for shipment handover shall be taken from the driver.
  • Logistics department shall additional documents required to facilitate shipment, such as invoice, Weight Chart, Non-Hazardous declaration.
  • Dispatch documents shall be retained for product expiry +1 year or 5 years, whichever is longer.

3. Precautions during air and sea shipment:

  • Placement of data logger as per shipment validation study.
  • Checking of container cleanliness.
  • Airbag to be used to fill the empty space.
  • Cord strap to ensure pallet will remain at its place and hold the container adequately.
  • Ensure that the doors of the containers are placed adequately.
  • Ensure that thermal blanket is wrapped for an air shipment.
  • In case of shipment, mode changed from sea to air, ensure that thermal blanket is wrapped. If shipment mode is changed from air to sea, remove the thermal blanket.
  • Ensure that data loggers are placed in the shipment as defined for the respective product, customer, and mode of shipment.
  • Ensure that the data logger is ON during shipment.
  • During the rainy season, depending on transportation mode and route, additional layering of the pellet can be done using poly bags to protect the goods.

6. Frequency

Every shipment

7. Formats

  • Format for Checklist for Dispatch of Finished Goods
Product NameRecord the observations
Batch No. 
Date of shipment 
Cleanliness of vehicle 
Vehicle details 
Temperature before loading the goods 
Temperature after loading the goods 
Temperature sensor Id. 
Pallet No. 
Container numbers 
Details entered By 
Details verified by 
  • Format for acknowledgment from vehicle driver (this can be in multiple languages for understanding of driver)
Product Name:
Date of dispatch:
Information for driver to note:
1. In case of any abnormality observed during the transportation, driver needs to immediately inform to company and transporter’s main office.
2. Ensure that cooling of container is maintained as per storage condition.
3. If cooling unit malfunctions, alternate arrangement needs to be done immediately with the help of transporter’s main office.
4. To inform immediately to transport company in case of any event with the vehicle during carrying the goods.
Explained by finished goods store person:   Signature/ Date:
Acknowledged by driver:   Signature/ Date:
  • Format for transportation details:
Sr. No.Product nameCustomerDestinationMode of transportationContainer storage conditionData logger requirement
       
       
  • Format for list of approved transporter
Sr. No.Name of TransporterAddress of TransporterTypes of vehiclesValidity of Transporter agreement
     
     
     

Handling of Retest and Expired Materials


1. Purpose

To provide a standard operating procedure for management of Retest and Expired Materials in warehouse.

2. Scope

The scope of this SOP is applicable for management of Retest and Expired Materials in warehouse at XYZ Company.

3. Responsibility

Warehouse person: Identify and segregate the material which due for retest and expired on daily basis.

Warehouse supervisor: Checking of material which due for retest and expired.

Warehouse head: Overall responsibility to ensure compliance to the procedure

4. Definitions

Not applicable

5. Procedure

5.1 Handling of retest material

5.1.1 Material due for retest required to be transferred to the area designated for quarantine storage.

5.1.2 Warehouse person shall check the material under retest on a daily basis and generate a list of materials due for retest for that particular day using material management software.

5.1.3 Supervisor will verify the list and handover to the warehouse person who is responsible for material transfer.

5.1.4 Warehouse person shall transfer the identified materials, which are due for retest to the quarantine area and store the same at available space.

5.1.5 Material shall be stored in the area at suitable conditions applicable for the material.

5.1.6 Material location chart shall be updated with the new location in the material management software.

5.1.7 Material shall be labeled with Quarantine Label. Previously affixed label with Approval status shall be defaced with the marker.

5.1.8 Quality Control (QC) Laboratory will get the intimation through the material management software regarding material testing. QC will plan for the testing by considering the priority as per the production planning.

5.1.9 Once the material testing is completed, the material status will get automatically updated in the material management system based on the result generated in the laboratory information management system. The material shall be transferred to the approved material area or rejected material area based on the quality.

5.1.10 Rejected material shall be handled as per the procedure for handling of rejected materials.

5.1.11 In case of any material which needs to be used once after opening the container, it shall be tracked separately, and after dispensing, it shall be blocked with the help of QA and shall be destroyed as per the process of material destruction.

5.2 Handling of expired material

5.2.1 Warehouse person shall check the expiry status of material on a Monthly (End of the month for the next month) basis and generate a list of expired materials for that particular day using material management software.

5.2.2 Supervisor will verify the list and handover to the warehouse person who is responsible for material transfer.

5.2.3 Warehouse person shall transfer the identified expired materials and shall move to the rejected area.

5.2.4 List of materials available in the rejection room shall be updated.

5.2.5 Material shall be labeled/ stamped with ‘expired material’.

5.2.6 In case of information received from the material manufacturer for extension of material shelf life, it can be done with adequate evaluation.

5.2.7 In order to extend the shelf life, additional information regarding the stability study of material, the container closure system of material in which stability study performed, updated CoA from the manufacturer shall be acquired.

5.2.8 Once the information is received, it shall be reviewed by warehouse head and further approval from Quality Assurance Head shall be taken. Quality Assurance Head shall evaluate all the supporting data thoroughly for shelf life extension.

5.2.9 If Shelf life extension is not required then Expired materials shall be destroyed as per destruction procedure and same shall be approved by Quality Assurance Head.