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As we know that stirrer is used for Mixing of solid ingredients in the solvent.

1.0 OBJECTIVE:

To verify and document the installation, operation and performance of Overhead Stirrer with Tank-XYZ L and to ascertain that the machine operates as designed and performs to meet the predefined acceptance criteria.

2.0 SCOPE:

The scope of this qualification report is limited to Overhead Stirrer with Tank-420 L having ID no. XYZ .

3.0 RESPONSIBILITIES :

Maintenance Officer/Executive: To prepare qualification report and co-ordinate the entire qualification activity.

Quality Assurance Officer/Executive: To witness the qualification study and ascertain that the study is conducted as per the protocol.

Production Officer/Executive: To execute qualification study in co-ordination with other departments.

Head Maintenance: To review the qualification documents.

Head Quality Assurance: To approve the qualification report.

4.0 EQUIPMENT  DESCRIPTION :

Equipment comprises shell, bottom dish, lid, flange, ball valve, agitator, flame proof motor, variable frequency drive (VFD) and emergency OFF button. All contact parts is SS 316 L and mirror finished.

5.0 ACCEPTANCE CRITERIA:

 Qualification of the equipment should meet the acceptance criteria outlined in the following steps.

• Calibration status report of Multimeter device

Sr.No.	Device	Acceptance criteria	Observation	Checked by date/sign
1	Multimeter	It shall be calibrated for its performance.

• Installation verification report

Sr.No.	Check points	Acceptance criteria	Observation	Checked by date/sign
1	Check the condition of the equipment on receipt visually.	Visually there should not be any abnormality.
2	Check the levelling of the equipment using level indicator.	Air bubble shall be at centre position of level indicator.
3	Check the major components and their electrical cables for housing and anchoring.	Major components and their electrical cables shall be securely housed and anchored.

• Technical and sub components specification verification report

Sr.No.	Check points	Acceptance criteria	Observation	Checked by date/sign
1	Tank diameter	2 feet or more
2	Electrical	Flameproof
3	Discharge	1” BSP outlet with ball valve
4	Speed control	960 rpm propeller agitator with speed control VFD.
5	Discharge height	2 feet mm from ground level
6	Agitator	1 HP, Speed variable up to 960 rpm, shaft diameter 20 mm, Top tank mounting.
7	Castor wheels	Shall be provided for ease in movement of the machine.
8	Motor	1 HP, Make: Hindustan
9	Emergency push button	Make: Tecknic
10	Variator	Make: Delta

• Utility verification report

Sr.No.	Utility	Acceptance criteria	Observation	Checked by date/sign
1	Electricity	Three phase, 410 V ± 5% and 50 Hz ± 5%

• Safety features verification report

Sr.No.	Safety features	Acceptance criteria	Observation	Checked by date/sign
1	Earthing	Earthing shall be provided to equipment.
2	AC motor	AC motor shall be covered with SS guards.
3	Emergency stop	Emergency stop button shall be provided on operating panel.

• Material of construction (MOC) and  test certificate  verification checklist

Sr.No.	Components	Acceptance criteria	Observation	Checked by date/sign
1	MOC of contact parts i.e. shell, lid, dish, flange and ball valve	SS 316 L and mirror finished.
2	Motor	It shall be tested for its performance.
3	AC drive	It shall be tested for its performance.

• Operational verification report

Sr.No.	Operation	Acceptance criteria	Observation	Checked by date/sign
1	Turn the main ON/OFF switch at ON position.	Red indication lamp should glow.
2	Press the start button.	Green indication lamp should glow and equipment should start.
3	Rotate speed spot in clockwise direction step by step up to last point.	Agitator speed shall be raised gradually.Rotation of agitator shall be smooth and noise and vibration free.
4	Press the emergency stop button.	Rotation of agitator shall be stopped immediately.

Sr.No.	Operation	Acceptance criteria	Observation	Checked by date/sign
5	Release the emergency stop button and re-start the equipment.	Agitator of equipment should re-start.
6	Press the stop button.	Green indication lamp should turn OFF and equipment should stop.

• Performance verification report    Performance of equipment is verified by simulating the normal operation for preparation of colour coating solution. After completion of preparation, physically checked the colour coating solution for its appearance. Observation of procedure followed for preparation of colour coating solution:

            Product name:                                           

            Batch No.:

           Colour coating solution quantity:

Sr.No.	Procedure	Observation	Checked by date/sign
1	Stirring: Add the Isopropyl Alcohol (IPA), Hydroxy Propyl Methyl Cellulose (HPMC) and Methylene Chloride into 420 L tank, stir for 15 minutes.

