Standard Operating Procedure for Scrap Management

  

1.0       OBJECTIVE

             To lay down a procedure for disposal of rejected Material as per scrap managements.

2.0       SCOPE

 This procedure is applicable to all the departments.

    To lay down the documented procedure for collection, storage and disposal of scrap generated from  process,  machines or men to avoid the cross contamination.

3.0      RESPONSIBILITY

The following table lists the key roles and responsibilities related to this procedure.

Designation	Responsibilities
HR department/ Account & Purchase department/ Department Head / Designee	·     To follow the procedure as per SOP
Head - Quality Assurance	·     To effective maintenance of the SOP in all the applicable areas.

4.0      PROCEDURE

4.1       Generation of Scrap

4.1.1     Scraps are generated from process, machines, Packing, Analysis, Dispensing and day to day working.

4.2  Collection of scrap

4.2.1                                                        Collected scrap shall  be sent to scrap yard by house keeper of that department.

4.3  Types of Scrap

4.3.1      Generally empty composite drums with lead of different size should be segregated according to the height of composite drums in a scrap yard.

4.3.2      Every department heads have responsibility to remove original Labels on composite drums before putting it in a scrap yard.

4.3.3      Rejected Polythene bags used in Production, Packing, Store, and Dispensings shall be torn & put up in big polythene bag & Staggered in scrap yard.

4.3.4      Iron Drums, Plastic Barrels, Rejected plastic cans, Containers of different size, Plugs, Caps,  PVC foil & Aluminium printed waste foil, corrugated boxes, plastic strips, Printed rejected Labels shall be torn and stored in a scrap yard for disposal or sale.

4.3.5         Drums, torn foil, torn corrugated box, torn polythene etc shall be sold to approved and reliable vendor.

4.4       Disposal of Scrap

4.4.1    Disposal of the Scraps shall be followed as per below procedures accordingly.

4.5    FIBRE DRUMS/ PVC DRUMS/ M.S. DRUMS/ PLASTIC CONTAINERS

4.5.1  Collect all the Fiber drums/ PVC drums / M.S. drums/ Plastic containers which are to be disposed after   

          consumption of material from it.

4.5.2  Deface the approved label or printed matter on Fibre Drums by using indelible ink or by using permanent

          Marker, so as to scratch the printed matter on it.

4.5.3  Deshape the drums with the help of hammer and send them to scrap yard for further disposal.

4.6    POLYTHENE BAGS /NYLON BAGS /PAPER BAGS

4.6.1  Collect all the bags, after consuming the material, deface the label and printed matter with permanent

          marker pen or indelible ink so that the printed matter is not readable.

4.6.2  After defacing the label, send the empty bags to the scrap yard for further disposal.

4.7     REJECTED ALU. FOILS AND PRINTED PACKING MATERIALS

4.7.1  Rejected Material which is lying in the rejected area can be destroyed after instruction from QA and Unit        

          Head through “Material Destruction Note”.

4.7.2  Store Head shall ensure that before destroying the material the destruction note shall be approved by  

          Store Head, QA Head and Unit Head.

4.7.3  The material should be destroyed in presence of Q.A person and record is maintained in the  

          “Discrepancy cum rejection Register”.

4.7.4  After destruction, the signatures of above representative are taken and copy is to be given to concern

          department. Original copy is to be retained by stores department.

4.7.5  The printed packaging material is not send back to party, the material is to be destroyed in the factory  

          Premises only.

4.7.6  The Printed packing material and alu foil is destroyed by shredding or cutting.

4.7.7  After the destruction activity, Debit the excise duty of the destructed material with proper entries in excise records and reverse the Cenvat. Submit the copy of destruction note to Account Dept. to raise the debit note to the supplier.

4.7.8  All collected and generated scrap is disposed off by authorized scrap agent through HR department/Account/purchase departments.

4.7.9 At the end of month or as per requirement, prepare a list of materials which are to be expired in the same  month.

4.7.10  Dispose off the materials as per the category mentioned in Annexure – I.

4.7.11  Dispose off the materials in presence of supervisor and safety officer only. 

4.7.12  Use hand gloves, safety goggles, mask and other required protective means.

4.7.13  Maintain the duly signed and verified record.

4.8      Disposal procedure for contaminated Glassware

4.8.1  Wear latex gloves and disposable face mask.

4.8.2  Collect all microbiologically contaminated materials including petri-plates, tubes, lyophilized cultures ampules  culture slants / stabs, flasks.

4.8.3  Put all the material into stainless steel (SS) container and put the SS container into vertical portable autoclave.

4.8.4  Run the vertical portable autoclave according to SOP for 20 minutes

4.8.5  After completion of Autoclaving, the liquid medium should be drained while hot, with running water and then wash the reusable glassware as per procedure for washing of glassware according to SOP.

