Disposal of Materials, Purpose:
Disposal of Materials, To establish a system for the authorization and disposal of rejected/expired materials and products. This covers the various steps that are required to be followed for destruction of rejected/expired materials and products in a safe and legal way with proper authorization.
Disposal of Materials, Scope:
This SOP applies to quality related non-complies or undesirable materials in XX Pharmaceuticals Ltd. (Both General & Cephalosporin Block) from any one of the following interface steps.
Rejected Raw & Packaging Materials
[][]Expired Retention Samples
[][]Manufacturing waste and in process waste (Both raw & packaging materials)
[][]Rejected Intermediate/Bulk Products/Batch Tails/Finished Products
[][]Trial sample for product development
[][]Laboratory waste (Reagent, analysis sample etc.)
Definitions / Abbreviation:
[][]QA – Quality Assurance
[][]QC – Quality Control
[][]PD – Product Development
[][]BMR – Batch Manufacturing Record
[][]Waste – Materials if they no longer are fit for their originally intended purpose.
[][]Non-Waste – Materials that can be recovered and reused in a process.
[][]Hazardous Waste – Waste is considered to be hazardous if it exhibits any of a number of properties related to flammability, explosivity, water/air reactivity, corrosivity, oxidizing potential, acute or chronic toxicity, ecotoxicity or infection.
[][]Non- Hazardous Waste – Waste is considered to be non-hazardous if it DOES NOT exhibit any of the properties related to flammability, explosivity, water/air reactivity, corrosivity, oxidizing potential, acute or chronic toxicity, ecotoxicity or infection.
Responsibilities:
[][]The roles and responsibility is as follows:
Concerned Department
[][]To collect, disposition and proper storage & disposal of rejected materials/products according to this SOP.
Quality Assurance
[][]To review and get prior approval for initial disposition.
HR Executive
[][]To check and monitor regular disposition activities
Senior Executive, Cost & Budget (Factory)
[][]To verifying that all the disposed items and make report for stock adjustment memo.
Head of Plant Operation
[][]Proper follow-up of overall activities
Head of Quality Assurance
[][]Approval of all the disposal activities
Procedure:
Precautions / Special instructions
[][]Wear masks, gloves & safety goggles (eye protective glasses) and other necessary precautions during destruction works and disposal of wastage and expired materials/products.
[][]Avoid scattering after completion of work.
[][]Always keep the plastic bucket/dustbin covered with lids after work.
[][]Wash the container after completion of work.
[][]Do not dispose the waste tablets and capsules directly into drain.
[][]Do not store the in-process waste for disposal for next day.
Disposal procedure for manufacturing & In-process waste from production area
[][]Departmental executives/ operators will ensure that the waste materials are segregated at sources of generation as hazardous & non-hazardous.
[][]Departmental executives/ operators will ensure the waste materials are in their respective designated containers and their physical segregation from passed, approved, quarantined or any finished good materials. They will also separate solid & non-solid waste materials.
[][]In case of new product, Product Development will assess and identify the nature of materials as hazardous & non-hazardous at development stage. Product [][]Development will notify the relevant owners about the disposal procedure of wastes.
[][]The waste packaging materials (polythene bags/cartons/labels/drums/fiber board boxes etc.) will be removed daily from the sections and transferred to salvage yard according to nature of disposal process by service people.
[][]The manufacturing related solid waste materials (waste raw materials, products, IPC materials etc.) will be removed daily from the sections.
Each working area contains separate waste bin with proper labeling for different types of waste as per annexure-V.
[][]Put all the tablets checked during in process check (IPC) for hardness, thickness, friability and weight variation in waste bin placed in respective compression room, IPC room. The same procedure will be applicable for capsule, powder for suspension, rejected tablets, and capsule from blister area and bottles which are used for leak test.
[][]Collect the dust from Dispensing, Granulation, Compression, Encapsulation and Powder filling area in the waste bin placed in the respective area except hazardous waste.
[][]Take all the waste in the washing area. Production & QCOM Executive will be present during disposal and follow up the whole activities.
[][]Take approximately 10 – 15 liters of potable water into a bucket. Dissolve any types of waste mentioned above in this water in quantity sufficient.
[][]After dissolving, transfer the dissolved wastes into washing area and dispose them into drain with plenty of water to ensure proper cleanliness of the drain.
[][]Clean the bucket using Sodium bi carbonate & Sodium Lauryl Sulphate (detergent) powder solution.
[][]Dispose the dust or tablets or capsules collected in a vacuum cleaner in the same way as described above.
[][]The manufacturing waste should have to be disposed immediately the same day of waste produced.
[][]Disposal procedure for laboratory waste (Reagent, analysis sample etc.)
[][]For laboratory waste follow the SOP “Waste management in Quality Control Laboratory” Where XX denote current version.
[][]Disposal procedure for waste generated in the Product Development Laboratory
[][]For the waste generated in the PD laboratory follow the SOP “General waste disposal procedure for product development lab.” Where XX denote current version.
