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.

Standard Operating Procedure for Hold Time Study Period for Dispensed Raw Materials, Inprocess and Bulk Finished Product

1.0              Objective

To lay down a procedure for Hold Time Study of dispensed raw materials, intermediate products, bulk and finished products to establish acceptable holding period that intermediate and bulk product can be held, pending the next processing step, without producing results outside the acceptance criteria for the quality of the material.

2.0       Scope

This procedure is applicable to QA Department for performing hold time study during manufacturing of products (raw material, bulk and ready to pack) in company premises. The other concerned department is Production, Warehouse and Quality Control.

3.0              Responsibility

3.1              Officer QC shall be responsible for testing and generation of analytical raw data.

3.2              Executive/Officer QA shall be responsible for execution of Hold Time Study as per protocol.

3.3              Head QA & Head QC shall be responsible for approval of protocol, review of result and evaluation of quality attributes.

4.0              Accountability

Head QC and Head QA shall be accountable for the compliances of this SOP.

5.0              Procedure

5.1              Starting point of the storage period (Hold Time) shall be considered from the completion date of each processing step/stage. For example, in case of compression

started on 10/06/15 and completed on 12/06/15, the starting date of hold time shall be considered as from 12/06/15.

5.2              Material shall be stored in same condition as given in the respective BMR.

5.3              All critical operation and process parameter that would affect the product quality along with room condition during hold time shall be monitored and recorded or attached during the entire hold period. For example:

·         Product temperature in case of temperature sensitive product.

·         Light requirement in case of light sensitive product.

·         Starch binder temperature throughout hold time period.

5.4              The containers in which hold time samples shall be stored should be same pack as shall be used in production.

5.5              All in process stages shall be monitored for hold time. Manufacturing stage along with sampling intervals and tests to be carried out for hold time study as per Annexure-I.

5.6              For new product, establishment of hold time of bulk finished stages shall be based on its product characteristics.

5.7              Sampling at different intervals of hold time shall be done in manufacturing cubicle having status as “CLEANED”. If it is done in storage area, it shall be under the LAF and to be ensured that all other containers are in closed condition.

5.8              Hold time study shall be performed in following conditions:

·         Change in storage condition.

·         Change in formulation. For example addition or deletion of ingredient.

·         Change in manufacturing process. For example, change in granulation method.

·         For new formulation.

5.9              Storage of materials shall be as follows:

5.9.1                    Dispensed Raw Material shall not be stored for more than 5 days at controlled conditions in well closed SS container with status label. If the storage period exceeds, reweighing of material shall be done before use either in store or production area depending upon the quantity of material.

5.9.2                    Heat sensitive product or cold chain product shall be stored at 2°C - 8°C along with the remaining consignment.

5.9.3                    Sifted Raw Material for granulation/blending/ lubrication shall be stored in well closed IPC/SS container containing double polythene bag, for not more than 7 days. If the storage period exceeds, sifting of material with appropriate mesh size shall be done before use and the same shall be recorded in respective BMR with sign and date.

5.9.4                    Binder Solution:

·         Freshly prepared binder solution shall be used for manufacturing the batch.

·         The binder shall be stored in well closed SS container/IPCs after preparation.

·         Starch binder solution shall be used within 5 hours and other binder within 8 hours. If the storage period exceeds, the binder solution shall be discarded.

·         If composition of binder is same for different product or multiple strength of same product, then perform hold time study of binder in any one product or strength. This study shall be valid for rest of the strength or product.

5.9.5                    Sized Granules:

·         The granules after sizing shall be stored for not more than 7 days in a clean and dry IPC / SS bin / SS container containing double polythene bag. If the storage period exceeds, then LOD / Water Content shall be verified before start activity and same shall be attached with respective BMR.

5.9.6                    Lubricated Granules:

·         Lubricated granules shall be stored in controlled condition for not more than 45 days in well closed SS container/IPC with status label.

·         For blend of individual strength product, which are not dose proportional perform hold time study.

·         For blend of multiple strength product, which are dose proportional perform hold time study for blend on lower strength.

5.9.7                    Uncoated /Compressed Tablets (as a inprocess stage for coated tablets):

·         Compressed tablets ready for coating shall be coated within 90 days.

·         For compressed tablets of different strengths, which are dose proportional perform hold time study on higher strength.

·         If multiple strengths of compressed tablets that are not dose proportional, then perform hold time for each strength.

·         If multiple strengths of compressed tablets are not dose proportional, but having same composition then hold time study of lower and higher strength shall be performed.

·         Hold time study is not required to perform on the tablets if there is change in description of tablets related to debossing without any alteration in the physical parameters of tablets like average weight, hardness, thickness etc.

5.9.8                    Coating suspension:

·         Freshly prepared coating suspension shall be used for manufacturing the batch.

·         Suspension shall be agitated/ stirred continuously before using.

·         Coating solution shall be used within 24 hours. If storage period exceeds 24 hours, discard the coating suspension and use freshly prepared coating suspension.

·         If composition (coating material, vehicle) of coating suspension of different products or multiple strengths of same product is same then perform hold time study of coating suspension of any one product/ strength of product. This study shall be valid for rest of all strengths/products.

·         If coating suspension is different for multiple strengths or different products, the hold time study of coating suspension shall be for individual strength/ products.

5.9.9                    Coated Tablets:

·         For coated tablets of different strengths, which are dose proportional, and having same composition of coating suspension (coating material and vehicle) then perform hold time study of coated tablets on higher strength.

·         If the multiple strength for coated tablets has different composition of coating suspension (coating material and vehicle) then hold time study shall be performed for coated tablet of each strength.

·         If the multiple strength of coated tablets are not dose proportional but having same composition, then hold time study shall be performed on lower and higher strength.

5.9.10                Blend for Capsules:

·         Blend for capsule shall be stored at appropriate condition for not more than 45 days in a well closed IPC/SS container containing double polythene bags with status label.

5.10          Sampling Procedure for Hold Time Study:

5.10.1                Use cleaned accessories during sampling.

5.10.2                Use PPEs during sampling.

5.10.3                While sampling in the area, ensure that all stainless steel containers are closed except from which sample to be withdrawn.

5.10.4                After sampling close the polythene bag taking proper precaution to avoid contamination.

5.10.5                For sampling of microbiological test sample:

·         Use sterile accessories (spatula/ spoon) during sampling.

·         Wear sterile hand gloves while sampling.

·         Remove Aluminium wrapper of sampling accessories such as spatula/ spoon or bottle/polythene bag.

·         After sampling close the sterile polythene bag/ bottle taking proper precaution to avoid contamination.

5.11          Action in case of hold time exceeds  

5.11.1                If hold time period exceeds at any stage, a “Sample Analysis Requisition” shall be sent to QC for tests mentioned in Annexure-I (Format No. CS/QA063/F01-XX).

5.11.2                If hold time at various stages for any products and bulk finished stage for existing product exceeds during any batch manufacturing, then Production Department shall raise “Intimation of Exceed of Hold Time Period of Product” as per Annexure-II (Format No. CS/QA063/F02-XX) and send to QA and QC along with “Sample Analysis Requisition”.

5.11.3                If the inprocess/ bulk finish product fails during analysis, it shall be handled as per SOP No. CS/QA/023.

5.11.4                If the stability chamber, where the hold time samples are kept for the hold time study is malfunctioned and not rectified within 24 hours, the hold time samples shall be shifted to backup stability chamber. This shall be documented in planned deviation report, which shall be evaluated and approved by Head QA.

7.0              Reference

Annex 4: General guidance on hold-time studies: (WHO Technical Report Series, No. 992).