cGMP and Regulatory Updates

1.0 OBJECTIVE To lay down a procedure for Consumption and accounting of Excess/Shortage material received from the vendor. 2.0 SCOPE This SOP is applicable to Raw and Packing Material Warehouse. 3.0 RESPONSIBILITY Officer - Warehouse. 4.0 ACCOUNTABILITY Asst.Manager – Warehouse 5.0 PROCEDURE 5.1 Weigh and label (Loose container label) for all materials after each issue. 5.2 Check the remaining available physical quantity with the recorded SAP R/3 stock. 5.3 At the completion of a particular consignment, check the physical stock with SAP R/3 stock. 5.4 Prepare an Excess/Shortage certificate(as per Annexure enclosed ) for the quantity in excess/shortage. 5.6 Update the stocks in the SAP R/3 system as & when the Excess/Shortage certificate is Approved and Authorized. 5.6 The posting of issues in SAP R/3 system related toExcess quantity than the specified norms as below, is done onl...

1.0 OBJECTIVE To lay down a procedure for Handling of loose containers, of raw materials. 2.0 SCOPE 2.1.0 This SOP is applicable to dispensing area 3.0 RESPONSIBILITY Officer Warehouse 4.0 ACCOUNTABILITY Assistant Manager-Warehouse 5.0 PROCEDURE: 5.1.0 After dispensing of material,container & inner polybag of the loose material to be closed properly. 5.1.1 Weigh the loose container and record the Gross weight on the label. 5.1.2 Based on the original tare weight calculate the net weight of the loose material and record the net weight on the label as per annexure attached. 5.1.3 Sign the label and affix the loose container label on the container over the earlier loose container label after verifying the details. 5.1.4 Before affixing the loose container label strike off the earlier loose container label. 5.1.5 Send back the loose container to warehouse through the material exit box after dedusting and cleaning 5.1.6 The same loose container to be taken first for next dispensing.

1.0 OBJECTIVE To laydown a procedure for Operation of Hi-Reach Truck. 2.0 SCOPE This SOP is applicable to Raw Material ,Secondary packing Material and Finished Goods Warehouse Hi-Reach Trucks, Capacity: 1500 Kg 3.0 RESPONSIBILITY Operator 4.0 ACCOUNTABILITY Executive Warehouse / Executive Services 5.0 PROCEDURE 5.1 Precautions 5.1.1 Check for Hydraulic Oil leakage and arrest. 5.1.2 Ensure that charger plug is removed from batteries. 5.2 Pre Start Up 5.2.1 Check for distilled water level in the cells of the battery unit and top up if necessary. 5.2.2 Check for specific gravity of the pilot cells that to be 1240 mm of Hydrometer. 5.2.3 Connect truck plug to the battery plugs. 5.2.4 Select mode of truck direction with direction lever. 5.3 Set Up 5.3.1 Set the rear wheel steering in straight. 5.3.2 Set forks clear from the ground 5.4 Operation 5.4.1 Sit firmly in the driving seat. 5.4.2 Insert the key in the key switch and ...

1.0 OBJECTIVE To lay down a procedure for material sent for job works and its stock accounting. 2.0 SCOPE 2.1.0 Raw Materials & Primary packaging materials. 3.0 RESPONSIBILITY Officer - Warehouse and Executive-Supply Chain Management Department. 4.0 ACCOUNTABILITY Asst.Manager – Stores & Excise and Executive -Supply Chain Management Department. 5.0 PROCEDURE 5.1 Supply Chain Management Department will coordinate with warehouse department on job works. 5.2 Material to be sent out for job work only on the advice of Supply Chain Management Department. 5.3 The details of the material to be sent for job work such as Item description,quantity received,date of receipt,invoice number against which received & its date,quantity being sent,nature of job work,place or unit where job work is to be done,expected date of return of finished good are to be given to Excise Department (at Factory) one day in advance. 5.4 Assemble the require...

1.0 OBJECTIVE To laydown a procedure for Operation of Battery Operated Pallet Truck. 2.0 SCOPE This SOP is applicable to Finished Goods Packing Material Warehouse Battery Operated Pallet Truck, Model: Commuter /1115, Capacity: 1500Kg 3.0 RESPONSIBILITY Technical Assistant. 4.0 ACCOUNTABILITY Executive-Warehouse and Executive-Services 5.0 PROCEDURE 5.1 Precautions 5.1.1. Check and arrest any oil leakages . 5.1.2. Ensure that the plug is removed from the battery after charger is switched off. 5.2 Pre Start Up 5.2.1. Check for distilled water level in the cells of the battery unit and top up if necessary. 5.2.2. Check for specific gravity of the pilot cells to be 1240mm of Hydrometer. 5.2.3. Ensure that battery cable connections are tight and that cell caps are dry and clean. 5.2.4. Check for load carriage and forks are free from visible defects i.e deformation, cracks or excessive wear 5.2.5. Ensure that brakes are functioning correctly. 5.3 Set Up 5.3.1...

