Waste Disposal, Purpose:
Waste Disposal, To describe the general waste disposal procedure in product development area.
Waste Disposal, Scope:
This SOP is applicable for general waste disposal procedure for product development area of XX Pharmaceuticals Limited.
Definition of Terms:
None
Responsibilities:
The roles and responsibility are as follows:
Executive/ Sr. Executive Product Development
[][]Disposal of waste according to the SOP
[][]Preparation and timely review of the SOP.
Senior Executive, Quality Compliance
[][]Checking the disposal procedure at the time of operation
Head of Plant Operation
[][]Review the waste disposal procedure.
Head of Quality Assurance
[][]Approve the disposal activities.
[][]Implementation of the SOP.
Precaution(s):
[][]All concerned persons have to follow the SOP.
[][]Wear dust mask, safety goggles and rubber gloves during handling waste materials.
[][]Ensure that all containers are closed before sending for salvage.
[][]Keep a record in the log book for different wastes before destroying.
[][]Any deviation from the stated procedure should be documented and reported to the supervisor for corrective measure.
Waste Disposal, Procedure:
Waste originated during product development activities can be classified into five categories such as:
[][]Chemical Waste
[][]Plastic Waste
[][]Paper Waste
[][]Cotton Waste
[][]Broken/ fractured glass bottle
The rejected products shall be accumulated and stored separately in restricted areas with the label “To be destroyed”.
Chemical Waste (Solid, Blister and Liquids)
Solid waste:
[][]Solid waste consists of chemicals spread during different manufacturing stages such as: dispensing, charging, addition, de-dusting etc. These are also produced during Lab batches as the excess granules or tablet/capsule after keeping required quantities of the products for stability studies. These are disposed off as follows:
[][]Sweep off chemicals from the floor with the help of a vacuum cleaner or a brush and handy shovel and keep it in waste bin.
[][]Collect chemical dust from the collector of vacuum cleaner.
[][]Weigh and record it in a register. Fill the Annexure – I of the SOP and take approval for disposal from Manager, Quality Assurance.
[][] In presence of a Quality Compliance Officer dissolve the waste chemicals in water and pass through drain to ETP.
[][]After keeping required quantities of the products for stability studies, weigh the remaining quantities and record the quantity in a register.
[][]Fill the Annexure – I of the SOP and take approval for disposal from Manager, Quality Assurance.
[][]In presence of a Quality Compliance Officer dissolve the remaining granules and tablet/ capsule in water and pass through drain to ETP.
Blister waste:
Blisters containing tablets or capsules become waste after completion of stability studies at different conditions and storage periods and also after expiry date. These are disposed off as follows:
[][]Collect the waste blisters of different products and deblister them manually.
[][]Weigh the waste tablets /capsule and waste blisters.
[][]Record it in a register and Fill the Annexure – I of the SOP and take approval for disposal from Manager, Quality Assurance.
[][]In presence of a Quality Compliance Officer Dissolve the waste tablets /Capsule in water and pass through drain to ETP.
[][]Weigh and record the waste blisters in register book and then send to salvage yard.
Liquid waste:
[][]Liquid waste comprises mainly washings generated during cleaning of different equipment and trace of chemicals spilled during dispensing. All these are disposed off as follows:
[][]Dispose off the liquid waste through floor drain.
[][]Wipe the spillage with a wet cotton brush and dispose off the washings through floor drain. These washings will go through floor drain to Effluent Treatment Plant (ETP).
Plastic Waste
Returnable:
Returnable plastic waste comprises empty PVC drum/ cane of chemicals. All these are returned to store after destruction of labels.
Others:
[][]Other plastic waste comprises empty polyethylene bag, PVC tube, reject strip, broken plastic etc. All these are disposed off as follows
[][]Make it unusable by cutting. Keep them in waste bin.
[][]Weight the waste and record in a register.
[][]Fill the Annexure – I of the SOP and take approval for disposal from Manager, Quality Assurance.
[][]In presence of a Quality Compliance Officer send the waste to the salvage yard.
Paper Waste
[][]Expired documents/confidential company documents:
[][]Make it unusable by cutting Weight the waste and record in a register
[][]Fill the Annexure – I of the SOP and take approval for disposal from Manager, Quality Assurance.
[][]In presence of a Quality Compliance Officer send the waste to salvage yard.
Others:
[][]Paper waste comprises empty paper bag of raw materials, paper drums, rejected labels, leaflet, inner cartoons, shipper cartoons etc. All these are disposed off as follows:
[][]Make the waste unusable (except drum) by cutting and keep it in waste bin.
[][]Weigh and record it in a register. Fill the Annexure – I of the SOP and take approval for disposal from Manager, Quality Assurance.
[][]In presence of a Quality Compliance Officer send the waste for salvage.
[][]In case of drum, tear or destroy label. Weigh and record in the register book, then send to store
[][]Destroy paper bags, rejected labels, leaflets and inner cartoons by cutting.
Cotton waste
[][]Cotton waste consists of cotton bag of raw materials, unusable cotton duster etc. These are disposed off as follows
[][]Make the cotton waste unusable by cutting weight the waste and record in a register. Keep them in waste bin.
[][]Fill the Annexure – I of the SOP and take approval for disposal from Manager, Quality Assurance.
[][]In presence of a Quality Compliance Officer send the waste for salvage.
Broken/fractured glass bottle
[][]Break the unusable bottle by hammer with proper precaution, such as use mask, safety goggles, safety shoes, hand gloves and protective dress.
[][]Weigh and record in the register book.
[][]Weigh and record in the register book.
[][]Fill the Annexure – I of the SOP and take approval for disposal from Manager, Quality Assurance.
[][]In presence of a Quality Compliance Officer send the waste for salvage.
[][]All the waste disposal record forms must be stored in product development department and at the end of the year a total disposal summary will be provided to Manager, Quality Assurance.
Annexure: Waste Disposal
Annexure – I: Waste disposal request form.