This document provides guidelines for waste disposal, scrap disposal procedures, and record keeping for a pharmaceutical company. It discusses responsibilities, definitions, regulatory bodies, types of waste, methods of product and waste disposal, procedures, scales of disposal, guidelines, and required records. The types of waste include hazardous, biomedical, radioactive, and different categories defined by WHO. Methods of disposal include incineration, immobilization, discharge to sewer, and chemical decomposition. Strict procedures and record keeping are mandated by regulations.

1. WASTE DISPOSAL, SCRAP
DISPOSAL PROCEDURES
AND RECORDS
GUIDED BY : Presented by :
Mr.Rajesh Parmar Mehta Pratik S.
M.Pharm Sem-1
Roll no: 5
DEPARTMENT OF QUALITY ASSURANCE
APMC COLLEGE OF PHARMACEUTICAL EDUCATION & RESEACH,
HIMMATNAGAR

2. Points to be covered:
RESPONSIBILITY
DEFINATION
REGULATORY BODIES THAT OVERSEE
PHARMACEUTICAL WASTE MANAGEMENT
TYPE OF WASTE
METHODS OF PRODUCT DISPOSAL
WASTE PRODUCT DISPOSAL PROCEDURE
SCALES OF PRODUCT DISPOSAL
PHARMACEUTICAL WASTE MANAGEMENT
GUIDELINES
RECORDS.
REFFERENCE

3. RESPONSIBILITY :
The responsibility may depend on the
following of the peoples in the Pharma
industry
Employees in production unit.
Representative of QA.
Housekeeping staff.

4.  DEFINATIONS
(1)Scrap: Materials like rejected foils, bottles,
cans, and tins etc. which have a resale value.
• Generated at various stages of manufacturing
1)During compression encapsulation coating &
packing stages.
2)In-process check.
3)Rejected printing packing materials.
4) From floor sweeping

5. 5) Expired or damaged goods.
6) Excess sample in QC after test.
7) Product sample from R&D at development
stage.
(2)Trash: This material is to be discarded or
disposed by suitable means and don’t have a
resale value. E.g. dust, unsalable materials

6. (3)Pharmaceutical Waste
Pharmaceutical waste is potentially
generated thorough a wide variety of activities
health care facility
general compounding
partially used vials
syringes, and IV preparation
discontinued & unused preparations
unused unit dose repacks
patients personal medications and
outdated pharmaceuticals

7.  Regulatory Bodies that Oversee
Pharmaceutical Waste Management
 Environmental Protection Agency (EPA)
 Department of Transportation (DOT)
 Drug Enforcement Administration (DEA)
 Occupational Safety and Health Administration
(OSHA)
 State Environmental Agencies,
 State Pharmacy Boards, and
 Local Publicly Owned Treatment Works (POTW)

8. Types of wastes
A) On the Bases of State
1. Solid
2. Liquid
3. Gaseous
B) On the Base of Effect
1) Hazardous Waste
2) Bio hazardous Waste
3) Radioactive Hazardous Waste
C) WHO categories of health care waste

9. 1) Hazardous Waste
A type of solid wastes that contain substantial or
potential threats to public health or the environment.
Must meet any of the following criteria:
– Specifically listed as a hazardous waste by EPA
– Exhibits one or more of the characteristics of
hazardous wastes (ignitability, corrosiveness,
reactivity, and/or toxicity)
– Is generated by the treatment of hazardous waste.

10. Storage Requirements:
1)Containers must be in good condition
2)Containers must be compatible with waste
3)Containers must be handled in a manner to prevent
leaks and spills
4) Containers must be inspected
5) Containers must be labeled “Hazardous Waste ”and
/ or list the contents of the container

11. Characteristic of Hazardous wastes
Characteristic wastes are regulated because
they exhibit certain hazardous properties –
1. Ignitability,
2. Corrosivity,
3. Reactivity and
4. Toxicity.