1.0 OBJECTIVE To lay down a procedure for Operation of Electric Pedestrian Operated Pallet Truck. 2.0 SCOPE This SOP is applicable to Raw Material Stores Electric Pedestrian Operated Pallet Truck Type: EJE20, Capacity: 1500 Kg 3.0 RESPONSIBILITY Technical Assistant 4.0 ACCOUNTABILITY Electrical Executive 5.0 PROCEDURE 5.1 Precautions 5.1.1 Check for any Hydraulic Oil leakages and arrest. 5.1.2 Ensure that plug is removed from the battery after charger is switched off. 5.2 Pre Start Up 5.2.1 Check for distilled water level in the cells of the battery unit and top up if necessary. 5.2.2 Check for specific gravity of the pilot cells and to be at 1240 mm of Hydrometer. 5.2.3 Ensure that battery cable connections are tight and that cell caps are dry and clean. 5.2.4 Ensure that battery plug is securely connected. 5.2.5 Check for play in the steering system. 5.2.6 Check for load carriage and fork tins are free f...

1.0 OBJECTIVE To lay down a procedure for Receipt of excess Raw/ Packing Material from Production. 2.0 SCOPE Raw Material, Packing Material Warehouse and Production hold area. 3.0 RESPONSIBILITY Assistant / Officer - Warehouse Assistant / Officer - Production. 4.0 ACCOUNTABILITY Assistant Manager - Production and Assistant Manager - warehouse. 5.0 PROCEDURE 5.1 Excess packing material to be received with proper document through Stock Return Note (SRN) only. 5.2 Stock Return Note (SRN) contains the following details. A) S.No B) Date, Product and Batch No. C) S.No of materials. D) Code E) Item F) Quantity returned G) Analytical Report No H) Quantity Verified by signature and date. I) Reasons for return / remarks. 5.3 Stock Return Note (SRN) to contain the signatures of Officer – Production,Quality Assurance Personnel and Assistant Manager - Production. 5.4 Material being returned has to be labeled w...

1.0 OBJECTIVE To lay down a procedure for Receipt of “On-line Rejected Materials”. 2.0 SCOPE Production, Packing hold area and dispensing area. 3.0 RESPONSIBILITY Officer- Production / Officer - Warehouse 4.0 ACCOUNTABILITY Assistant Manager - Production and Asst.Manager -Warehouse. 5.0 PROCEDURE 5.1 On-line rejected materials to be received with On-line rejection note duly signed by the Assistant Manager - Production./Quality Assurance. 5.2 On-line rejected material to be labelled as “On-line rejects”. 5.3 On-line rejected labels are to be signed by the Officer Production /Officer - Quality Assurance Department. 5.4 Stock return note to be raised by the Officer - Production for returning the On-line rejects and counter signed by Quality Assurance. 5.5 The stock return note to contain the S.No. and Date of On line Rejection with reasons. 5.6 The On-line rejected material to be sent to Dispensing room properly labelled along with a Online rejection note. 5.7 The On-line rejected materia...

1.0 OBJECTIVE To lay down a Procedure for receipt of labels. 2.0 SCOPE Packing Material Warehouse. 3.0 RESPONSIBILITY Officer - Warehouse. 4.0 ACCOUNTABILITY Asst.Manager -- Warehouse 5.0 PROCEDURE 5.1 Labels received from the suppliers are cross-checked with Delivery Challan for quantity by Warehouse Assistant/officer. 5.2 Quantity is checked by counting 50/100 Nos. and taking the weight of the same, the remaining total consignment is weighed. 5.3 Goods Received Note (GRN) has to be prepared in SAP

1.0 OBJECTIVE To lay down a procedure for Opening & closing of Raw/Packing /Finished Goods/and Engineering material Warehouses. 2.0 SCOPE 2.1. Raw Material / Packing Material / Finished Goods Engineering material Warehouses. 3.0 RESPONSIBILITY Assistant / Officer - Warehouse. 4.0 ACCOUNTABILITY Asst.Manager - Warehouse 5.0 PROCEDURE : 5.1.1 At the beginning of every working day the Warehouse Key to be taken by Assistant / Officer - Warehouse from the security by making necessary entries in Key’s Register (Maintained by -Security). 5.1.2 Security to hand over the Key to the person Authorised to draw the Raw Material / Packing Material Finished goods/ & Engineering material Warehouse keys. 5.1.3 Security to ensure the drawee signature and counter sign in the Key register. 5.1.4 In the absence of authorised person Security Officer to handover the keys to the person named by Assistant Manager - Warehouse on written request. 5.1.5 Immediately on op...