Sr.No.	Procedure	Observation	Checked by date/sign
2	Milling: Add Colour, Isopropyl Alcohol (IPA) and Titanium Dioxide into container and stir manually for about 10 minutes and pass through Colloidal Mill for 15 minutes milling.
3	Stirring: Add the step No. 2 solution and polyethylene glycol into step No. 1 with continuous stirring for 30 minutes.
4	Filtration: Filter the coating solution through 100 # sieve.

• Acceptance criteria:
  • Colour coating solution should be clear and free from fines of colour material.
  • Mechanical operation should be satisfactory.
  • Observation of colour coating solution:

           _____________________________________________________________________

           _____________________________________________________________________

           _____________________________________________________________________

           _____________________________________________________________________

           _____________________________________________________________________

           _____________________________________________________________________

6.0 DEVIATION REPORT:

Sr. No.	Deviation (s)	Justification for acceptance criteria	Impact on installation, operation and performance

7.0  CHANGE CONTROL:

Mention change control number if any

8.0 LIST OF ANNEXURE :

Mention annexure number if any

9.0 SUMMARY OF QUALIFICATION AND CONCLUSION :

Mention in details i.e what parameters you have checked and what is your observation

10.0 CERTIFICATION OF QUALIFICATION :

  Qualification is satisfactory                                                                   Yes/No

  Hence Overhead Stirrer with Tank-150 L is suitable for routine use.    Yes/No

                                                                                                                           Head – QA

PROCEDURE

 (For alert limit)

• If the colony forming units exceed the alert limit

a) Increase the frequency of cleaning from once to twice a shift.

b) Ensure that the disinfectants are used as per schedule mentioned in respective SOP

    and Cleaning of the processing area is carried out as per respective SOP .

    (For action limit)

• If the colony forming units exceed the action limit, investigate / check the following whether

• Entry / Gowning procedure is followed.

• Cleaning is done as per SOP in processing and filling area.

• Disinfectant schedule is followed as per respective SOP

• Prolonged Maintenance job performed if any.

• Personnel traffic in the area is increased.

• Major Power shut down has occurred.

• Positive pressure in the area is disturbed.

• Operator with history of adverse fingerprint reports worked in the area.
• Time of plate exposure.

• Any other incidence, which can increase the bioburden of the area, took place.

• Inform to QC dept. through QA dept. in writing the outcome of above investigation with Products / Batches manufactured and filled during the period.

• During the investigation period, increase the frequency of cleaning to twice a shift.

• Request QC dept. to identify the organism and suggest suitable disinfectant for the organism identified.

• Proceed as per the suggestions given by QC dept.

Procedure :