12. 1. Ignitability:
The objective of the ignitability
characteristic is to identify wastes that either
present a fire hazard under routine storage,
disposal, and transportation or are capable of
exacerbating a fire.
There are several ways that a drug formulation
can exhibit the ignitability characteristic

13. Types of Ignitability with Formulations
Ignitable Properties Formulations
1) Aqueous drug formulation a)Erythromycin Gel 2%
containing 24% or more b)Taxol Injection
alcohol and having a
flashpoint of less than 140 º F
or 60 º C.
2)Liquid drug formulations, a)Flexible collodion used
other than aqueous solutions as a base in wart removers
containing less than 24 %
alcohol, with a flashpoint of
less than 140 º F or 60 ºc.

14. Types of Ignitability with Formulations
Ignitable Properties Formulations
3) Oxidizers or materials a)Amyl nitrite inhalers,
that readily supply oxygen used for the rapid relief of
to a reaction in the absence angina pain
of air. b)Bulk chemicals found in
the compounding section
of the pharmacy such as
potassium permanganate

15. 2. Corrosivity:
Any waste which has a pH of less than or
equal to 2 (highly acidic) or greater than or
equal to12.5 (highly basic) exhibits the
characteristic of corrosivity and must be
managed as a hazardous waste.
Generation of corrosive pharmaceutical wastes
is generally limited to compounding chemicals
in the pharmacy. Compounding chemicals
include strong acids, such as glacial acetic acid
and strong bases, such as sodium hydroxide.

16. 3. Reactivity:
Reactive wastes are unstable under "normal"
conditions.
They can cause explosions, toxic fumes,
gases, or vapors when heated, compressed, or
mixed with water.
Nitroglycerin is the only drug that is
potentially reactive.

17. 4. Toxicity:
Wastes that exceed these concentrations must
be managed as hazardous waste.
The test that determines the ability of these
chemicals and heavy metals to leach in a landfill
environment is called the Toxicity Characteristic
Leaching Procedure, or TCLP.
If the concentration determined by the TCLP
exceeds the stated limits, the waste must be
managed as hazardous waste.

18. 2) Bio hazardous Waste
A solid waste that contains or may reasonably be
expected to contain pathogens of sufficient
virulence and quantity that exposure to the waste
by a susceptible host could result in an infectious
disease.
This waste includes such materials as used sharps
(needles, syringes, blades, pipettes, broken glass,
and blood vials), body fluids or materials mixed
with body fluids, bandages, or other materials
that have come in contact with body fluids

19. • Storage Requirements:
Containers must be clearly labeled with the
international biohazard sign and one of the
following: "INFECTIOUS WASTE",
"BIOMEDICAL WASTE", or "BIOHAZARD“
Sharps must be stored in rigid plastic
containers. Other wastes may be stored in
plastic bags or rigid containers.
labeled with a warning sign consisting of the
international biohazard sign
INFECTIOUS WASTE STORAGE AREA
UNAUTHORIZED PERSONS KEEP OUT”

20. 3. Radioactive Waste
1) High-level nuclear waste:
Means spent reactor fuel assemblies,
dismantled nuclear reactor components, and
solid and liquid wastes from fuel reprocessing
and defense-related wastes
Does not include medical or institutional
wastes, naturally-occurring radioactive
materials.

21. 2) Low-level radioactive waste:
Means waste material which contains
radioactive nuclides emitting primarily beta or
gamma radiation, or both, in concentrations or
quantities which exceed applicable federal or
state standards forum restricted release.
Does not include waste containing more than
100 Nano curies of transuranic contaminants
per gram of material.

22. WHO categories of health care waste
HealthCare waste Examples
1)Communal waste (solid Cardboard boxes, paper, food
wastes that are not infectious, waste, plastic and glass bottles
chemical, or radioactive)
2)Biomedical wastes Cultures, tissues, dressings,
Infectious waste (wastes swabs, and other blood soaked
suspected of Containing items; waste from isolation
pathogen) wards.
3)Anatomical waste Recognizable body parts.
4)Sharps Needles, scalpels, knives,
blades, broken glass.