1.0 OBJECTIVE To lay down a procedure for Handling and Storage of Flammable and Hazardous Materials. 2.0 SCOPE Raw Material Warehouse and Solvent Yard. 3.0 RESPONSIBILITY Assistant / Officer / Executive - Warehouse. 4.0 ACCOUNTABILITY Asst.Manager - Warehouse. 5.0 PROCEDURE 5.1 All the flammable items to be identified and a specific area to be allotted. 5.2 The following instructions to be strictly followed in monitoring the area. 5.2.1 The place of storage to be safe guarded by fencing to restrict the movement of people. 5.2.2 Materials to be unloaded in tankers with pipe line connections. 5.2.3 While unloading the material, they are to be handled properly . for example pressurized drums to be unloaded with the help of tyres to avoid blasting due to sudden impact. 5.2.4 No live wires to be passed through the area where inflammable materials can be exposed to the sparks. 5.2.5 No smoking in the area is allowed. 5.2.6 The material is to be complete...

1.0 OBJECTIVE To lay down a procedure for “Stock Verification and Reconciliation” of raw material and packing material. 2.0 SCOPE Raw Material, Packing Material Warehouses, and Solvent Yard. 3.0 RESPONSIBILITY Officer - Warehouse. 4.0 ACCOUNTABILITY Assistant Manager - Warehouse. 5.0 PROCEDURE 5.1 Stock verification and reconciliation of all the material in the warehouse is done as below. 5.1.1 Create a Physical Inventory document in SAP with reference to inhouse batch number in all working days & take printout of the same. 5.1.2 Note the physical stock against the SAP stock in the Physical Inventory document. 5.1.3 Post the physical stocks in SAP. 5.1.4 Assess the variance & prepare Excess/Shortage certificate after completion of the stock against that particular in-house batch number as per SOP No:XXXXX. 5.2 The above verification and reconciliation should be done in addition to the perpetual stock verification done during d...

1.0 OBJECTIVE To lay down a Procedure for Disposal of Obsolete Materials. 2.0 SCOPE This SOP is applicable to Raw and packing material Warehouses of Formulations Units 3.0 RESPONSIBILITY Officer - Warehouse. 4.0 ACCOUNTABILITY Assistant.Manager - Warehouse 5.0 PROCEDURE 5.1 Materials which are no more in use and lying in the Warehouse idle for more than six months has to be informed to the Supply Chain Management Department in writing. 5.2 Supply Chain Management Department to explore any alternative exits with Formulations Research and Development. 5.3 Obsolete material to be stacked on top slot of the rack duly labelled. 5.4 Write-off note to be generated by Supply Chain Management Department based on the decision taken on the disposal. 5.5 Destroy write-off materials within 10 days from the date of receipt of duly approved “Write-off “ authorization form. 5.6 Provide proof of destruction copy to the concerned person at Central Excis...

1.0 OBJECTIVE To lay down a Procedure for Disposal of on line rejections 2.0 SCOPE 2.1.0 Area 2.1.1 Raw & Packing Material Warehouse. 3.0 RESPONSIBILITY Officer - Warehouse 4.0 ACCOUNTABILITY Asst.Manager - Warehouse 5.0 PROCEDURE 5.1 Online rejections should be received from Production on authorized documents “ON-LINE REJECTION NOTE” only as per the Annexure-1 5.2 “ON LINE REJECTION NOTE” to be signed by Executive -Production and Executive - Quality Assurance Departments. 5.3 Online rejected materials to be received with clear Online Rejected labels signed by the Officer - Production and Officer - Quality Assurance Departments. 5.4 The action plan regarding the remaining qty. of the particular consignment which is Online rejected ,should be clearly mentioned in the On-Line Rejection Note. 5.5 Warehouse to forward the On-Line Rejection Note to Purchase Department for suitable action within 3 days. 5.6 Less than 0.5 Kg. ...

1.0 OBJECTIVE To lay down a procedure for intimation of shortages and damages of Incoming Goods. 2.0 SCOPE This SOP is applicable to all Warehouses of Formulations Units. 3.0 RESPONSIBILITY Assistant /Officer - Warehouse. 4.0 ACCOUNTABILITY Asst.Manager - Warehouse 5.0 PROCEDURE 5.1 If any shortage or damage in incoming Goods found, the same has to be mentioned on the Delivery Challan before acknowledging the receipt. 5.2 The damages should be checked in presence of Quality Assurance personnel / the supplier / transporter. 5.3 If the damage is on the outer container / packing the same should be changed in presence of Quality Assurance 5.4 Shortages has to be indicated in Goods Received Note and inward actual quantity received and inform the same with in 24 hrs to the Purchase Department. 5.5 If the consignment is extensively damaged and Quality Assurance confirms not fit for receiving, do not accept and act as per Purchase...

