SOP-QAU-007-02-Disposal of Unusable Pharmaceutical Products

PFSCM Knowledge Tree Official Copy
Standard Operating Procedure

F-QSU-002-002--01
Section: Number: Title: Revision:

QAU 007 Disposal of Unusable Pharmaceutical Products 02
Name Title Si nature* Date
Lead Author J. Craig

Principal Waste /JR
Management Advisor
Section/Unit Product Quality
C. Best
A roval Assurance Mana er
Freight Forwarding Global Inventory
C. Larson
and Lo istics Mana er
Add any additional
N/A
a rovals
QSU Approval: M. Harrigan QSU Manager
Management G. Comstock Deputy Director,
A roval: Global Su I Chain
Effective Date: o' f •z. (-z.c Review Period: Annual
SOP-QUAL-007-
Supersedes:
01
*Signature can be electronic or handwritten
1. Purpose
This SOP describes the procedures to be used for the disposal of unusable pharmaceutical products
in accordance with WHO "Good Distribution Practices" (GDP) and good environmental and public
health practices. The disposal of product includes technical issues managed through the Principal
Waste Management Advisor, financial issues managed through the Global Inventory Manager (GIM),
and contract issues managed through the Senior Contracts Officer. Any use of USG funding for
disposal including SCMS staff time must have the concurrence of the USAID, or applicable client,
obtained through the SCMS Contract Manager.
2.Scope
The scope of this SOP applies to all SCMS-supported activities to control and confirm the disposal of
unusable pharmaceutical products whether USG-owned in SCMS custody or assisting at the client's
request in the disposal of client-owned pharmaceuticals. This SOP may be adopted or adapted by the
host country or other clients to help ensure that safe health and environmental standards are
maintained for the disposal of their unusable pharmaceutical products provided the quality measures
are retained.
This document is uncontrolled when printed. For the official copy, please check the SCMS Intranet.
Page 1 of 9
Knowledge Tree Official Copy
PFSCM
F-QSU-002--002-01

3 . Respons1"bTti
11 es
Title Responsibility
On a routine basis, identifies and quarantines any USG-owned
pharmaceutical waste in SCMS custody. Creates pharmaceutical disposal
list. Requests authorization for disposal of pharmaceutical waste from
Procurement, USG, GIM, and Principal Waste Management Advisor, and
Responsible Pharmacist USAID concurrence through SCMS Contract's Officer. Arranges, in
orSCMS coordination with local and national regulatory authorities, for the removal
designee/Regional of pharmaceutical waste and arranges for the disposal with an appropriate
Distribution Center contractor. The USG representative and SCMS designee witness and
Manager or FFL document the disposal. Retains copies of pharmaceutical disposal list,
disposal authorizations, disposal certificate, and receipt for disposal
services. Files all documents in SCMS Knowledge Tree (KT) archive in
the Quality Assurance/Waste Management Folder under Hazardous
Waste in the named country file.
Reviews disposal inventory, proposed disposal methods, local and
Principal Waste national regulatory authority concurrences, and issues approval for the
Management Advisor disposal protocol. Notifies Contracts Manager when all required
documents are posted on SCMS KT.
Authorizes disposal of USG-owned product in SCMS custody and
forwards lists to the Senior Contracts Officer and Contracts Manager to
Global Inventory resolve liability/insurance options and obtain USAID concurrence when
Manager (GIM) applicable GIM periodically reviews recordkeeping during site visits to
ensure that it is maintained.
Provides GIM with the original destruction certificate with a copy to the
Assistant FFL
Principal Waste Management Advisor, in situations in which the waste is
Operations Coordinator an SCMS- provided product.
Reviews Retention Store analytical sample expiry date reports at least
Quality Control (QC) quarterly. Schedules disposal of products at least one month past expiry
Specialist dates.
For USG-owned products in SCMS custody which are unusable, reviews
Senior Contracts Officer causes of damage to determine possible vendor or shipper liability for
SCMS insurance claims.
For USG goods in SCMS custody and expenditure of SCMS funds for
Contracts Manager disposal, obtains concurrence for disposal.
4. Definitions
Term Definition
Defined as such by the pharmaceutical regulatory authority, a substance
Controlled substance which requires special handling, normally under the supervision of a
pharmacist.
Inert A substance that is not chemically active or hazardous.
Page 2 of 9
F asu-002-002-01

