Self-assessment & Evaluation of Good

Distribution & Storage Practices

Implementation
Purpose
Self-assessment enables the organization to examine its daily activities and assess them against the
GSDP guidelines. It aims to position the organization to fulfil the requirements of the GSDP and
examine the evolution of the situation. It also helps identify compliance matters, but also areas for
improvement.

Chapters
1 Organization & Management
2 Personnel
3 Quality System
4 Premises
5 Vehicles & Equipment
6 Shipping Containers & Containers Labeling
7 Dispatch & Receipt
8 Documentation
9 Repacking & Relabeling
10 Complaints
11 Recalls
12 Returned Products
13 Counterfeit Pharmaceutical Products
14 Importation
15 Contract Activities
16 Internal quality Audit
17 Self-Inspections
18 Measurement Analysis & Improvement
19 Going green

2017 1 396479690.xls
 k

2017 2 396479690.xls
2017 3 396479690.xls
 Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

Name & function of the referent

Name & function of personnel who participated in the self assessment

Meeting dates
Meet Requirement Comments
Guidelines (Note relevant information relating to the guideline, specifying the actions
undertaken or underway or planned to meet requirement)

2017 4 396479690.xls
 Comments
Guidelines (Note relevant information relating to the guideline, specifying the actions
Yes No undertaken or underway or planned to meet requirement)

1. ORGANIZATION AND MANAGEMENT

Organization chart defines responsibilities,

authorities and interrelationships of all
1.1
personnel to assure processes for product
selection and quality are not compromised

Duties and responsibilities are

communicated and understood by concerned
1.2
individuals through documented and
reviewed job descriptions

A qualified person accountable on

implementing, maintaining and reporting to
top management on the performance of the
1.3 quality management system and any need for
improvement and ensuring the promotion of
awareness of customer requirements
throughout the warehouse, is appointed

Management and personnel are not subject to

1.4 commercial, political, financial and other
pressures or conflict of interest

The warehouse determines, provides and

maintains the infrastructure needed to
achieve conformity to product requirements
1.5
(Buildings, workspace and associated
utilities, process equipment, supporting
services etc.)

2017 5 396479690.xls
 The warehouse determines and manages the
work environment needed to achieve
1.6 conformity to product requirements (noise,
temperature, humidity, lighting or weather
etc.)

Proposed Improvement
Actions

Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

1. Organization And Management Summary

# Of Conformities

# Of Non-Conformities

Strengths

Weaknesses

Action Plan

2017 6 396479690.xls
 Action Deadline Result

2017 7 396479690.xls
 Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

Name & function of the referent

Name & function of personnel who participated in the self assessment

Meeting dates
Meet Requirement Comments
Guidelines (Note relevant information relating to the guideline, specifying the actions
Yes No undertaken or underway or planned to meet requirement)

2. PERSONNEL

Personnel involved in distribution and

2.1 storage activities are competent and regularly
trained

The warehouse determines the necessary

competency for personnel involved in the
2.2
different aspects of the distribution process
and provides needed training

Written standard operating procedures for

personnel training exist

2017
2.3 8 396479690.xls
 Training is performed in accordance with a
written training program and they should be
assessed as applicable to evaluate the
effectiveness of the actions taken
2.3
Appropriate records should be maintained,
including details of subjects covered and
participants trained

Delivered trainings cover the topic of

product security, product identification, the
detection of counterfeits and the avoidance
of counterfeits entering the supply chain

Sufficient number of competent personnel

involved in the distribution and storage
2.4 activities is available, such that no one
person is overburdened with responsibilities
increasing the risk to product quality

Personnel training shall are based on written

standard operating procedures (SOPs)

There is a training program written for each

2.5 personnel

Appropriate records are maintained,

including details of subjects covered and
participants trained

2017 9 396479690.xls
 Delivered trainings cover the topic of good
storage and distribution practices, product
security, as well as aspects of product
identification, the detection of counterfeits
and the avoidance of counterfeits entering
2.6 the supply chain and how to deal with
hazardous pharmaceutical products

Safety procedures relating to all relevant

aspects including the safety of personnel and
property, environmental protection and
product integrity, are in place

Personnel is wearing appropriate protective

uniforms and are provided needed personal
protective equipment

Procedures relevant to personnel hygiene,

covering health, hygiene and clothing of
personnel are documented and implemented

2.7-2.8

Smoking, eating, drinking, chewing and the

storage of food should be restricted to certain
designated areas separate from storage areas

2017 10 396479690.xls
 Personnel suffering from an infectious
disease or having open lesions on the
exposed surface of the body are not engaged
in activities that could result in
compromising the quality of the products

Procedures relevant to codes of practice and

disciplinary actions to address
2.9 misappropriation, tampering, diversion or
counterfeiting of products are documented
and implemented

