ORAL DOSAGE FORM SOPs

PURPOSE

To provide a procedure for receiving, verification and storage of raw / Packing materials.

SCOPE: 

This procedure is applicable to all the incoming raw / packing materials.

5.0 PROCEDURE:

5.1 RECEIPT AND VERIFICATION.

5.1.1 When the vehicle will reach at factory gate the security personnel shall inform the concerned warehouse personnel regarding the receipt of material. Store personnel shall verify the document against PO & make an authorization on invoice & send it to security. Security personnel will receive the Papers and make entries in Security Register for Incoming RM/PM as per JSA/WH/001/F-01/R0.

5.1.2 The Warehouse Manager and the concerned shall receive the documents like Invoice/delivery challan, test certificate etc., from Supplier/Vendor.

5.1.3  Warehouse personal and shall verify documents as per packing list and ensure that the consignment is not mixed with other materials during transit and there is no contamination.

5.1.4 RM /PM must be supplied from approved vendor if it is not from approved vendor, inform to QA and Purchase department to make necessary arrangements.

5.1.5 If the material is received for the first time refer MSDS and ensure safety measures are implemented.

5.1.6 The description of the material on documents should be same as the description on the label of the containers received.

5.1.7 While unloading the materials (Solid /Liquid), the concerned Store staff shall check the condition of the Materials, damage to container, leakage/spillage of material and/or any other discrepancy which in the judgment of Plant administration or in consult with QA Head, in case of adversely affect the quality and quantity of the material shall be rejected, and stored in the Rejected RM/PM Store separately and same shall be inform to procurement department for further process.

5.1.8 The damage detail shall be recorded in the Rejected stock register (JSA/WH/003/F-01/R0).

5.1.9 In case unlabeled materials are received, after pre-entry cleaning, label them as ‘REJECTED’ and inform to procurement department and to the supplier for further actions.

5.1.10 Subsequently material receipt details for all Raw & Primary Packing materials should be recorded on “Observation on Pack” (JSA/WH/001/F-02/R0). If there is any excess materials or shortages it will be informed to the head office by email and in the meantime the excess materials will be kept in the quarantine area which will not be sampled until the decision comes from the head office. This will be informed to our plant head, QC and QA.

5.1.11 All containers should be “De-dusted” by using vacuum Cleaner and then each container is received in the quarantine store one by one, if there is smaller container size then for these types of containers stacked on small pallets/Stool for de-dusting.

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1.0 PURPOSE

To provide a procedure for dispensing of Raw materials and Packaging materials

2.0 SCOPE: 

This procedure is applicable to the dispensing of all Raw materials and Packaging Materials.

5.0 PROCEDURE:

5.1 Upon receipt of BMR/ additional Material request from the respective department, check availability of specified quantity material & AR No. based on the BMR in stock register and record the same in the BMR / additional requisition.

5.2 Even if  one  item  is  not  available, dispensing shall not be done and  the  requisition  slip  shall be  returned  to production department with the relevant remark.

5.3       DISPENSING OF RAW MATERIALS:

5.3.1    BEFORE DISPENSING:

5.3.1.1  Wear hand gloves and masks during dispensing operation.

5.3.1.2 Check that, dispensing area is clean and daily check of the balance is performed.

5.3.1.3 Switch ON the dispensing booth, wait for 10 minutes and check the manometer reading. Record the same in the respective logbooks. Operate the dispensing booth as per respective SOP.

5.3.1.4 Record all the details in Pre-dispensing check record for every batch (Annexure – 1).

5.3.1.5  If the balance check and manometer reading are not within the limits, inform ENG and affix “Under Maintenance” label and do not operate the booth until rectification.

5.3.1.6  Get the line clearance from QA department before start the dispensing operation.

5.3.1.7  Dispense the approved materials as per FIFO method. In case of any deviation in FIFO method, initiate the deviation form and handle as per the SOP “Deviation Management”.

5.3.1.8  Affix the status label or display area status with on-going process/dispensing details.

5.3.1.9  Check the availability of all dispensing Equipment’s / Tools / Polythene bags for holding dispensed material required for dispensing, near the dispensing booth.