4.9  Disposal procedure for contaminated plastic ware

4.9.1  Take all the disposable material into autoclavable plastic bag and put all the disposable contaminated material into SS container and run the vertical portable autoclave according to SOP and send all the material to disposal storage area.

4.9.2  Disposal of media filled ampoules / vials

4.9.2.1 Autoclave the contaminated vials in terminal sterilizer in production.

4.9.2.2  The non contaminated vials should be drained in effluent treatment plant and empty vials should be  crushed in vial crusher.

4.10  Disposal of contaminated mops and latex gloves

4.10.1  The contaminated mops/tissue papers and latex gloves are used over the disinfected cultures on surfaces during any spillage and shall be put in poly bags before putting in discard bins and sent all the material to disposal storage area.

4.11  Disposal of Biological indicators

4.11.1  The biological indicators run as positive controls or indicators showing growth after running in sterilization cycles (if any) during validation studies shall be discarded after autoclaving along with other discard.

4.12  Sterility Canisters

4.12.1  The media of sterility canisters not showing any growth shall be drained into the sink after adding 5-10 ml      

            of 2.5 % disinfectant solution as such per 100 ml of media to be discarded.

4.12.2  Sterility canisters showing growth shall be placed in autoclavable plastic bag and put the bag into SS   container.

4.12.3  Run the vertical portable autoclave according to SOP for 20 minutes

4.12.4   Send the empty canisters, vials, needle and other waste articles to disposal storage area.

4.13   Used Kit from Biomeriuex identification system.

4.13.1  Place all the used kit into in autoclavable plastic bag and put bag in SS container. 

4.13.2  Run the vertical portable autoclave according to SOP for 20 minutes

4.13.3  Send the kit and other waste for disposal storage area.

4.14 Procedure for Proper Disposal of Expired Finished Goods

4.14.1 Intimation given by Store department for Expiry of Finished goods to Central Excise Department, along  

 with application stating the details of products i.e. name of products, Batch Number, Mfg date, Expiry date  & qty. to be destroyed & proportionate Cenvat Credit to be reversed in cenvat register.

4.14.2  The stocks will be transferred from unrestricted area to Rejected area.

4.14.3  QA/QC Shall transfer such stocks to Block Area in SAP system, then the BSR person will transfer

       physically the same in Rejected Room.

4.14.4  After getting approval from Central Excise Department, destruction Note shall be prepared.

4.14.5  Destruction will be carried out in presence of Store Person & QA Department.

4.14.6  Expired Finished Goods is destroyed as per SOP for destruction of material.

4.14.7  Original copy of destruction note sent to Account department for their records.

4.15  PROCEDURE for disposal of control sample:

         Control sample will be taken for disposal one year after the expiry as per the following procedure :

4.15.1    Blister & Strip packed tablets and capsules: 

4.15.1.1  The Carton/Catch cover shall be depacked and contents shall be defoiled and shall be collected in a    

             double layer poly bag.

4.15.1.2  The carton/catchcover/insert/MB box etc shall be destroyed by shredding.

4.15.1.3  The contents (Tablets/Capsules) shall be destroyed by dissolving in a container with water/crushing.    

                These will than be poured into the pit of ETP plant.

4.15.2     Bulk packed tablets & capsules :

4.15.2.1  Empty the contents in a double polythene bag.

4.15.2.2  Bulk container shall be deshaped /crushed & disposed in a drum /container at the garbage area.

4.15.2.3  The labels shall be destroyed in the shredder.

4.16     Powders packed in laminated pouches or vials: 

4.16.1  Empty the contents in a container with water than these slurry shall be poured into the pit of ETP plant.

4.16.2  Pouches shall be destroyed by means of crushing in the shredder.

4.17    Liquids packed in vials, bottles or jars: 

4.17.1 Unseal the container and pour the contents in water and then pour into the pit of ETP plant.

4.17.2  Store the empty containers in a drum. Remove the labels and destroy all batch printed packing   materials by shredding.

4.17.3  Wash the drum with tap water and keep it in the specified area

4.18     Raw Materials, Active Ingredients and Bulk Drug Substances: 

4.18.1  Empty the contents in the double polythene bag.

4.18.2  Empty the contents in a container with water and then pour it into the pit of ETP plant.

4.18.3  All the activity shall be performed in the presence of QA supervisor.

4.19 Procedure to dispose the waste into the Effluent Treatment Plant

4.19.1  Segregate all in process wastage material and collect in poly bags.

4.19.2  Transfer it to washing area.

4.19.3  In washing area pour all wastage material in HDPE container having pasted label of “IN PROCESS    

          WASTAGE MATERIAL” and water in it.

4.19.4  Mentioned the HDPE container as “IN PROCESS WASTAGE MATERIAL”.

4.19.5  Transfer all wastage which was poured in container to ETP (Effluent Treatment Plant) with the label

          mentioning the area, type of wastage, qty., date, and sign.

4.19.6  In process waste material should not be kept more than 24 hrs. in manufacturing area and Handed over to the EHS person.