1. Warehouse head or designee shall receive communication from supply chain or PPIC department about the supply of raw material to the manufacturing facility.
2. On receipt of the vehicle, security department of the facility shall inform to warehouse supervisor about the arrival of material. Security person shall collect the documents from the transporter and handover to the warehouse department. The documents shall be material invoice, certificate of analysis, Material Safety Data Sheet (MSDS).
3. On receipt of the documents, warehouse person shall check the documents against purchase order, material entry into the Electronic Material Management System and vendor approval status and supplier approval status.
4. The documents received from the supplier should possess the purchase order number on the document to ensure receipt of correct material at the time of receipt.
5. Material manufacturer’s address on Certificate of Analysis (CoA), and container label must be matched with approved vendor list. While checking the address, company name, plot number, address, street name, pin code and all other minute details should be checked and ensure compliance.
6. In case of material manufacturer as well as supplier, details of manufacturer as well as supplier with address must have to be in line with the approved list in the received documents.
7. In case of material manufacturer’s address is not mentioned on CoA or container, batch number on CoA shall be verified against batch number available on container label. Batch number should be matched with each other and full address in-line with approved vendor list must have to be match with either CoA or material container label.
8. Once all documents found compliant, warehouse personnel shall allow the vehicle to enter in the factory premises.
9. At a time only one vehicle shall be attended by warehouse person. The vehicle shall be taken to the receipt bay. It should be placed in such a way that vehicle should not be open in open roof.
10. Vehicle should be verified for its cleanliness, smell and it is received with what other kind of materials.
    Vehicle should available in clean condition; it should not have any abnormal smell and condition, it should not have received with any poisonous chemical, poisons, insecticides, food material etc. vehicle inside condition should be dry.
11. Material shall be unloaded on the receipt bay. In case of multiple batches received, it shall be unloaded batch wise on clean pallets.
12. After unloading the material, warehouse personnel shall de-dust the materials outer surface of each container with vacuum cleaner or clean dry duster.
13. Material pallet should be verified at the time of receipt. It has to ensure that the wooden pallet should not have preservative treatment of halogenated-phenolic compound and Pallet certificate must have to be acquired at the time of receipt ensuring above requirement.
14. The received material shall be transfer on the company’s Stainless Steel (SS) pallets. Material pallet shall be taken into the material movement air lock. Before taking the material into the airlock and while opening the door of airlock, air curtain shall on to break air movement from outer side to inside and to prevent the contamination.
15. Material shall be ensured as per material receipt checklist. The checklist shall contain following information:
    • Purchase Order
    • Certificate of analysis from the manufacturer, Approved Vendor and supplier
    • MSDS
    • Storage condition of material
    • Cleanliness of vehicle
    • Smell of vehicle for any abnormality
    • Spillage of material in the vehicle
    • Possibility of Material contamination because of any other means.
    • Material should not accompany food, harmful chemical such as pesticides, controlled substance etc.
    • Integrity of the seal
    • Seal number of container should be matched with serial numbers provided by manufacturer when they have dispatched the material from their facility
    • The integrity of the containers
    • Container physical condition – material container should not have any damage
    • Pharmacopoeial grade
    • Material labeled for complete address of manufacturer
    • Data logger must have received with cold chain materials
    • Pallet certificate to ensure that the pallets are not treated with halogenated-phenolic compound
    • Pre-sterilized material must have to be verified for sterilization evidence as applicable i.e. Gamma eradiation evidence, ETO (Ethylene oxide) etc.
    • Weigh the material for gross weight. The weight of gross weight should not be differing from 2.5 % of the weight specified on the container.
16. Once the material is taken into the air lock, air clock shall be closed. Material shall be de-dusted using vacuum cleaner or lint free duster.
17. When receipt of material any discrepancy with respect to above point is noted, record the same in the checklist. Inform to the warehouse head and Quality Assurance (QA) person.
18. In case of condition of material is not acceptable, QA person shall reject the material by affixing the rejected label on the specific container or entire consignment depending on the situation.
19. The identified defect can be classified as follows:
    • Critical Defects: Damaged container and material is spilled, material exposed to the environment, missing seal, less than acceptable tolerance.
    • Major Defects: Outer container is damaged or deformed but inner bag found intact.
    • Minor Defects: Containers with dent surface but integrity is maintained.
20. Record the rejection in material discrepancy note and it shall be signed by warehouse and QA person. Depending on the types of defect, material can be returned to vendor after completion of documentation.
21. In case of material is rejected and cannot be sent to manufacturer back immediately, it shall be stored at appropriate storage condition as per label claim.
22. When receipt of material, if any label found torn but information is intact, the label can be laminated with lamination film to keep the material label information intact.
23. On satisfactory verification of material, material inward entry shall be done in the material management software.
24. In case of material outer container found damaged but inner container is intact, inner bag shall be transfer to new similar container (material of construction and specification of the container should be same. Label from original container should also be affixed to new container.
25. Once the material inward done in the material management software, it shall be labeled with quarantine labels and placed at designated location.
26. While entering the information in the material management software, care should be taken to ensure that correct information is entered and second person shall verify the information for its accuracy.
27. Batch number and expiry date are critical information for the traceability and validity of the material.
28. Expiry date shall be entered in the system as follows:
    • Allocate the expiry date based on date specified on CoA and container label.
    • If the expiry date is not specified and other terminology is used by material manufacturer such as valid up to, best before, use before, this information shall be considered as expiry period of the material.
    • In case if the container does not have expiry period but re-test period only, the retest period shall be considered as expiry. In such cases, the expiry date can be extended when manufacture provide supporting stability data to support shelf life extension. Such cases should be handled through appropriate QMS tool.
29. In case of cold chain material, it is required to ensure that material received along with data logger. The data shall be downloaded and reviewed for any excursion. If temperature excursion is noted, the event shall be investigated and recorded. Impact of excursion shall be evaluated before it is release for use.
30. While receipt and transfer of material which is sensitive to static electricity/ static charge, adequate measure such as earthling of container should be done before material handling.
31. In case of any exposure of material to human, instruction provided in the MSDS should be followed .

1. Purpose

To provide a standard operating procedure for management of Rejected Materials in warehouse.

2. Scope

The scope of this SOP is applicable for management of Rejected Materials in warehouse .