Wearable equipment designed to protect the worker from harm or injury

Personal Protective when handling hazardous waste, where there is a danger of exposure to
Equipment (PPE) liquids, vapors, or dust, as well as physical hazards, such as sharp edges.
PPE includes o les, mask, a ron loves, and boots.
Pharmaceutical products damaged beyond recovery, no longer needed, or
past their expiration date. May include tablets, powders, ointments, liquids,
Pharmaceutical waste sharps, semi-solids, solids, and lab reagents. This may also include
roduct acka in unless uncontaminated and ro erl se re ated.
Items that can cause cuts or puncture wounds, including needles,
Sharps waste hypodermic needles, scalpels and other blades, and broken glass.
Whether or not they are infected, such items are considered infectious
waste and therefore hi hi hazardous healthcare waste.
5. References
1. SOP-QSU-002 Writing, Reviewing, Approving, and Controlling Quality Management System
Documentation
2. SOP-QSU-003 Evaluation and Recording of Training on QMS Documents
3. SOP-FFL-S016-Destruction of Rejected Goods
4. Wl-QAU-005-003 Quarantine of Products by Quality Control
5. Wl-QAU-007-001 Disposal of Damaged, Refused, or Unusable Pharmaceutical Products -
USG Owned Products in SCMS Custody in SCMS Focus Country
6. Wl-QAU-007-002 Disposal of Unusable Pharmaceutical Products - SCMS Assisting Client in
the Disposal of Their Goods
7. F-QAU-007-001 SCMS Product Disposal List Template
8. F-QAU-007-002 Non-SCMS Product Disposal List Template
9. Expert Committee on Specifications for Pharmaceutical Preparations,
http://www.who.int/medicines/services/expertcommittees/pharmprep/GDP counterfeits QAS
08 252 11012008.pdf
10. "Guidelines for Safe Disposal of Unwanted Pharmaceuticals in and after Emergencies,
WHO/EDM/PAR/99.2"
11 . http://www.who.int/water sanitation health/medicalwaste/unwantpharm.pdf
12. Health care waste management resources from PATH, including sorting and other essential
principles of safe management of healthcare waste.
http://www.path.org/projects/health care waste resources.php
13. Medline Plus, service of U.S. National Library of Medicine and National Institutes of Health,
http://www.nlm.nih.gov/medlineplus/mplusdictionarv.html
14. The Basel Convention on the Control of Transboundary Movements of Hazardous Wastes
and their Disposal. http://www.basel.int/
15. The Stockholm Convention on Persistent Organic Pollutants is a global treaty to protect
human health and the environment from chemicals that remain intact in the environment for
long periods, become widely distributed geographically and can lead serious health effects.
http://chm.pops.int/Convention/tabid/54/language/en-US/Default.aspx#convtext/
All references made above are at the latest document issue or revision level
Page 3 of 9
PFSCM
F-QSU--002--002--01

6. Procedures for Preparation and Disposal of Unusable Pharmaceutical Products
Background
During the course of pharmaceutical distribution, products are occasionally damaged or are held past
their expiration date and are no longer useable. Pharmaceutical waste may also result from periodic
"de-junking" or routine inventory clearance processes. Pharmaceutical waste is no longer medicine; it
is chemical waste and must be disposed of in an environmentally safe and permanent manner. When
SCMS staff is involved in the disposal, it is important for them to monitor and ensure that the disposal
of unusable pharmaceuticals is conducted using a well-documented procedure that ensures both the
employee and public safety, and poses minimal risk to the environment.
This set of Standard Operating Procedures (SOP) and Work Instructions (WI) are intended for any
SCMS staff members or contractors who may become involved in disposal procedures. SCMS staff
members or contractors may become involved in the disposal of unusable pharmaceutical products in
one of two scenarios:
• SCMS assists a client in the disposal of their unusable pharmaceutical products

