a detailed study on complaints, drug recall, returned goods and waste disposal is studied here in the presentation for the students of sixthe semester b.pharm following the PCI syllabus.

1. COMPLAINTS, RECALLED
GOODS, RETURNED
GOODS, AND WASTE
DISPOSAL
Ms. TENY SARA THOMAS
MOUNT ZION COLLEGE OF PHARMACEUTICAL
SCIENCES AND RESEARCH, ADOOR, KERALA
ASSISTANT PROFESSOR
B.PHARM SIXTH SEMESTER
PHARMACEUTICAL QUALITY ASSURANCE
UNIT IV – CHAPT1

3. COMPLAINTS
 Despite all the precautions taken, some
problems may occur in a given drug
product.
 The customer finds the faults in the
product.
 And the dissatisfaction is conveyed in the
form of a COMPLAINT.
 Complaints are then investigated and
corrective actions are taken.

4. DEFINITION
 Complaint is defined as statement that is
something wrong or not good enough,
which shows customer dissatisfaction
about the company and the product.
 Example: complaining about the drug
product or the packaging materials etc.
 All complaints concerning defective
products should be carefully reviewed
according to written procedures.

5. NEED FOR COMPLAINT HANDLING
 Gives the company an opportunity to improve
the quality of the product.
 Helpful to maintain cGMP.
 Maintains committed relationship between the
customer and company.
 Reduce costs and improve production
schedules.
 Reduce employee confusion.
 Improve safety and performance of devices.

6. CLASSIFICATION OF COMPLAINTS
A. CRITICAL COMPLAINTS
 Individual defects which can be critical and require the
company to take in need of attention action by all
reasonable resources, whether in and out of company
hours.
Example: microbial contamination of a sterile product.
B. MAJOR COMPLAINTS
 These complaints will possibly put the patient at a little
hazard but are not life threatening and will require
product recall within a few days.
example: any labelling/leaflet misinformation.
C. MINOR DEFECTS
 Complaints which present only a significant risk to patient.
Example: readily visible inaccessible packaging/closure faults.

7. STEPS TO HANDLE COMPLAINTS
Good Complaint Handling Procedure are
implemented by steps which are divide into
four.
1. Receiving Complaints
2. Technical Investigation
3. Corrective and Preventive Actions(CAPA)
/ Feedback to Customers.
4. Trend Analysis / Monthly Reports

8. RECEIVING COMPLAINTS
 Complaints must provide open channels
through which customers can arise their
complaints
 The company must appoint a person who
will be responsible for receiving the
complaint, and documenting it as per
company requirements.
 The most flexible channels are toll-free
numbers and chat-rooms.

9. CUSTOMER
COMPANY’s
CONTACT
PERSON
QUALITY
COMPLAINT
OFFICER
Make complaint
through toll free
no. , e-mails, chat
room
• Open the
investigation,
including
information, about
the customer and
about the complaint
• ask the customer
to return the
product for analysis
STEP 1

10. TECHNICAL INVESTIGATION
Once the complaint has been received, a
complaint investigation form should be
prepared with the following information:-
 Name and contact details of complainant.
 Details of the drug product on which
complaint has been raised – product name,
manufacturing batch number, lot number,
manufacture and expiry dates, quantity of
product where problem is seen
 Details of the nature of complaint – what
exactly is wrong and has been complained
about.

11. Product complaint data sheet details include:-
 Serial number of complaint
 Complaint details
 Name and address of the complainant.
 Date of receiving the complaint
 Name of the person who received the complaint.
 Details of the product – name, strength, batch number
 Size of sample obtained from the complainant.
 Complaint evaluation report.
 Name and sign of the investigators with date.
 Action taken report
 Copy of written response sent to complainant.

12.  All this information is sent to the Quality
Assurance department to start investigation. A
QA officer is appointed as Complaint Officer
to oversee the next stages.
 Two phases of investigation will follow:-
1. Document Based investigation
2. Laboratory Analysis

13. DOCUMENT BASED INVESTIGATION
This involves review of :-
 Complaint files to see how many previous
complaints of a similar nature have occurred,
and how the complaints were handled.
 Batch manufacturing and packaging records
to check for any incidents of non-
conformance during that particular batch’s
processing.