3. Responsibility

Warehouse person: Storage of rejected material in rejected material area

Warehouse supervisor: Checking of the documents regarding rejected materials

Warehouse head: Overall responsibility to ensure compliance to the procedure

Head QA: Approval of rejection and disposal of rejected material

4. Definitions

Not applicable

5. Procedure

5.1 Source of rejected material would be any of the following:

i. Damaged material during material receipt

ii. Discrepancy noted during receipt of material

iii. Material rejection during testing

iv. Material rejected because of the quality event during manufacturing

v. Material is expired

vi. Material no longer required to be used in the facility

vii. Product return and recall

5.2 Procedure for rejection handling when the material is rejected during testing:

5.2.1 During testing, if the material gets rejected, the QC analyst shall generate a rejected material certificate of analysis (CoA) and rejection labels according to number of containers.

5.2.2 On rejecting the material in the system, material stock shall be automatically transferred from quarantine/ under test status to blocked/ rejected status in material management software.

5.2.3 QA person shall affix the rejection label on rejected material containers.

5.2.4 Once the QA person affixes the rejected material label, warehouse personnel shall transfer the material to the rejection area and make the necessary entry in the rejected material logbook.

5.2.5 If Raw material or Packaging material gets rejected, the information shall be shared with the procurement department for financial transactions.

5.2.6 Raw material can be returned to the material manufacturer or destroyed at factory premises depending on commercial agreements.

5.2.7 Printed packaging material cannot be returned to the material manufacturer. It must be destroyed at factory premises. Except for printed packaging material, it can be destroyed at factory premises or returned to material manufacturers depending on commercial agreements.

5.3 Procedure for the handling of rejection during material receipt:

5.3.1 If the material is found damaged/ unacceptable as per material receipt procedure during receipt, the warehouse person will record the observation in the observation sheet and intimate it to the Quality Assurance (QA) department through intimation form. Based on the verification, the QA person shall affix the rejection label on the containers, which will not be in the condition to accept for use.

5.3.2 Warehouse personnel shall transfer the rejected materials to the rejected material room.

5.3.3. If material is rejected during receipt of material, record the rejection into the outright rejection form. The material can be returned to the material to the material supplier or destroyed at factory premises.

5.4 Procedure for the handling of rejection during manufacturing or packing operations (online rejection):

5.4.1 While the manufacturing or packaging process is in the progress, various instances where material rejection could happen. For example, defective packaging material observed during operation, the material is not performing as intended, machine setting rejection, material spillage, etc.

5.4.2 In the above cases, the user department shall initiate the online rejection form and get it approved by the department head and QA. Then, QA will affix the rejection label on materials or material containers.

5.4.3 User department will submit the material to the warehouse and the online rejection form to store in the rejected material area. However, in case of spillage of raw material, it needs not to transfer to the rejection area. It shall be recorded in respective batch records, and material shall be destroyed as per material destruction procedure by the manufacturing department.

5.4.4 For material returned to the warehouse, material movement transactions to be done in the material management software.

5.4.5 The material can be returned to the material to the material supplier or destroyed at factory premises.

5.5 Procedure for management of expired material:

5.5.1 In case material is expired, warehouse personnel shall affix the expired material label or stamp [as procedure defined by an organization] over the available label on the container.

5.5.2 Warehouse personnel shall transfer the material to the rejection area. Record the details in the rejection logbook.

5.5.3 Initiate the destruction report and, after approval of the destruction report, destroy the material.

5.6 Procedure for the destruction of rejected, expired, or unusable material:

5.6.1 Warehouse person shall fill the material destruction requisition form and get it approved from the operational head and quality assurance head.

5.6.2 After approval of the destruction requisition note, warehouse personnel initiates the material destruction process.

5.6.3 Printed aluminum foil, PVC, PCV-PVdC film shall be destroyed in such a way that it will not be in the form of usability. For example, the material can be destroyed using an industrial crusher machine or using drill machine.

5.6.4 Labels, cartons, leaflets, or any other packaging material shall be destroyed using a shredding machine or destroyed manually. Material can be defaced using ink in such a way that it cannot be reused.

5.6.5 Raw material and product can be destroyed as per approved procedure by the organization. Various options are available, such as transfer material to the effluent treatment plant, send to a shared effluent treatment plant (commercially provided service), incinerators, or send to the approved agency that performs destruction activity.

Note :

The rejected material shall be stored with the storage condition applicable for specific materials. This is to facilitate material return to the manufacturer if need. If the storage condition is not maintained, the material will no longer remain usable if the material manufacturer wants to reprocess the material or use it for any other purpose.

Appropriate safety precautions shall be used while handling rejected material and destruction of material. Personal protective equipment shall be used, and Material Safety Data Sheet shall be available for reference in case of any accidental exposure or to prevent any hazard.

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

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 Name	Record 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 name	Customer	Destination	Mode of transportation	Container storage condition	Data logger requirement

• Format for list of approved transporter

Sr. No.	Name of Transporter	Address of Transporter	Types of vehicles	Validity of Transporter agreement

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.

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