• SCMS staff members or contractors may be involved in the disposal of USG-owned products
in SCMS custody held in distribution centers under bond or in transit, i.e., before they have
been assigned a proof of delivery (POD). This scenario is subject to a separate set of Work
Instructions.
6.1 Preparation and Authorization for Disposal
1. The Responsible Pharmacist/RDC/Freight & Logistics (F&L) or designate will identify and
quarantine pharmaceutical waste in a secure area inaccessible to unauthorized personnel and
protected from the weather.
2. For USG-owned products in SCMS custody, the Responsible Pharmacist or F&L manager will
prepare a proposed Pharmaceutical Disposal List (F-QAU-007-001 or F-QAU-007-002) with
the following information:
a. Product description, including manufacturer
b. Strength
c. Presentation
d. Units
e. Quantity/volume
f. Batch number
g. Responsible Pharmacist or FFL manager signature.
3. The Responsible Pharmacist/RDC or responsible SCMS-designee forwards the proposed
Pharmaceutical Disposal List, disposal protocol and local and national regulatory authority
concurrences to the Senior Contracts Officer, Contracts Manager and Global Inventory and
Principal Waste Management Advisor.
Page 4 of 9
F-QSU-002--002--01

4. If the reason for destruction is damage possibly due to vendor or shipper negligence then an
incident report shall be filed to prompt an investigation. The Senior Contracts Officer reviews the
causes of damage and determines if there is vendor or shipper liability for the damages, and if
so the Contracts Officer files claims. If there is no shipper or vendor liability the Senior
Contracts Officer investigates filing an insurance claim for the damages. After the Senior
Contracts Officer concludes that investigation the Principal Waste Management Advisor
reviews the proposed disposal protocol to assure that they meet SCMS standards and if so,
approves them and forwards the document to the GIM for approval. Following the GIM
approval the list is forwarded to Contracts Manager to obtain USAID concurrence.
5. After the USAID concurrence is obtained, the approved Pharmaceutical Disposal List is sent to
the Responsible Pharmacist/RDC or SCMS designate who authorizes the disposal in
accordance with the approved protocols.
6. The QC Specialist conducts quarterly reviews of the expiry date report for analytical samples
stored in the Retention Store, to identify those which have passed their expiry date plus at
least 1 month. The proposed disposal list is sent to the Product Quality Manager for approval.
After approval has been obtained, the QC Specialist will take the samples to North-West
University (NWU) under chain of custody for disposal. The samples will be disposed by NWU
in accordance with applicable procedures - the disposal and removal of pharmaceutical,
chemical, medical, and other bulk waste.
6.2 Procedures for Disposal of Unusable Pharmaceutical Products
1. If disposal resources are not available in the country and/or export is not permitted, contact the
Deputy Director, Global Supply Chain or the Principal Waste Management Advisor.
2. The Responsible Pharmacist, SCMS designate, or RDC Manager issues a Request-for-
Proposal (RFP) to identify a waste processing service or contractor to perform the defined
disposal, taking into account national and local standards and the disposal capacity available
in country. The solicitation may be limited to companies on an approved list provided by the
client and, upon identifying an appropriate disposal firm, issues the contract in compliance with
the Federal Acquisition Regulations (FARS) and national law. The Responsible
Pharmacist/SCMS designate will specify in the RFP that only waste disposal companies that
adhere to national and local waste management regulations and have permits and approvals
required by the appropriate authorities will be considered. The selected company must provide
to SCMS verification of those authorizations in writing.
3. The Responsible Pharmacist, SCMS designate or RDC Manager will arrange with the
contracted waste processing contractor to remove the waste identified for disposal after
approval has been received from the national and local authorities, the indicated SCMS
officers and the USAID. The Responsible Pharmacist or designate will accompany the goods
to the disposal site, witness the disposal and obtain a copy of the Disposal Certificate.
Page 5 of 9
PFSCM
F-QSU-002-002-01

