pharmaceutical waste management in india
TRANSCRIPT
PREPARED BY:Aakashdeep RavalM.Pharm sem-2QARA L.J.INSTITUTE OF PHARMACY
GUIDED BY:Ms. Krupa ThulaAsst. Professor
QARA DEPARTMENTL.J.INSTITUTE OF PHARMCY
Waste disposalScrap Disposal Procedure
&Records
CONTENTSo INTRODUCTION
o DEFINITIONS
o PHARMACEUTICAL WASTE
o TYPES OF PHARMACEUTICAL WASTE
o WASTE DISPOSAL METHODS
o COLOUR CODING FOR WASTE STORAGE
o WASTE DISPOSAL PROCEDURE
o INTEGRATED SOLID WASTE MANAGEMENT
o LIQUID WASTE MANAGEMENT
o SCHEDULE M GUIDELINES
o WHO GUIDELINES
o RECORDS
o REFRENCES
02/31
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
03/31
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
04/31
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
05/31
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
06/31
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
07/31
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
08/31
INTRODUCTIONo Hospital pharmacies in the United States purchase
over 4 billion hazardous pharmaceuticals annually, generating more than 84,000 tons of hazardous waste.
o According to a U.S. Geological survey, pharmaceutical contaminants were found in 80% of sampled water, contaminating drinking water.
o In India, a city like New Delhi with about 40,000 beds generates about 60 metric tons of hospital waste per day.
o The sorting of pharmaceutical waste is a challenging issue.
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
09/31
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
DEFINITIONPharmaceutical waste is synonymous with
o drug wasteo unused or expired drugs o unused or expired prescription and over-the-
counter human drugs, veterinary drugs, diagnostic agents, and nutritional supplements.
Scrap: Materials like rejected foils, bottles, cans, tins etc. which have a resale value.
Trash: This material is to be discarded or disposed of by suitable means and don’t have a resale value. e.g. dust, unsalable materials.
10/31
PHARMACEUTICAL WASTE
o All unsealed syrups, creams, ointment or eye drops (expired or unexpired)
o All cold chain damaged unexpired pharmaceuticals that should have been stored in a cold chain but were not (for example: insulin, polypeptide hormones, gamma globulins and vaccines)
o All bulk or loose tablets and capsules. If unexpired these should only be used when the container is still sealed, properly labeled or still within the original unbroken blister packs;
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
11/31
o Any items used in cleaning up a spill (vermiculite, paper towels, etc.) must be treated as a waste pharmaceutical, either hazardous or non-hazardous.
o Waste materials containing chemotherapy drug residues or excess drugs (syringes, i.v bags, tubing, vials, etc.)
o Open containers of drugs that cannot be used
o Containers that held acute hazardous waste drugs.
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
12/31
TYPES OF PHARMACEUTICAL WASTE1. Controlled substances (Special disposal
needed):o Cytotoxic waste: Cytotoxic substances and residues (includes all items contaminated by such substances, or used in the delivery of chemotherapy for cancer treatment, and unused or discarded preparations).o Following category of drugs were also required some
special consideration required for disposalo Narcotics, o Psychotropic substances; o Anti-infective drugs, o Antiseptics and disinfectants etc..
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
13/31
2. Chemical Wastes:o Includes Pharmaceutical wastes (includes outdated,
contaminated and discarded medicines)3. Potentially infectious wastes (Biomedical
wastes):o Includes Microbiology and Biotechnology Waste
o Wastes from laboratory cultures, stocks or specimens of micro-organisms, live or attenuated vaccines, human and animal cell culture used in research and infectious agents from research and industrial laboratories
o Wastes from the production of biological, toxins, and dishes and devices used for the transfer of cultures)
o Sharp wastes includes o Needleso Scalpelso Bladeso IV spikes o other sharp objects that are potentially contaminated with infectious
and/or chemical agents and which may cause puncture or cuts
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
14/31
4. Other pharmaceuticals:
(a) solids, semi-solids and powders: – tablets, capsules, granules, powders for injection,
mixtures, creams, lotions, gels, suppositories, etc.
(b) liquids: – solutions, suspensions, syrups, etc.