23. HealthCare waste Examples
5)Pharmaceutical waste Expired or no longer needed
medicines or Pharmaceuticals.
6)Genotoxic waste Wastes containing genotoxic
drugs and chemicals (used in
cancer therapy
7)Chemical waste Laboratory reagents, film
developer, solvents, expired or
no longer needed disinfectants,
and organic chemical wastes.
(example, formaldehyde, phenol-
based cleaning solutions)

24. HealthCare waste Examples
8)Pressurized containers Aerosols
9)Radioactive waste Unused liquids from
radiotherapy; waste materials
from patients treated or tested
with unsealed radionuclide

25. OBJECTIVE OF PHARMACEUTICAL WASTE
TREATMENT
destruction or recovery for reuse and/or the
conversion of these substance to harmless
form that are acceptable for uncontrolled
disposal

26. METHODS OF PRODUCT DISPOSAL
1. High Temperature Incineration
2. Waste Immobilization: Encapsulation
3. Waste Immobilization: Inertization
4. Discharge to Sewer
5. Landfill Deposit
6. Chemical Decomposition
7. Medium Temperature Incineration
8. Open Container Incineration

27. 1. High Temperature Incineration
Incineration is a high temperature dry oxidation
process that reduces organic and combustible
waste to inorganic, incombustible matter and
results in a very significant reduction of waste
volume and weight.
Incinerators designed especially for treatment of
healthcare waste should operate at temperatures
between 900 and 1200 C and be equipped with
mechanisms to remove toxic byproducts.
 e.g. Pyrolytic incinerators, and municipal
incinerators by product removal mechanisms.

28. 2. Waste Immobilization: Encapsulation
Encapsulation involves immobilizing
pharmaceuticals in a solid block within a plastic or
steel drum.
Drums should be cleaned prior to use and should not
have contained explosive or hazardous materials
previously.
They are filled to 75% capacity with solid and
semisolid pharmaceuticals. The remaining space is
filled with cement, lime, plastic. The drums are
sealed, placed at the base of a landfill and covered.

29. 3. Waste Immobilization: Inertization
Inertization is a variant of encapsulation and
involves removing the packaging materials,
paper, cardboard and plastic from
pharmaceutical products.
Pharmaceutical products are ground and a
mix of water (5%), cement (15%) and lime
(15%) is added to form a homogenous paste.
The paste is transported by a concrete mixer
truck to a landfill and decanted into the normal
urban waste.

30. 4. Discharge to Sewer
Some liquid pharmaceuticals can be diluted
with water and flushed into the sewers in small
quantities without serious public health or
environmental affect.
5. Landfill Deposit
To landfill means to place waste directly
into a land disposal site without prior
treatment or preparation

31. 6. Chemical Decomposition
Chemical inactivation is tedious and time
consuming. If done, stocks of the chemicals used
in the treatment must be available at all times.
This method may be practical for disposal of a
small quantity of anti-neo-plastics drugs
7. Medium Temperature Incineration
Temperature ranges between 300-400°C.
Used only in the absence of high temperature
incinerators.

32. 8. Open Container Incineration
Open-air burning should take place in the pit of final
disposal where these solids will be put
underground. Processes must be closely supervised
by the person responsible for waste management in
the heath care facility.
The area within which the burning is carried out
should be fenced off to prevent animals and
unauthorized persons from entering.
Burning is generally incomplete, non-uniform and
produces large quantities of toxic pollutants.so
Restrict use to emergency situations only

33.  WASTE PRODUCT DISPOSAL
PROCEDURE
1) Product disposal:
Any product requiring disposal should initially be
separated from its packaging if appropriate. For
example, any product to be disposed in an approved
landfill site should not be left in impermeable glass,
plastic, or other containers which would
significantly delay destruction.
Ideally, INCINERATION procedures have
preference over LANDFILL ,where incineration is
used, product in plastic or other flammable
packaging may not need.

34. 2) Printed packaging disposal:
The disposals of printed packaging components
include labels, inserts, and cartons possess no health
risk.
However, ineffective disposal, such as in the public
landfill, can give rise to public concern that product
may be associated with the packaging. Such
materials should preferably be incinerated.