14. LABORATORYANALYSIS
 This phase involves analysis by the Quality
Control laboratory. The samples received
with the complaint as well as the samples
that have been retained by the manufacturer
must be tested and the results are
documented.
The Complaint Officer compares the results of
the laboratory analysis and the document
based investigation and prepares a report that
may result in one of the conclusions:-
• Confirmed complaint
• Non – Confirmed complaint
• Counterfeit/ Tamper Suspicion

15.  Confirmed Complaint – when out of specification
(OOS) results are seen in both complaint and
retained or in only complaint samples. For e.g. if
both samples of tablets showed discolouration, o
one tablet is missing from blister pack.
 Non Confirmed Complaint – when both retained
and complaint samples test results comply with
specifications, or if complaint samples show OOS
results. For e.g. tablets in complaint sample are
discoloured but not in retained samples.
 Counterfeit/ tamper suspicion – when retained
sample meets specifications but complaint
samples are OOS, with no possible reason to
explain the deviation. For e.g. if packing material
of complaint sample is different from the retained
– counterfeit drug. Or if colour of complaint
sample is totally different from retained –
tampered drug.

16. The Complaint Officer investigates if the
complaint involves any unexpected or
serious adverse drug reaction.
After complaint of investigation,
generally within 30 days of receiving the
complaint, the report is prepared and
signed by Complaint Officer and QA
manager.
the complaint file must be maintained for
at least 1 year following the expiry date
of the productive batch.

17. QA
COMPLAINT
OFFICER
Quality Assurance
department to start
investigation. The
Complaint Officer
investigates if the complaint
involves any unexpected or
serious adverse drug
reaction.
STEP 2
1.DOCUMENT
BASED
INVESTIGATION
2.LABORATORY
ANALYSIS
COUNTERFEIT/
TAMPER SUSPICION
NONCONFIRMED
COMPLAINT
CONFIRMED
COMPLAINT

18. CORRECTIVE & PREVENTIVE ACTIONS/
FEEDBACK TO CUSTOMER
 In case of confirmed complaints, company
must implement corrective actions depending
on the severity of the problem.
A team of representatives from Production, QC,
QA and higher management areas is put
together for launching CAPA
 In case of non confirmed complaints, that
may have originated from improper handling ,
company sends a written response to the
complainant, including information on the
corrective method adopted. Also a free
replacement is sent to the customer.
 In case of therapeutic complaints or ADR,
the company may decide for a product recall, if
they see a risk in sale of drug.

19. CORRECTIVE ACTION
•Depend on nature of complaint
•Training
•CAPA procedures
•Product recall
STEP 3
FEEDBACK TO THE CUSTOMER
•Explanation letter to customer about the results
and reason.
•Delivery of free product as reimbursement.

20. TREND ANALYSIS/MONTHLY
REPORTS
 Monthly reports should be elaborated in order
to evaluate the amount and the nature of
complaints received and to perform a trend
analysis of these complaints.
 The monthly report must answer the
following:-
◦ How many complaints did the company
receive in the period?
◦ How many were confirmed, nonconfirmed
or counterfeit/tamper suspicion?

21.  Graphic methods of displaying data are
important adjuncts to data analysis and
presentation.
 The report must be readily available mainly
during GMP inspections.
STEP 4
TREND ANALYSIS
•Number of reports :- category, nature, segment,
batches
•Identification and implementation of corrective
actions.
•Sharing of report with all departments.

22. DOCUMENTATION OF FINAL REPORT
ONCOMPLAINTS
 Nature of the complaint:- ____________
 Date:- __________
 Complaint:- _________________
 Originator of the complaint& title:-
_____________
 Distributor contact person & title:- __________
 Method of notification:- ______________
 Name:- ____________
 Phone No:-________ P.O - ______
 Date shipped:- __________ Invoice:-
_______
 Product name:-__________ Control No.:-
____
 Expiry date:__________ Quantity
involved:-____

23.  Total quantity shipped- ________
 Reason for complaint return request-
_________
 Evaluation of complaints: -
physical characteristics
sign of deterioration
other observation
 Quality control findings:-
returned sample
returned sample re assay
initial data
quality control comments &
suggestions
 Packaging or labelling or inserts
evaluation.