(c) ampoules:– Aerosol canisters: including propellant-driven
sprays and inhalers.
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
15/31
WASTE DISPOSAL METHODS
o Waste management is the collection, transport, processing, recycling or disposal of waste materials.
o The term usually relates to materials produced by human activity, and is generally undertaken to reduce their effect on health, the environment or aesthetics.
o Waste management can involve solid, liquid, gaseous or radioactive substances, with different methods and fields of expertise for each.
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
16/31
o Waste management methods vary widely between areas for many reasons, including type of waste material, nearby land uses, and the area available.
o Constraints in funding for disposal of waste
pharmaceuticals necessitate cost-effective management and methods.
o The main way to achieve this is to sort the material to minimize the need for expensive or complicated disposal methods.
o NEXT SLIDE HAVE methods FOR IT
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
17/31
DISPOSAL METHODS TYPES OF PHARMACEUTICAL COMMENTS
(1) Return to manufacturer All bulk waste pharmaceuticalsIt’s a time consuming
method.
(2) Incineration:
o High temperature incineration (> 1200°C)
Solids, semisolids, powders, antineoplastic
Expensive method. Mainly for antineoplastic agents.
o Medium temperature incineration (max 850°C)
Powders, solids, controlled substances.
Not for antineoplastic agents.
(3) Immobilization:
o Waste encapsulation Powders, liquids, solids.Inexpensive and performed
by unsophisticated equipments.
o InertizationSolids, liquids, semisolids,
antineoplastic.
Inexpensive and performed by unsophisticated
equipments.
(4) Landfill:
o Highly engineered sanitary Landfill
Limited quantities of untreated solids,Semi-solids and powders. Disposal of
waste pharmaceuticals afterImmobilization preferable. PVC
plastics.
Worst option as it pollutes land and reduce its fertility
percentage.
o Engineered landfill
Waste solids, semi-solids and powders,
Preferably after immobilization. PVCPlastics.
Worst option as it pollutes land and reduce its fertility
percentage.
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
18/31
Open uncontrolled non engineeredDump
As last resort untreated solids, semisolids,
powders - must be coveredImmediately with municipal waste.
Immobilization of solids, semi-solids,
Powders are preferable.
Not for untreatedControlled substances
(5) Sewer and fast -flowing watercourse
Diluted liquids, syrups, intravenousfluids, small quantities of diluted
Disinfectants (supervised).Antineoplastic, and
undiluted disinfectants& antiseptics not Recommended
(6) Burning in open containers
As last resort, packaging, paper,Cardboard
Not acceptable for PVCplastics or
Pharmaceuticals
7) Chemical decomposition
Not recommended unless specialchemical expertise & materials
AvailableNot practical for quantities
Over 50 kg.
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
19/31
COLOR CODING FOR STORAGE OF WASTE IN PHARMACEUTICAL COMPANY.
Colour coding Types of container Waste categories
Yellow Plastic bags•Human anatomical waste•Animal waste•Microbiological waste•Solid waste
Red Disinfected container, plastic bags
•Microbiological waste•Solid waste
Blue/ White Plastic bags/ puncture proof containers
•Sharp wastes(needles, blades etc.)
Black Plastic bags•Discarded waste•Incineration waste•Chemical waste
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR
CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
20/31
WASTE DISPOSAL PROCEDUREo Any product requiring disposal should initially be separated
from its packaging. e.g. glass, plastic, other containers delay destruction
o Risks associated with destruction of the product -potential for product to get diverted, legitimately or otherwise during disposal sequence and contamination of ground water
o Ideally, Incineration procedures have preference over landfill. When incineration procedure is used, product in plastic or other flammable packaging may not need to be returned to bulk.
o Disposal procedure should involve agents with a proven record of dealing with such sensitive materials or use of the company personnel to accompany the material from plant to disposal.
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE
DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
21/31
PRINTED PACKAGING DISPOSAL
o Disposal of printed packaging components (labels, inserts, and cartons) poses no health risk.
o Ineffective disposal such as in the public landfill, can give rise to public concern that product may be associated with the packaging.
o Such materials should preferably be incinerated.