1.0 OBJECTIVE To laydown a procedure for Cleaning of Dispensing Tools 2.0 SCOPE This SOP is applicable for Raw Material Warehouse at Formulations Units. 2.1 Area 2.1.1 All the dispensing areas - Raw Material Warehouse 2.1.2 Scoops, Spoons and servers. 3.0 RESPONSIBILITY Assistant / Officer -Warehouse and Dispensing Chemist -Production. 4.0 ACCOUNTABILITY Assistsnt Manager - Warehouse and Assistant Manager - Production. 5.0 PROCEDURE 5.1 Keep the once used (i.e., one material) dispensing tools such as scoops, spoons and big size server spoons in the box containing polybag as specified “accessories to be cleaned” 5.2 On completion of each batch dispensing, arrange for cleaning of used dispensing tools in the wash room. 5.3 Ensure cleaning person to wash the tools with purified water and final rinsing with purified water. 5.4 After wash, tools to be wiped with a fresh lint-free cloth. 5.5 Ensure the drying and cover the same ...

1.0 OBJECTIVE To lay down a procedure for Storage of Raw and Primary Packing Materials. 2.0 SCOPE This SOP is applicable to Raw Material Warehouse. 3.0 RESPONSIBILITY Assistant / Officer - Warehouse. 4.0 ACCOUNTABILITY Asst.Manager – Warehouse. 5.0 PROCEDURE 5.1 All material to be stored at temperature and relative humidity as specified in Annexure-1. 5.2 Record the temperature & R.H of Warehouse 5.3 Status label has to be affixed neatly to all material container possibly adjacent to the original Manufacturers label. 5.4 Materials should be neatly stacked on HDPE pallets and should be convenient for issue. 5.5 Clear PVDC films are to be stored in cool rooms. 5.6 Load on each pallet should be moderate and not exceed 500 kgs. Stack the material properly and uniformly on pallets. 5.7 Materials should not be protruding outside the pallets. 5.8 Arrangement of materials on pallets should be convenient for physical chec...

1.0 OBJECTIVE To lay down a procedure for Preparation of Goods Received Note for Raw and Packing materials. 2.0 SCOPE 2.1 Raw Material and Packing Material Warehouse. 3.0 RESPONSIBILITY Officer - Warehouse. 4.0 ACCOUNTABILITY Executive - Warehouse / Asst. Manager – Stores & excise. 5.0 PROCEDURE 5.1 For all the material received, prepare a Goods Received Note (GRN). 5.2 Prepare GRN immediately upon receipt and send the Certificate ofAnalysis (COA ),mentioning the GRN No.,to Quality control Dept.. 5.3 Note the GRN No. and Date on the Delivery challan/Invoice and file the same. 5.4 Raise fresh GRN for materials in case of subsequent reapproval after receiving the duly approved Non Conformance Report. 6.0 REVISION 6.1. Due to SOP review date expiry.

1.0 OBJECTIVE To lay down a procedure for operation of de-contamination booth. 2.0 SCOPE Raw material and Primary Packing material Warehouse. 3.0 RESPONSIBILITY Executive - Warehouse. 4.0 ACCOUNTABILITY Asst. Manager - Warehouse. 5.0 PROCEDURE 5.1 PRECAUTIONS 5.1.1 Ensure that the chain guards must be closed. 5.1.2 Containers should be placed on the conveyor, ensure that it should not touch the frame. 5.2 PRE START UP 5.2.1 Ensure for cleanliness of conveyor rollers. 5.2.2 Check the cleaning of suction filter, in case of any dust, get it cleaned. 5.3 SET UP 5.3.1 Set the selector switch in required mode i.e., Forward or Reverse. 5.4 OPERATION 5.4.1 Inform the warehouse personnel inside warehouse to organize pallets for unloading the material and to open the inside shutter. 5.4.2 Switch on the mains. 5.4.3 Start the side air blower by operating push button. 5.4.4 Start the top suction blower by operating push button. 5.4....

SOP: Cleaning Procedure for Raw Material Stores Dispensing Equipments Procedure For every drug substance its dedicated equipments is used. On each piece of equipment name of the drug substance for which it is reserved has been engraved. Dispensing equipment's used for excepients is not dedicated. However, cleaning procedure for all the equipments is same. After completing the dispensing operation, the dispensing equipment is carefully wrapped in a polythene bag and placed in a plastic box, which has been labeled as “USED SCOOPS, SPATULAS FOR CLEANING”. The Equipment is scrubbed with 2.0% TEEPOL solution and rinsed under running tap. To remove sticky substances, the equipments are rinsed with hot water and scrubbed with 2.0% TEEPOL solution after rinsing under running tap water. The equipment is rinsed with distilled water and allowed to drain. Then the equipment is sprayed with 70% IPA and dried with hand held drier. The cleaned and dried equipment ...