24. Resultant action taken:
1. Method, date of customer notification &
authorized:- _________
2. Comments:- ___________
3. Completion date for action taken:-
___________
4. Quality assurance evaluation:-_____________
CUSTOMER COMPLAINT RECORD BOOK
REPORT
NO.
DATE
RECEIVED
PRODUCT
NAME
RECEIVED
BY
PRODUCT
LOT NO.
DATE
INVESTIG
ATION
STARTED
DATE
INVESTIG
ATION
ENDED

25. REGULATORY GUIDELINES
 A SOP should be available giving full details about
how to handle products complaints and necessary
records about complaints should be maintained.
 A person should be designated for handling the
complaints and deciding the measures to be taken
 Person should be normally be from quality
management department.
 All decisions and measures taken as a result of a
complaint should be recorded
 If product defect is suspected in a batch, other
batches should also be checked in order to
determine whether they are also affected.
 Written records shall be maintained for at least 1
year after the date that the complain was received.

27. WHAT IS DRUG RECALL?
A process for withdrawing or removing a
pharmaceutical product from the pharmaceutical
distribution chain because of defects in the
product, complaints of serious adverse reactions to
the product or concerns that the product is
counterfeit. The recall might be initiated by the
manufacturer, wholesale dealer license holder or
the Department of Health.

28. OBJECTIVES OF A DRUG
RECALL
 To stop the distribution and sale of the
affected product.
 Effectively notify management, customers
and regulatory authority.
 Efficiently remove the affected product
from the market place, warehouse or
distribution areas.
 Dispose and conduct a root cause analysis
and report the effectiveness and outcome of
the recall.
 Implement a corrective action plan to
prevent another recall.

29. According to Central Drugs Standard
Control Organisation (CDSCO),
quality defects may include,
 Drugs of not standard quality
 Spurious or adulterated drugs
 Drugs manufactured under cancelled
or suspended license.
 Drugs manufactured despite being
prohibited under the provisions of the
Drugs & Cosmetics Act

30. REASONS FOR DRUG RECALL
 Potentially dangerous or serious product quality
issues have come to light through complaints.
 Mandatory regulations have been violated and
come to the notice of regulatory agency.
 Labelling errors and incorrect outer packing.
 Lack of assurance of sterility and drug stability.
 Misbranded drug
 Lack of efficacy, failing dissolution test
requirements, microbial contamination in
products
 New information comes into light after
distribution of product indicates it is unsafe or
ineffective or dangerous.5

31. CLASSIFICATION OF DRUG
RECALL
The CDSCO classifies Recalls into three categories:-
CLASS I – is the situation in which there is
reasonable probability that the use of a defective
product will cause serious adverse health
consequences or death.
 Recalls under this class must be executed to the
level of distributor/wholesaler, retailer and
consumer.
 Public announcements shall be made using print and
electronic media
 Timeline for recall ranges from within 24-72hours
 Stopping the sales or distribution must be done
within – 24hours
 Physical recall must be completed within – 72hours.
 E.g. – wrong active ingredient, wrong strength.

32. CLASS II – is the situation in which use of
defective product may cause temporary adverse
health consequences
 Probability of serious ADR is remote.
 Recall is limited at level of distributor/
wholesaler.
 Time limit for recall is within – 10 days. E.g.-
mislabelling.
CLASS III – is the situation in which the use of
defective product is not likely to cause any
adverse health consequences.
 Recall is executed until the wholesaler level.
 Time limit – 30days. E.g. – faulty closure,
wrong expiry date.
Banned drugs for which license is cancelled or
suspended, if found to be in the market, shall
have to be recalled, - being treated as CLASS
I

33. TYPES OF DRUG RECALL
Product recall may be of two types:-
A) Voluntary Recall
 refers to situations when manufacturer
decides on their own initiative to recall
products where the safety, efficacy and
quality of batch is in question
 E.g 1. – an in-house reveals a failure that
can cause adverse effect on the quality of
a batch of products that has been
distributed.
 E.g 2. – market complaints investigation
show that the entire batch is defective.
 E.g 3. – visual inspection of retained show
evidence of deterioration that has an
impact on product quality.