4. The SCMS Global Inventory Manager adjusts the stock level as necessary in Orion once it has
been authorized. The cost of the destruction process will be retained in Knowledge Tree in the
QANVaste Disposal/Hazardous Waste folder, in the appropriate country folder, for monitoring
purposes.
6.3 Methods for Disposal of Unusable Pharmaceutical Products

NOTE: This section describes the main methods recommended by World Health Organization (WHO)
for the disposal of unusable pharmaceutical products which cannot be recycled. Nearly all countries
require that the actual disposal be carried out by a service or company that is trained and certified to
do so. The methods are described here for the purpose of background and to inform discussions
between SCMS and partners in country.
1. Wherever feasible, unusable pharmaceuticals should be incinerated in high-temperature
incinerators (greater than 900 °C) that are equipped with functional emission controls.
2. Large amounts of unusable pharmaceuticals should be incinerated in specialized chemical
waste incinerators fitted with toxic fume removal mechanisms, such as scrubbers. Medical
waste incinerators not fitted with emissions controls can be used for small quantities of low-
toxicity pharmaceuticals, if the waste is added in small quantities interspersed with other
medical waste to ensure good combustion, and to avoid high concentrations of noxious gases
such as nitrogen and sulfur oxides. Other combustion units designed for industrial waste, such
as cement kilns, are also suited for the incineration of pharmaceuticals provided they reach
high temperature and are fitted with emissions controls. In some countries, cement producers
accept certain types of pharmaceutical waste as an alternative fuel, thus reducing fuel costs.
3. Because high-temperature incineration is not always available, alternative destruction
methods must be considered. Alternative destruction methods must meet national and local
environmental and health standards and technical requirements for the volume and category
of pharmaceutical product waste. Acceptable methods are listed in order of that which is
recommended.
4. Encapsulation: Unusable pharmaceutical products may be blended in an immobilizing
solution in a plastic or steel drum and disposed of in a landfill. Drums should be cleaned prior
to use and should not have contained explosive or hazardous materials previously. Drums
should be filled to 75% capacity with solid and semi-solid pharmaceuticals with a mixture of
cement or cement/lime mixture, plastic foam, or bituminous sand added until filled to capacity.
Drums should be sealed completely, ideally by seam or spot welding for steel drums. For
ease of movement, drums may be placed on pallets which can then be put on a pallet
transporter. Sealed drums should be placed at the base of a landfill and covered with fresh
municipal solid waste.
Page 6 of 9
F-OSU--002--002--01

5. lnertization: lnertization is a variant of encapsulation and involves removing the packaging

materials, paper, cardboard, and plastic from pharmaceutical products. The products (65%)
then are mixed with water (5%), cement (15%) and lime (15%) is added to form a
homogenous paste. The paste may be transported by a concrete mixer truck to a landfill and
decanted into the normal urban waste or filled into plastic or other containers and allowed to
solidify before burial in a land fill. Alternatively, a homogenous mass is formed and cubes or
pellets are produced on-site and transported to a suitable storage site. Packaging material may
be recycled at a local recycling facility or disposed of as municipal waste. It should be noted
that the drug entity may not be destroyed in this procedure but the access to it and its leaching
is markedly reduced.
6. Low/medium temperature incineration (<900 °C): Small quantities of pharmaceutical waste
can be incinerated in single-chamber incinerators, such as drum or brick incinerators, and
resulting ashes and residues disposed of in an engineered landfill. Glass ampoules should be
segregated from pharmaceutical waste streams prior to incineration in non-industrial
incinerators.
7. Direct landfill disposal: Small quantities of pharmaceutical waste may be placed in a landfill
without prior treatment provided that the pharmaceuticals are dispersed in large quantities of
general waste. Landfills with engineering controls, such as sanitary landfills, should be
selected over open dumps.
8. Cytotoxic and narcotic drugs however, should never be placed in a landfill, even in small
quantities. Placing large quantities of pharmaceuticals in a landfill is not recommended unless
the waste is encapsulated and disposed in sanitary landfill sites, where the risk of groundwater
contamination is minimized.
SCMS recognizes that discharge into a sewer is also a common disposal practice in some
countries, but as a matter of policy SCMS does not support this procedure except in rare cases for
products which do not contain active pharmaceutical ingredients, e.g., saline-based parenteral
solutions.
The SCMS Responsible Pharmacist or designate is responsible and accountable to ensure that
the waste disposal method and location selected is in accordance with the technical guidelines
listed herein.
Where acceptable disposal methods are not available in country, the Responsible Pharmacist or
designate will contact the Global Inventory and Product Quality Assurance Managers to negotiate
the possibility of exporting the unusable pharmaceuticals to appropriate disposal facilities in
compliance with the Basel Convention rules.
Page 7 of 9
PFSCM
F-QSU-002-002-01