35. 3) General trash and savage:
Normal local services will be adequate for sewage
and trash. However internal procedures should be
sufficiently rigorous and monitored, to ensure that
product and the packaging waste does not get
intermixed.
Containers used within the plant to accumulate
waste materials should be clearly marked to denote
their designated use.
CFR (Code of federal regulation) 211.50 states that
“Sewage, trash and other refuse in and from the
building and immediate premises shall be disposed
of in a safe and sanitary manner

36. Ten Steps:
1. Identifying drugs that must be managed as hazardous
waste.
2. Determining which non-regulated drugs will be managed
as hazardous waste.
3. Labeling drugs to facilitate segregation of hazardous
waste.
4. Preparing and maintaining hazardous waste manifests.
5. Determining their hazardous waste generation status and
what criteria are used for hazardous waste selection.
6. Scheduling regular program reviews.
7. Keeping management informed.
8. Plan for Emergencies
9. Train the Employees
10. Keep Records

37. SCALES OF PRODUCT DISPOSAL
Large-scale Destruction
Medium-scale Destruction
Small-scale Destruction

38. PHARMACEUTICAL WASTE MANAGEMENT
GUIDELINES
 This Blueprint focuses primarily on three
aspects of pharmaceutical waste
management:
1) Management of regulated hazardous
pharmaceutical waste.
2) Management of non-regulated hazardous
pharmaceutical waste.
3) Minimization of pharmaceutical waste.

39. Schedule M of Drug and Cosmetics Act,
gives guidelines in this regard:
1)”The disposal of sewage and effluent from
manufacturing shall be in conformity with
requirement of environmental pollution
control Board”
2)All biomedical waste shall be destroyed as
per provision of bio-medical waste
(Manufacturing and Handling) Rules, 1996.
3)Additional precaution shall be taken for
storage and disposal of rejected drugs.
Records shall be maintained for all disposal
of waste.

40. 4)Provision shall be made for proper and safe
storage of waste materials, awaiting disposal.
• Hazardous toxic substance and flammable
materials shall be stored in suitably designed
and segregated enclosed areas in conformity
with central and state legislation.
5)The material is generally sold to scrap dealers.
Precautions should be taken before selling
these materials to scrap dealer

41. e.g.; 1) Empty solvent containers should be free
from residual solvent lying at bottom of
drums.
2) Rejected printed packaging materials
(Labels, cartons, foils, etc) should be
defaced, destroyed before sending to scrap for
storage and sale.

42. WHO guidelines:
I. Provision should be made for proper and safe
storage of waste materials awaiting disposal.
Toxic substance and flammable materials
should be stored in suitably designed, separate,
enclosed cupboards as required national
legislation.
II. Waste materials should not allowed to
accumulate. It should be collected in suitable
receptacles for removal to collection points
outsides the building & disposed off safely & in
a sanitary manner at regular & frequent interval.

43. RECORDS:
Keep it for at Least 3 Years for followings
o License applications (if applicable)
o Licenses (if applicable)
o Land Disposal Restriction forms
o Inspection logs
o Recycled waste shipping papers
o Emergency Response record
Records: Keep Longer
o Analytical Reports
o All data used in evaluation
o Training documents

44.  Records: Access
o Copy must be maintained at generator site
o Must be available for inspection
o Paper or Electronic
 Date of destruction, name of the product to be
destroyed, type of destruction, place of destruction,
cause of destruction should be included in the relevant
record.
 Quantities rejected and destroyed must be recorded
and reconciled in relevant batch documents.
 Safety precautions taken while carrying out destruction
must be included in the records.
 Signature of the supernatants after completion of the
destruction in records

45. REFERENCE:
1)Willing HS, Stoker RJ, ”Good Manufacturing
Practices For Pharmaceuticals” Fourth Edition, p.
47-48.
2)Potdar AM,”Pharmaceutical Quality Assurance”
Nirali Prakashan, First Edition, p.7-8.
3)Sharma PP.”How to Practice GMPs”, Vandana
Publication, Third Edition, p. 634.