34. B) Statutory Recall
 refers to recalls mandated by drug
regulatory bodies at Central or State
levels for one of the reasons
 E.g 1. – product violates the law – not
of standard quality.
 E.g 2. – formulation contains banned
drugs.
 E.g 3. – labelling of product or
promotional material violates the law.
 E.g 4. – product claims to treat diseases
mentioned in Schedule J (claims to
cure a disease that no drug can)

35. PRODUCT RECALL SYSTEM
 Every company is required to have a product
recall system in place to effect a prompt and
effective recall in case of serious complaints
regarding defective products.
 As per cGMP guidelines, product recall
activities must be coordinated and executed by
an authorized person who is independent of the
marketing and sales function of the company.
 The recall approving authority is generally the
Head of the Company
(President/Proprietor/Managing Director).
 Recall strategy must be prepared which is a
planned specific course of action to be taken in
conducting a specific recall.

36. Recall strategy details must include information
regarding:
 Authorized person who will initiate the recall.
 Nature of communication that will be used to
initiate recall (telephone, email, letters etc.).
 Depth of the recall to be instituted (recall from
distributor/wholesaler/hospital/ retailer/general
public).
 Manner of receiving, segregating and secure storage
of the recalled product.
 Satisfying reports to be prepared, at what
frequency.
 Verification of success of recall and report
submission to regulatory authorities.
 Steps to be taken to avoid re-occurrence of the
same issue with the product.
 Dealing with recalled product – reworking or
destruction as may be appropriate

37. PRODUCT RECALL TEAM
 A recall coordinator is to be appointed and
members of a recall team identified from
the various functional areas.
 All members must ensure that all
procedures are carried out effectively and
efficiently. The team should receive
appropriate training.
 Recall management team list shall be
updated at least four times a year.
 Chief executive officer – decision making,
media communication.
 Quality assurance manager – quality or
technical advisory, complaint investigation

38. PRODUCT RECALL
PROCEDURE
 For potentially violative product that
may lead to a Class I or II recall, an
inspection should be made to determine
the root causes of the problems.
 The suspected problem is discussed
with the management and reviewed.
 Review batch records, or other types of
records for violative lots.
 Determine what actions the firm has
taken or plans to take.

39. If the firm has decided to recall,
 Management should obtain the FDA’s
district review of recall and any press
releases before they are issued to prevent
misunderstandings between the firm, its
customers, and FDA.
 Obtain an official sample of the recalled
product, a complete distribution list of all
shipments of the suspect lot, specimens pr
copies of all labels.
 Obtain complete copies of all recall
communications issued or planned
including phone or text conversations, and
submit them to districts recall coordinator.

40. STAGES OF PRODUCT RECALL
1. Recall alert
2. Recommendation for recall number
3. Recall product
4. Code
5. Recalling firm/ manufacturer
6. Reasons for recall
7. Volume of product in commerce
8. Distribution pattern
9. Firms recall strategy
10. Firm official
11. Audit program
12. Monitoring recalls
13. Termination of recall
14. Close out inspection

41. 1. Recall alert:- a 24hour alert is given for
the product recall.
2. Recommendation for recall number - a
memorandum should be prepared as soon
as the recall number is available
3. Recall product – its name, type, strength,
size, form, route of administration, brief
description of the product whether it is
OTC or prescription based.
4. Code – list of all lot/serial number,
product number, manufacturer number
which appears on the product label.
5. Recalling firm – provide complete name
& address of the recalling firm & identify
the type of firm i.e., manufacturer,
importer, etc.

42. 6. Reasons for recall – a detailed information
based on the analytical findings in
qualitative or quantitative terms,
inspectional evidences, or complaints,
injuries that prove the product is defective.
7. Volume of Product in Commerce – total
product distributed at all levels.
8. Distribution pattern – report the areas of
distribution of products to the local areas
of all levels, foreign countries,
government military agencies.
9. Firms recall strategy – describes the
firm’s planned recall strategy. Includes the
date of initiation of recall.

