This document outlines procedures for waste disposal and record keeping at a pharmaceutical company. It defines pharmaceutical waste and describes different types including cytotoxic, chemical, infectious, and other pharmaceutical wastes. Methods for disposal are provided, such as return to manufacturer, incineration, immobilization, landfill, and sewer discharge. Color coding for waste storage and integrated solid waste management approaches are also discussed. The document emphasizes the importance of proper sorting, handling, and disposal of pharmaceutical waste.

1. Waste disposal
Scrap Disposal Procedure
&
Records

2. CONTENTS
o 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
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
02/31

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. INTRODUCTION
o Hospital pharmacies in the United States purchase over
hazardous pharmaceuticals
more than 84,000 tons of
annually,
hazardous
4 billion
generating
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

10. 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
DEFINITION
waste is synonymous with
Pharmaceutical
o drug waste
o 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

11. 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

12. 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

13. TYPES OF PHARMACEUTICAL WASTE
1. 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 disposal
o 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

14. 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 Needles
o Scalpels
o Blades
o 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

15. 4. Otherpharmaceuticals:
(a) solids, semi-solids and powders:
– tablets, capsules, granules, powders for injection,
mixtures, creams, lotions, gels, suppositories, etc.
(b) liquids:
– solutions, suspensions, syrups, etc.
including propellant-driven
(c) ampoules:
– Aerosol canisters:
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

16. 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
or
reduce their effect on health, the environment
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

17. 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

18. DISPOSAL METHODS TYPES OF PHARMACEUTICAL COMMENTS
(1) Return to manufacturer All bulk waste pharmaceuticals
It’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 Inertization
Solids, 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 after
Immobilization 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. PVC
Plastics.
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

19. Open uncontrolled nonengineered
Dump
As last resort untreatedsolids,
semisolids,
powders - must be covered
Immediately with municipalwaste.
Immobilization of solids,semi-
solids,
Powders arepreferable.
Not for untreated
Controlledsubstances
(5) Sewer and fast -flowing
watercourse
Diluted liquids, syrups,intravenous
fluids, small quantities of diluted
Disinfectants(supervised).
Antineoplastic, and
undiluteddisinfectants
& antiseptics notRecommended
(6) Burning in open
containers
As last resort, packaging,paper,
Cardboard
Not acceptable forPVC
plastics or
Pharmaceuticals
7) Chemical decomposition Not recommended unlessspecial
chemical expertise & materials
Available
Not practical forquantities
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

20. 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

21. WASTE DISPOSAL PROCEDURE
o 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

22. 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

23. 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

24. INTREGATED SOLID WASTE MANAGEMENT
o 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

25. 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

26. 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 fluids
o Grease-free and oil-free wastewater and rinse water
o Dredging
o 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

27. 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

28. 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

29. WHO GUIDELINES
o Provision should be made for proper and safe storage of
waste materials awaiting disposal.
o Toxic substance and
stored in suitably
flammable materials should be
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

30. RECORDS
o It shall contain authorized procedures for differentiating
recoverable and non-recoverable rejects.
o Should include
o Date of destruction
o Name of product to be destroyed
o Type of destruction
o Place of destruction
o 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

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/over
view.pdf
o http://www.dot.ca.gov/hq/construc/stormwater/NS02Upda
te.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

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35. THANK YOU…
MBS