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE
DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
22/31
GENERAL TRASH AND SEWAGE
o Normal local services should be adequate.o Ensure that product and the packaging waste
does not get intermixed. o Internal procedures should be sufficiently
rigorous and monitored o Containers used within the plant to accumulate
waste materials should be clearly marked to denote their designated use.
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE
DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
23/31
INTREGATED SOLID WASTE MANAGEMENTo It takes an overall approach to
creating sustainable system that are economical, affordable, socially acceptable and economically effective.
o The key function of this system is collection and sorting of waste.
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
24/31
LIQUID WASTE MANAGEMENT
Description and Purpose
Liquid waste management includes procedures and practices to prevent discharge of pollutants to the storm drain system or to watercourses as a result of the creation, collection, and disposal of non-hazardous liquid wastes.
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
25/31
SUITABLE APPLICATION
Liquid waste management is applicable to construction projects that generate any of the following non-hazardous by-products, residuals, or wastes:
o Drilling slurries and drilling fluidso Grease-free and oil-free wastewater and rinse watero Dredgingo Other non-storm water liquid discharges not
permitted by separate permits.
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
26/31
LIMITATIONS
o Disposal of some liquid wastes may be subject to specific laws and regulations or to requirements of other permits secured for the construction project (e.g. Army Corps permits, Coastal Commission permits, etc.).
o Liquid waste management does not apply to dewatering operations (NS-2 Dewatering Operations), solid waste management (WM-5, Solid Waste Management), hazardous wastes (WM-6, Hazardous Waste Management), or concrete slurry residue (WM-8, Concrete waste management).
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
27/31
SCHEDULE M GUIDELINES
o The disposal of sewage and effluent from manufacturing shall be in conformity with requirement of Environmental Pollution Control Board.
o All biomedical waste shall be destroyed as per provisions of Bio-medical Waste (Manufacturing and Handling) Rules, 1996.
o Additional precautions shall be taken for storage and disposal of rejected drugs.
o Records shall be maintained for all disposal of waste.o Provision shall be made for proper and safe storage of waste
materials. o Hazardous toxic substance and flammable materials shall be
stored in suitably designed and segregated enclosed areas in conformity with central and state legislation.
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
28/31
WHO GUIDELINES
o Provision should be made for proper and safe storage of waste materials awaiting disposal.
o Toxic substance and flammable materials should be stored in suitably designed, separate, enclosed cupboards as required by national legislation.
o Waste materials o Should not be allowed to accumulate. o Should be collected in suitable receptacles for
removal to collection points outside the building o Disposed of safely and in a sanitary manner at
regular and frequent interval.
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO
GUIDELINES
o RECORDS
o REFRENCES
29/31
RECORDSo It shall contain authorized procedures for differentiating
recoverable and non-recoverable rejects.o Should include
o Date of destructiono Name of product to be destroyedo Type of destructiono Place of destructiono Cause of destruction
o Procedures for scrap which are disposed/sold on commercial basis, and precaution to be taken thereof e.g. defacing of labels on empty bulk containers.
o Quantities rejected and destroyed must be recorded and reconciled in relevant batch documents.
o Safety precautions taken while carrying out destruction must be included in the records.
o Signature of authorized person after completion of the destruction must be included in records.
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFRENCES
30/31
REFERENCES
o Willing H. S, Stoker R J, “Good Manufacturing Practices For Pharmaceuticals” Fourth Edition, 47-48.
o Potdar A. M, “Pharmaceutical Quality Assurance” Nirali Prakashan, First Edition, 7-8.
o Sharma P P “How To Practice GMPs”,Vandana Publication, Third Edition, 134.
o http://epa.gov/climatechange/wycd/waste/downloads/overview.pdf
o http://www.dot.ca.gov/hq/construc/stormwater/NS02Update.pdf
o INTRODUCTION
o DEFINITIONS
o PHARMA WASTE
o TYPES
o DISPOSAL
METHODS
o COLOUR CODING
o WASTE DISPOSAL
o INTEGRATED
SOLID
o LIQUID WASTE
o SCHEDULE M
o WHO GUIDELINES
o RECORDS
o REFERENCES
31/31
THANK YOU…
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