43. 10. Firm Official – report the name, title,
location, and telephone number of the firm
official to be contacted concerning the
recall.
11. Audit program – report appropriate
action taken & also provide details of any
publicity issued or planned by the firm,
state or local govt.
12. Monitoring recalls –
a. Re-inspect the firm between and
termination of recall to monitor its
progress
b. A recall audit check is a personal visit or
phone call to consignee from a recalling
firm in the chain of distribution.

44. c. Conducting the check –
 Details of the recall
 Recall strategy
 Amount of product recalled till date
 Visit storage sites of the recalled product,
check shelf stock to ensure all recalled
product has been identified, removed from
areas and properly quarantined.
 If injury or complaint is reported, furnish
the corrective actions taken
 Amount of product destroyed, and method
of destruction.
d. Reporting of the audit checking.

45. 13. Termination of recall - a recall will be
terminated if efforts have been made to
remove or correct the violative product in
accordance with the recall strategy.
Written notification that a recall is
terminated will be issued by the authority
to the recalling firm.
14. Close out inspection – a limited
inspection made to verify the termination
of recall by the recalling firm. During the
closeout inspection, witness destruction or
reconditioning of the recalled product is
done.
If unable to witness the destruction, a
written documentation from firm should
be obtained.

48. Pharmaceutical products may be returned from
the market in case they do not meet their
acceptance criteria or any other various reasons.
E.g. quality problems, accidental damage of
goods. Such products when returned from the
market should have the following actions
immediately taken.
 Physically examine the condition of the
returned goods and the relevant documents.
 Ask quality control department to evaluate the
quality of the goods received, and take a
decision on whether these products can be
reprocessed and recovered or needs to be
destroyed.

49.  If it is possible to reprocess and recover, then
such products after reprocessing and retesting
may be considered for relabeling, repacking
and resealing.
 Quality control department should evaluate
all aspects like condition of the received
material, time elapsed since it was first
processed along with microbiological or any
other technical evaluations.
 Any action taken should be recorded.

50. For each return of a product, documentation
should include:-
 name and address of the consignee
 Intermediate or API
 Batch number
 Quantity returned
 Reason for return
 Use or disposal of the returned product

51. STANDARD OPERATING PROCEDURE
OF HANDLING RETURNED GOODS
 Returned goods shall be received, identified and
stored in the designated area by the warehouse
person with the identification label as “Returned
Goods”.
 Warehouse person shall check dispatch
documents and documents received from the
distributor / customer inspect the consignment
and shall record the observation in Returned
Goods verification report. Now this report shall
be sent to Quality assurance department.

52.  Quality assurance personnel shall verify the
returned consignment.
 If the seal is broken by the customer, the
material shall be sampled from each container
and analysed.
 Based on satisfactory evaluation against
specification, decision of release shall be taken
and material can be sent for re-sale.
 If results are border line / out of specification
limit then material shall be rejected and
investigation shall be carried out.

53.  In case the material is about to expire, then the same
shall be analysed for the identification and shall be
taken for the appropriate reprocessing.
 If the material is found to be contaminated, then it
shall be sent for destruction or disposal.
 Based on the findings and analytical results of
returned goods, Quality Control department shall
recommend for – reprocessing, repacking,
distribution for sale, or destruction.
 This is also informed to the Warehouse for the
further action.
 QC department shall maintain record for returned
goods along with its complete set of documents.

54. Sales return no. ___________________
Product name ___________________
Batch no ___________________
Date of return ___________________
Net wt. ___________________
Content No. ___________________
LABELLING OF RETURNED
GOODS

56. Waste includes all items that people no longer have
any use for, which they either intend to get rid of
or have already discarded.
Pharmaceutical waste potentially generated
includes:-
 Expired drugs
 Patients discarded personal medications
 Contaminated garments, absorbents
 Syringes, vials, iv bags, tubings
 Waste materials containing chemotherapy drug
residues.
 Open containers of drugs that cannot be used.