7. Records
1. F-QAU-007-001-SCMS Product Disposal List
2. F-QAU-007-002-Non-SCMS Product Disposal List
8. Distribution
1. QAU Staff
2. Knowledge Tree
9. Annex Documents
1. Attachment 1: Training Evaluation Checklist
10. Amendment History

Amendment History
Revision: Effective Date: Changed Bv: Reason:
1 10-16-2009 Marcia Rock Original Author
2 12-15-2013 Julie Craig Updated QMS template and revisions
for annual review. Numbering changed
by the QA department, (not the waste
advisor.) Responsibility matrix removed.
11. Additional Reviewers

Revision: Name: Title: Date: Comments:
2
3
4
Page 8 of 9
F-OSU-002-002--01

Attachment 1
TRAINING EVALUATION CHECKLIST
To ensure complete understanding, please answer the following questions on this SOP.
1. T/F Pharmaceutical products consist only of tablets.
2. T/F Sharps are not infectious materials.
3. T/F Pharmaceutical waste can be landfilled.
4. T/F The Pharmacists must quarantine pharmaceutical waste so that it is not distributed.
5. T/F This SOP may be adapted to the host country.
NAME SIGNATURE DATE
COMPLETED BY:
---------
EVALU ATE D BY:
SUCCESSFUL: YES/NO
IF NO, ADVISE OF IMPROVEMENT PLAN:
NAME SIGNATURE DATE
EMPLOYEE:
DEPT MGR:
Page 9 of 9

SOP-QAU-007-02-Disposal of Unusable Pharmaceutical Products

Hochgeladen von

Dokumentinformationen

Originalbeschreibung:

Copyright

Verfügbare Formate

Dieses Dokument teilen

Dokument teilen oder einbetten

Freigabeoptionen

Stufen Sie dieses Dokument als nützlich ein?

Sind diese Inhalte unangemessen?

Copyright:

Verfügbare Formate

SOP-QAU-007-02-Disposal of Unusable Pharmaceutical Products

Hochgeladen von

Copyright:

Verfügbare Formate

PFSCM Knowledge Tree Official Copy

Standard Operating Procedure

Section: Number: Title: Revision:

Name Title Si nature* Date

Lead Author J. Craig

Section: Number: Title: Revision:

Section: Number: Title: Revision:

Wearable equipment designed to protect the worker from harm or injury

Section: Number: Title: Revision:

6. Procedures for Preparation and Disposal of Unusable Pharmaceutical Products

• SCMS assists a client in the disposal of their unusable pharmaceutical products

6.1 Preparation and Authorization for Disposal

Section: Number: Title: Revision:

Section: Number: Title: Revision:

6.3 Methods for Disposal of Unusable Pharmaceutical Products

Section: Number: Title: Revision:

5. lnertization: lnertization is a variant of encapsulation and involves removing the packaging

Section: Number: Title: Revision:

10. Amendment History

11. Additional Reviewers

Section: Number: Title: Revision:

1. T/F Pharmaceutical products consist only of tablets.

2. T/F Sharps are not infectious materials.

3. T/F Pharmaceutical waste can be landfilled.

5. T/F This SOP may be adapted to the host country.

NAME SIGNATURE DATE

IF NO, ADVISE OF IMPROVEMENT PLAN:

NAME SIGNATURE DATE

Das könnte Ihnen auch gefallen