5.3.1.10Draw approved materials for Dispensing from the racks after verification and transfer to dispensing area one by one.  “CONTAINER IN USE” materials shall be taken for dispensing, first.

5.3.1.11 Check the correctness of the AR No. on containers and tally with stock register. Check the material    name, Mfg. date, Exp. date, AR No., Retesting date and “Use before” date (where applicable) on the approved label of the containers/bags.

5.3.1.12  Verify and ensure that the required quantity is available to complete dispensing of the item. If not, identify the next available approved stock in register. Enter the applicable AR No. and Quantity issued in the Batch Manufacturing Record.

5.3.1.13  In case of product change over and whenever required; QA shall check the dispensing area prior to give line clearance.

5.3.1.14  If found satisfactory, give line clearance for dispensing and sign in the Pre-dispensing sheet.

5.3.1.15  Wherever calculations are involved, the Warehouses staff shall perform the calculation after getting necessary potency details of Raw materials through approved label on the Raw materials containers.

5.3.1.16  This shall be counter checked by QA executive. In case of two or more AR No. , calculation shall be performed accordingly in the BMR.

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1.0 PURPOSE

To provide procedure for Storage and disposal of Rejected Raw Materials and Packing Materials.

2.0 SCOPE: 

This procedure is applicable to operation and cleaning of Storage and disposal of rejected raw Materials and Packing Materials.

5.0 PROCEDURE:

5.1  QC RESPONSIBILITY:

5.1.1 Perform the sampling activity.

5.1.2 In case of QC rejection, issue the ‘Rejection note’ to Warehouses Department and ensure that “Rejected” Labels are affixed on rejected materials by QC personnel.

5.1.3 Ensure the rejected raw and packing material pertaining to respective MRV is blocked.

5.14  Inform to Warehouses Personnel and update the Rejected Stock Register (JSA/WH/003/F-01/R0) and follow the procedure as mentioned from point no 5.2.4.

5.2  WAREHOUSE RESPONSIBILTIY:

5.2.1  In case of Online Rejection by Production, Spillage of any materials Warehouse personal receives the ‘Material Return note’ along with Rejected materials duly labeled as “Returned Rejected Material”.

5.2.2  Warehouses Personnel and update the Rejected Stock Register (JSA/WH/003/F-01/R0).

5.2.3  Warehouses Personnel check for the expiry of materials in stock during the last week of every month for materials due for expiry in the next month.

5.2.4  Transfer the Rejected material to respective Rejected materials storage area under lock and key.

5.2.5  Ensure the expired materials stock are blocked on the date of expiry and update activity.

5.2.6  Enter the details in “Rejected Stock Register” (JSA/WH/003/F-01/R0).

5.2.7  On the date of expiry transfer the expired materials to rejected storage area provided under lock and key.

5.2.8  Inform Department Head & EHS for necessary action.

5.2.9  Upon receive the intimation from EHS for disposition action.

5.2.10   The disposition (destruction/sent back to supplier) to be ensured by Manager, within 60 days from the date of rejection. In case the disposition date crosses the specified time period the same shall be appropriately justified.

5.2.11   Manager ensures that for the materials where customs and legal formalities are required, dispose the same after getting clearance from customs and legal authorities.

5.2.12   Manager ensures all the legal formalities are satisfactorily cleared and rejected materials are disposed within time limit.

5.2.13   Raw and packing materials which need to be return to manufacturer / supplier shall be sent through delivery challan and necessary documents.

5.2.14   In case of in-house destruction of raw materials initiate ‘Authorization for Destruction/Disposal of material.

5.2.15   Take approval and destroy the material in presence of QA.

5.2.16   Update the ‘Material Destruction Register’ (JSA/WH/003/F-02/R0) and ensure rejected stock is debited.

5.2.17   If sample approval, QC personnel notify the Warehouse department.

5.2.18   Supervisor Inform to QC about Retesting status of Raw Materials. During last week of every month, check the Raw materials due for retest for the next month.