57. TYPES
OF
WASTE
HAZARDOUS
NON -
HAZARDOUS
CHEMO WASTE
BIOHAZARDOUS
INERT
WASTE
RADIOHAZARDOUS

58. A) HAZARDOUS WASTE
 Potentially dangerous to human health or environment.
 Hazardous wastes can be of two types –
characteristic waste and listed waste.
 Characteristic waste – are waste which may have the
following characters :-
 Ignitability – identify waste that either present a fire
hazard under routine storage, disposal, and
transportation. E.g. Erthromycin gel.
 Corrosivity – any waste which has a pH of less than or
equal to 2 or greater than or equal to 12.5 exhibits the
characteristic of corrosivity. E.g. – glacial acetic acid
 Reactivity – waste which can cause explosion, toxic
fumes, gases when heated, compressed etc. E.g. –
nitroglycerine
 Toxicity – if the waste leaches in a landfill environment
and the determined level exceeds the stated limits

59.  Listed hazardous waste :- wastes from
common manufacturing and industrial process.
These can be of four type :- P, U, F & K.
Pharmaceuticals comes under the P and U list
 P list and U list wastes – are chemicals that are
acutely hazardous under Resource Conservation
and Recovery Act. . P listed waste are toxic and
cause death or irreversible illness at low dose.
U- listed waste are identified as toxic wastes.

60. B) NON - HAZARDOUS WASTE
 Presents significant hazardous characteristics.
 No hazardous components present.
 Pharmaceutically inert
C) BIOHAZARDOUS WASTE
 Contain pathogens of sufficient virulence and
quantity that exposure to the waste by a
susceptible host could result in an infectious
disease.
 Waste includes needles, syringes, pipettes, vials
that may have come in contact with body fluids.
 Container must be clearly labelled with
“biomedical”, “infectious waste”
 Stored in rigid plastic containers.

61. D) RADIOACTIVE WASTE
 High level nuclear waste – reactor fuel
assemblies, solid and liquid waste from fluid
reprocessing.
 Low level nuclear waste – that contains
radioactive nuclides emitting beta or gamma
radiation.
E) INERT WASTE
 Materials that do not have any therapeutic effect
but they are used for supportive nutrition. E.g.
sodium chloride solution.
 They may become mixed with other chemicals.
 Checked for hazardous properties before
disposal

62. F) CHEMO WASTE
 Classified as Trace Chemotherapy and Bulk
Chemotherapy
 Trace Chemotherapy Wastes include;-
1. gowns, gloves, wipes, associated with
routine handling, preparation and administration
of chemotherapy
2. wipes and other materials used during
cleaning and decontamination of a biological.
 Bulk Chemotherapy Waste – any
chemotherapy waste that is not deemed RCRA
empty.
E.g. any item used to clean up a chemo spill.

63. DISPOSAL
OF WASTE
INCINERATION
CHEMICAL
DISINFECTION
MICROWAVIN
G
AUTOCLAVING
SECURE
LAND
FILLING
DEEP
BURIAL
IMMOBILISATION
INERTIZATION
SEWER
TREATMENT

64. 1. INCINERATION
 Solid organic waste are incinerated or burnt
to convert them into gaseous products and
a solid residue in the form of ash
 Best ways to dispose hazardous wastes
 Suitable for highly reactive chemicals like
halogens.
 Ash produced after incineration must be
disposed into a secure landfill.
 Arrangements for preventing air pollution
from the gas produced during the process.

65. 2.WASTE IMMOBILISATION -
ENCAPSULATION
 Encapsulation involves immobilising
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 by spot welding, placed
at the base of a landfill and covered with fresh
solid waste.

66. 3.WASTE IMMOBILISATION -
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 concrete mixer
truck to a landfill and decanted into the
normal urban waste.

67. 4. CHEMICAL DISINFECTION
 Treating waste materials with chemicals
that will inactivate the chemicals or
biological materials present in the liquid
waste.
 Effectiveness of the process depends on the
type of chemical used, its concentration,
and nature of contact between disinfectant
material and waste.