[][]Disposal procedure for intermediate/bulk products/batch tails/finished products/hazardous waste from manufacturing area
[][]When a finished product/ intermediate products/ bulk product/ batch tails, hazardous waste is to be rejected, the concerned department Head shall raise “Disposal Form for Materials & Products” as per annexure-I for write-off in the part-A.
[][]The form is first to be signed by Concerned Department Head followed by concerned personnel of Factory Accounts & Budget, HR & Admin personnel, General Manager plant and approved by Head of Quality Assurance.
[][]After approval of the Disposal Form for Materials & Products, concerned department will attached the “To Be Disposed” label as per Annexure-III with the rejected materials and to be kept in a dedicated area of the respective production department before the schedule for disposal activities.
[][]The disposal activities to be carried out in the concerned department in the respective washing area.
[][]All the disposal activities will be conducted in a dedicated washing area with direct supervision of QA Executive
Tablets, Capsules & PFS : Non-Betalactam
[][]Wear appropriate Personal Protective Equipment/Clothes.
[][]Sort out the blister strips of tablets & capsules.
[][]Tear the blister strips and take out the tablets from the pouches.
[][]For PFS: Open the Alu. Cap & tear the label.
[][]Pour the powder of the bottles into a plastic bucket.
[][]Keep aside the deformed Alu. Cap, LDP stopper & spoon and send to salvage yard.
[][]Keep the Dry powder, tablets and capsules in a bucket; mix/dissolve the tablets/capsules with water and stirring.
[][]Neutralize the liquid (pH 6 – 9) by using acid/alkali. Dilute 10 – 20% of the liquid by fresh water and drain out with plenty of water or burg.
[][]Tear the printed packaging materials and transfer all the torn packing materials to the salvage yard.
Tablet, Capsules and PFS (Cephalosporin)
[][]Wear appropriate Personal Protective Equipment/Clothes.
[][]Make sufficient quantity of 0.4% (v/v) sodium hypo-chlorite solution.
[][]Sort out the products.
[][]Take out the strips from the cartons.
[][]Tear the blister strips and take out the capsules/tablets & keep in a bucket.
[][]Keep the torn blister strips into a polythene bag.
[][]For PFS: Open the Alu. Cap, LDP stopper & tear the label.
[][]Pour the powder of the bottles into a plastic bucket.
[][]Keep aside the deformed Alu. Cap & spoon and send to salvage yard.
=>Dissolve/mix the dry powder, tablets and capsules in a covered plastic bucket with previously made 0.4% (v/v) sodium hypochlorite solution and stir with a rod. Leave it overnight for at least 12 hrs.
=>Neutralize the liquid (pH 6 – 9) by using acid/alkali. Dilute 10 – 20% of the liquid by fresh water and drain out slowly the materials on the following working day.
=>Clean the drain with adequate water flushing.
=>Tear all packaging materials and transfer the torn packaging material for salvage yard.
[][]After disposal of the product/ materials, Part B of the Disposal Form for Materials & Products shall be signed by concerned person with designation who disposed the products and then jointly checked by Executive, QA and Executive, HR & Admin. and finally approved by Head of QA.
[][]All master copy of disposal records shall be maintained and kept by QA department and another copy will be sent to Concerned Department, HR & Admin Department and Cost & Budget (Factory) department.
Expired Retention Samples
[][]For expired retention sample the same procedure to be followed the procedure stated in 7.4 by raising the Authorization and Disposal Form for materials & products.
Waste Packaging Materials
[][]Collect all the in-processed waste produced from packaging area from the waste bin placed in the respective area.
[][]Tear the wastage label, carton, leaflet and put into a polythene bag by attaching “To Be Disposed” label as per Annexure-III.
[][]All wastage of cap, spoon, and dropper are to be deformed and then put into a polythene bag by attaching “To Be Disposed” label. All wastage of foils, films to be cut and put into polythene bag.
[][]All the wastage packaging materials are to be checked by Production and QA Executive daily. Then the daily waste materials sent to the dedicated salvage yard through warehouse with waste material transfer note (Annexure-IV) with proper notification to HR executive.
[][]After receiving of this waste transfer note by HR executive, this copy will be returned to respective department and to be preserved.
[][]All these packaging waste materials are kept in the salvage yard. These wastages are disposed by the third party as per company policy.
This procedure also applicable for the online rejected materials.
[][]In case of large number of online rejected materials the disposal procedure to be followed by prior approval from Head of QA following the Authorization and Disposal Form for Materials & Products.
Stock Adjustment Procedure
[][]After approval of Authorization and Disposal Form for Materials & Products for Rejected Intermediate / Bulk Products / Batch Tails / Finished Products and online rejected materials, stock adjust memo to be filled up by Cost & Budget (Factory) personnel as per Annexure-II.
[][]After approval from relevant personnel the main copy to be kept in the Cost & Budget department and another copy will be attached with the relevant Authorization and Disposal Form for Materials & Products.
[][]Finally the adjustment to be done on the ERP.
Annexure:
Annexure I- Authorization and Disposal Form for Materials & Products
Annexure II- Stock Adjustment Memo
Annexure III- Label for “To be disposed”
Annexure IV- Waste Material Transfer Note
Annexure V- Waste Collection & Disposal Procedure