5.2.19   Ensure Approved Raw Material available for dispensing. 

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1.0 PURPOSE

To provide procedure for Handling of spillages in warehouse.

2.0 SCOPE: 

This procedure is applicable to Handling of spillages in warehouse and dispensing Booths.

5.0 PROCEDURE:

5.1       Any spillages/leakages/damage of raw materials, inform the superior.

5.2       Inspect the material / area and take appropriate corrective action to arrest the spillage / leakage

5.3       Based on the nature of spilled material, decide the disposition action.

5.4       In an event of any label found missing from its designated place, initiate deviation to handle the same.

5.5       In case of Raw material spillage, segregate the spilled container / bag, if required replace the original container/bag in presence of QA.

5.6       Label the container / bag with ‘‘Materials transferred from Original Container/ pack’’ as per details on original label.

5.7       Collect the spilled material in a poly bag, affix ‘Rejected’ label.

5.8       Clean the area with dry mop / vacuum cleaner followed by wet mop. Disinfect the area.

5.9       In case of Inflammable solvent, Acid corrosive materials and Hazardous substance Use appropriate personnel protective equipment’s provided in chemical spill kit.

5.10     Remove the spilled container/bag from the area.

5.11     Cover spilled material with 3M absorbent. Collect the absorbent waste in a container for disposal.

5.12     Clean the area with dry mop / vacuum cleaner followed by wet mop. Disinfect the area.

5.13     In case of liquids/oily materials spillage collect spilled material in a polybag /container and sent to washing area, dilute with plenty of water and drain.

5.14     Check the weight of spilled container/ bag to arrive at the loss quantity.

5.15     In case of excessive loss inform department head / QA head and investigation to be carried out.

5.16     Initiate ‘Authorization for Destruction’ and dispose the spilled material.

5.17     In case of control substance inform the regulatory/statutory department with appropriate documents and take necessary approvals for disposition.

5.18     Update the stock in Register/System.

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1.0 PURPOSE

To provide procedure for Handling of Returned Raw and packing materials from production.

2.0 SCOPE: 

This procedure is applicable to Handling of Returned Raw and packing materials received from Production.

5.0 PROCEDURE:

5.1       Raw and packing materials shall be returned to warehouse from production under the following circumstances, but not limited to.

5.1.1    Change in production plan.

5.1.2    Cancellation of batch after dispensing.

5.1.3    Quantity left over after completion of batch

5.1.4    Excess quantity issued for batch (Foils, PVC, PVDC, and Shrink Film).

5.1.5    Materials rejected during process.

5.2       Receive the material return note and check for details.

5.3       Ensure the materials are duly labeled as “Returned Approved material” and stretch wrapped.

5.4       Ensure raw and packing material issue tags on each “Returned Approved Material”.

5.5       Check the quantity of each material as per “Material Return Note” and receive.

5.6       Retain the raw and packing material issue tags and “Material Return Note” warehouse copy.

5.7       Transfer the materials to storage racks along with “Returned Approved Material label”.

5.8       In case of original container not available, transfer Returned Approved Materials to in-house containers.

5.9       Affix “Material transferred from original container / pack label on container.

5.10     Ensure the Returned approved materials are taken for dispensing for next available batch.

5.11     In case of Returned Rejected Material, ensure the goods are received with “Returned Rejected Material” label.

5.12 Transfer the material to ‘Rejected Storage Area’ and perform WM activity.

5.13 Update the ‘Rejected Stock Register’.

5.14 Inform Department Head and SCM for further disposition action.

5.15 In case of In-house destruction of rejected materials, initiate Authorization for destruction and destroy after approvals.

5.16  Update ‘Material Destruction Register’ & Update stock register and perform WM activity.

5.17 In case of Printed material returns, Check and ensure no coded materials are received from production.

5.18 Transfer the materials along with Returned Approved material label to respective storage racks.

5.19  Update stock in register and perform WM activity.

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1.0 PURPOSE

To provide procedure for Issuance of Packing Materials.