68. 5. MICROWAVING
 Includes the use of microwave radiation
and can destroy the infectious materials in
the biological waste.
 Electricity requirement is less and steam is
not needed.
 Waste materials required to be shredded
prior to microwaving in order to allow the
radiation to come into contact with the
waste material.

69. 6. AUTOCLAVING
 Saturated steam is passed through the
waste in the autoclave for a duration and at
a temperature sufficient to destroy the
pathogens.
 Commonly used for biomedical waste
disposal and waste generated from the
microbiological testing laboratory.
 After autoclaving, the waste is disposed by
land filling.
 Not best for chemical and drug product
waste.

70. 7. DEEP BURIAL
 Waste is buried in deep pits that are at least 2
metres deep.
 One must ensure that the soil is impermeable
in these areas and that there are no shallow
wells in the area to avoid the risk of water
contamination.
 Half the pit is covered with the biomedical
waste and rest is filled with lime, stopping
50cm below ground surface.
 Final layer of the pit is made up of soil to
cover the waste.
 Such burial should be done in area not prone
to flooding.

71. 8. SECURE LAND FILLING
 Waste are disposed by burying in landfills
that has been designed to contain
hazardous wastes.
 If not properly designed and operated, the
landfill may lead to liquid leaching into the
ground water, attraction of vermin etc.
 Also gas extraction systems must be
available for the removal of carbon dioxide
and methane that has produced by the
anaerobic breakdown of the waste.

72. 9. SEWER TREATMENT
 Some liquid pharmaceuticals can be diluted
with water and flushed into the sewers in
small quantities without serious public
health or environmental affect.

73. WASTE MANAGEMENT
STRATEGY
 Waste Minimization
 Reuse
 Recycling
 Energy Recovery

74. WASTE MINIMIZATION
 Prevention of waste material from being created –
waste reduction.
 There are limitations of substituting hazardous
substances with lesser hazardous substances as the
hazardous substances are of more therapeutic effect.
 Priming and flushing IV lines with saline solution.
 Maximising the use of open chemotherapy vials.
 Replacing pre-packaged unit dose liquids with patient
specific oral syringes.
 Reuse of second hand products, repairing broken items,
designing products to be refillable or reusable.
 Develop a detailed organisation’s approach to
identifying drugs that must be managed as hazardous
waste.
 Training the staff about minimizing wastage.

75. REUSE
 Use of a product on more than one occasion, either for
same or different purpose.
 Avoids discarding a material to waste stream when its
initial use has concluded.
 E.g. returnable plastic pellets
 Using empty glass jar for storing items
 Using second hand clothes.
RECYCLING
 Involves treatment or reprocessing of a discarded waste
material to make it suitable for subsequent reuse either
for its original or for other purposes.
 Recycling benefits the environment by reducing the use
of virgin materials.
 In the European Union, 13% waste is recycled.

76. ENERGY RECOVERY
 Energy content of waste products can be harnessed
directly by using them as direct combustion fuel.
 Thermal treatment ranges from using waste as a fuel
source for boilers to generate steam and electricity.
 Waste materials are heated to high temperatures with
limited oxygen availability.

77. WHO GUIDELINES
 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.
 Waste materials should not be allowed to
accumulate. It should be collected in suitable
hollow object for removal from collection
points outside the building and disposed off
safely and in a sanitary manner at regular and
frequent interval.

78. WASTE PRODUCT DISPOSAL
PROCEDURE
1. Any product requiring disposal should initially be
separated from its packaging.
2. Identify drugs that must be managed as hazardous
waste.
3. Determining which non-regulated drugs will be
managed as hazardous waste.
4. Labelling drugs to facilitate segregation of
hazardous waste.
5. Preparing and maintaining hazardous waste
manifests.
6. Determining their hazardous waste generation
status and what criteria are used for hazardous
waste selection.
7. Scheduling regular program reviews and keeping
management informed.

79. RECORDS
Keep it for at least 3 years for following:-
 License applications
 Licenses
 Land disposal restriction forms
 Inspection logs
 Recycled waste shipping papers
 Emergency response record
 Analytical reports
 All data used in evaluations
 Training documents