2.0 SCOPE: 

This procedure is applicable to Issuance of Packing Materials.

5.0 PROCEDURE:

5.1 Supervisor will receive the BOM/Approved AMR/MR from packing department and generate the pick list manually.

5.2 Ensure First in First out is followed for materials as per pick list. Refer process order for standard quantity of materials to be issued for batch.

5.3 Check the availability of required Quantity and S.R. No. in register.  Identify the storage location of packing material as per pick list. Check the correctness of material like material name, item code, S.R. No, retest date on approved label and make arrangements to draw materials from the racks.

5.4 Enter the printed packing materials storage area.

5.5 Issue the printed packing materials in presence of authorized personnel and once the activity is completed, lock the area.

5.6 Ensure ‘In- use’ / ‘Returned approved materials’ are taken first for issuance.

5.7 During issuance of packing materials, details like number of packs/units to be recorded in BOM i.e. printed cartons, literatures, container, caps, PVC Trays, Silica gel etc.

5.8 For materials to be issued in numbers apart from printed material, issue exact quantity / round off to nearest to the issued quantity and ensure issuance of material in intact boxes.

5.9 PM Warehouse shall issue balance quantity of packing materials by taking into consideration of carry forward quantity if applicable. Carry forward quantity shall be recorded in respective BOM with sign and date of packing executive.

5.10 Check for the appropriate S.R. No. material name and item code for the respective packing material.

5.11 Ensure weighing balance is clean and performance check is done.

5.12 Take one issue tags for each material / S.R. Nos. after issuing the materials affix issue tag to dispensed materials. After completion of issuance, attach the copy of pick list to the BOM and send to packaging department.

5.13 Issue Primary packaging materials in S.S cage trolleys. Ensure printed packing materials are issued in cages with lock & key. Materials like PVC, PVDC and plain foil should be issued in S.S cage trolley.

5.14 In case of Foils, PVC, PVDC and Shrink film issue whole roll. Round off the issuance quantity to nearest intact roll quantity.

5.15 For Foils, PVC and PVDC record roll wise weighing details in BOM and ensure rolls are covered with polythene bags. If rolls are intact, issue the same with supplier pack. Ensure tertiary packing material provided by the vendor is removed from the material before issuance.

5.16 In case of caps and containers issue the same supplier / manufacturer or follow the BOM instructions irrespective of FIFO, to avoid difference in moldings / sealing.

5.17  In case of containers and caps, quantity mentioned on the supplier pack shall be considered while issuance.

5.18  Container & caps shall be issued in intact boxes and wherever required for loose quantity issue by counting / weighing basis.

5.19     Issue secondary packaging materials in S.S cage trolleys. Ensure materials are issued in cages with lock & key.

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1.0 PURPOSE

To provide procedure for dispatch of Finished Goods.

2.0 SCOPE: 

This procedure is applicable to dispatch of finished goods from warehouse.

5.0 PROCEDURE:

5.1 Ensure packing list updated and product is ready for dispatch.

5.2 Ensure all finished goods dispatched with minimum 80% shelf life.

5.3 If product shelf life is less than 80%, take approval from marketing department, if required initiate a test request form to QA for Re testing.

5.4 Perform carton numbering as per the packing list.

5.5 Verify the partial quantity shipper(s) for its quantity and labelling. Make signature with date.

5.6 Perform wiring for the cartons as per the requirement.

5.7  Stretch wraps the individual boxes in case of Air shipment/customer requirement.

5.8   Ensure COA received from QC.

5.9 Release Product in documents.

5.10 On receipt of dispatch intimation from logistics department, ensure the goods are ready for dispatch.

5.11     In case of splitting / re packing of batches as per the Sale order requirement, The goods shall be transferred to packing department from the FG Warehouses based on the sale order quantity / packing list along with Splitting record.

Note: If the revised SO requires loose shipper quantity then loose shipper of initial stock shall be transferred for splitting along with other shippers.

5.12 Segregate the goods as per the sale order requirement prepare and affix appropriate shipper labels on the shippers as per the shipping marks mentioned in the sale order.

Note: carry out Packaging operation as per the normal packing procedure. After completion of splitting process, pack the remaining quantity with the loose shipper of the initial stock by correcting the quantity of loose shipper.

5.13 After completion of repacking and shipper labelling, transfer the goods to FG Warehouses, along with the duly signed splitting record

5.14 Verify the transferred goods and retain the copy of the request form in Warehouses and send the original to packing department for attaching the same in the BPR.

5.15 In case of consignments requires inspection from external agency based on customer requirement, ensure inspection of the same and inspection process to be accompanied by Warehouses operator / supervisor.

5.16 During inspection process, if any samples are removed from the shippers, ensure, same is replaced with samples if, available for replacement.

5.17 In case of non-availability of samples for replacing, the sampled quantity should be mention on the shipper and properly identified with labels /footnote on shippers.

5.18  After completion of inspection process, send the original reports to logistics and copy of inspection report shall be signed by the persons, who accompanies and verifies the inspection process and to be retain in Warehouses.

5.19 Prepare the shipping bills, Invoice, packing list, Annexure and non-returnable gate pass and sales tax form.

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1.0 PURPOSE

To provide procedure for receipt and storage of Finished Goods.

2.0 SCOPE: 

This procedure is applicable to receipt and storage of finished goods in warehouse

5.0 PROCEDURE:

5.1       Examine Boxes for proper labelling and sealing.

5.2       Check each box for details such as Name of Finished Goods, Number of Boxes, Batch number,   Manufacturing date, Expiry date.

5.3       Ensure production and QA department personnel duly signed on FGTN.

5.4       Check product details and quantity in FGTN, verify physical quantity and sign.

5.5       Retain one copy of FGTN and receive goods.

5.6       Receive finished goods from Packaging department.

5.7       Warehouse the FG in the FG Warehouses and release from QC, QA will do the stamp approved then   it is transferred to the Approved FG storage. In case of any rejection in the FG or product recall it will Warehoused in the FG rejection location.

5.8       In case of ‘Returned drug products’ received, inform department head and handle the goods as per      SOP for further process.

5.9       In case of batches meant for Regulatory submission, receive the goods along with Manual FGTN.

5.10      In case of Exhibit batches, ensure each packed shipper is labeled as ‘EXHIBIT BATCH NOT FOR       SALE’ along with common shipper label.

5.11      Warehouse in dedicated area under lock and key provided for Exhibit batches/ validation batches.

5.12      Warehouse the received goods on racks/pellets as per product storage condition.

5.13      Record the temperature once in a day by using and update the temperature register.

5.14      Perform WM activity and Update the details in location index.

5.15      Update receipt details in relevant statutory records.

5.16      Update packing list in register as per the Sales order.

5.17      In case of finished product withdrawn for samples from existing stocks, remove the required quantity           from Loose/Intact shipper.

5.18      Generate new shipper label and affix to shipper, sign the label with date. Deduct the stock in register             and revise the packing list.

5.19      In case of ‘Validation’ batches cleared for sale and distribution by QA department. Perform WM    activity, Prepare packing list.

5.20      Ensure QA department release of the products.

5.21      Inform and co-ordinate with logistics for dispatch of products.

5.22      In case of goods expired during storage, Inform department head for further actions.

5.23      For expired exhibit batches refer to QA / RA department for further action through department head.

5.24     Inform QA for sampling to carry out Re testing of finished goods for products Warehoused more         than one year, on case to case basis as required for dispatch based on marketing requirement.

5.25      If QC rejected the product after Re testing, Transfer the goods to Rejected storage area.

5.26      Transfer the expired goods to Rejected goods storage area.

5.27      In case of space constraints in Rejected goods storage area, stretch wraps the goods, tie red colour     tape and segregate from the other products.

5.28      Affix status label and update ‘Rejected stock register’.

5.29      Inform department head and Initiate ‘Authorization for destruction’ for rejected goods and take   necessary approvals.

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