Proposed Improvement
Actions

Proposed Improvement
Actions

Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

2. Personnel Summary

# Of Conformities

# Of Non-Conformities

2017 11 396479690.xls
Strengths

Weaknesses

Action Plan
Action Deadline Result

2017 12 396479690.xls
2017 13 396479690.xls
2017 14 396479690.xls
 Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

Name & function of the referent

Name & function of personnel who participated in the self assessment

Meeting dates
Meet Requirement Comments
Guidelines (Note relevant information relating to the guideline, specifying the actions
Yes No undertaken or underway or planned to meet requirement)

3. QUALITY SYSTEM & TRACEABILITY OF PHARMACEUTICAL PRODUCTS

A quality policy reflecting the distributor

3.1 quality intentions and commitment is
documented, signed and communicated

Risk assessments are conducted by

distributors to assess and address potential
3.2
risks to the quality and integrity of
pharmaceutical products

Review the quality management system at

planned intervals during the management
review meeting - Records from management
review are maintained

3.3-3.4
2017 15 396479690.xls
 3.3-3.4
Inputs to management review includes
information on results of audits, customer
feedback, process performance and product
conformity, status of preventive and
corrective actions and follow-up actions
from previous management reviews.
Opportunities for improvement

Activities of inspection, auditing and

certification of compliance with a quality
3.5 system by external bodies is conducted (such
as the International Standardization
Organization (ISO) series)

The warehouse foster a safe, transparent and

secure distribution system which includes
product traceability throughout the supply
chain
3.6

A procedures is in place to ensure

traceability of products received and
distributed in order to facilitate product recall

All parties involved in the supply chain are

3.7 identified, depending on the product’s type
and national policies and legislations.

2017 16 396479690.xls
 Measures ensures that pharmaceutical
products have documentation that can be
used to permit traceability of the products
3.8 throughout distribution channels from the
manufacturer/importer to the entity
responsible for selling or supplying the
product to the patient or his or her agent.

Proposed Improvement
Actions

Proposed Improvement
Actions

Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

3.Quality System

# Of Conformities

# Of Non-Conformities

Strengths

2017 17 396479690.xls
Weaknesses

Action Plan
Action Deadline Result

2017 18 396479690.xls
2017 19 396479690.xls
s
Implem
entatio
n
Propos
3.
ed
Qual
Improv
ement
ity
Actions
Syst
em
&
Trac
eabil
ity of
Phar
# Of
Confor
mac
mities
eutic
#alOf
Non-
Prod
Confor
mities
ucts
Sum
Strengt
mar
hs
y
Weakn
esses

Acti
on
Plan
Action Deadline Result

2017 20 396479690.xls
2017 21 396479690.xls
2017 22 396479690.xls
 Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

Name & function of the referent

Name & function of personnel who participated in the self assessment

Meeting dates
Meet Requirement Comments
Guidelines (Note relevant information relating to the guideline, specifying the actions
Yes No undertaken or underway or planned to meet requirement)

4. PREMISES, WAREHOUSING AND STORAGE

Storage areas are of sufficient capacity to

allow the proper storage of the various
4.1
categories of pharmaceutical products and of
non conforming products

Storage areas are designed and operated in a

way to ensure cleanliness, appropriate
hygiene and a minimization of cross
contamination risks

Storage areas are maintained within

acceptable temperature limits

4.2

2017 23 396479690.xls
 4.2

Pharmaceutical products should be stored off

the floor and suitably spaced to permit
cleaning and inspection

Pallets should be kept in a good state of

cleanliness and repair.

Adequate lighting is provided in all areas to

4.3 enable all operations to be carried out
accurately and safely

Premises and storage areas undergo

regularly a pest control program or pest
control activities are subcontracted at
planned intervals to a specialized entity
followed up regularly

Material data sheets of pesticides are

available

Pest control map is available and baits are

4.4
identified and controlled on site

2017 24 396479690.xls
 4.4

Supplier visit reports are maintained

Documented procedure exists for reporting

incidents and following up corrective actions

Spillages are cleaned up as soon as possible.

4.5 Written procedures are in place for the
handling of such occurrences

Precautions are taken to prevent

4.6 unauthorized persons from entering storage
areas

Written procedure are in place to identify the

potential for emergency situations
(firefighting, flooding and other
emergencies) and to respond to such
emergency situations. This procedure shall
4.7 be tested and reviewed periodically where
practical

This procedure is tested and reviewed

periodically where practical

2017 25 396479690.xls
 Receiving and dispatch bays protect
pharmaceutical products from the weather

4.8
Receiving areas are designed and equipped
to allow incoming containers of
pharmaceutical products to be cleaned, if
necessary, before storage

The temporary storage of rejected, expired,

recalled or returned products and suspected
4.9 counterfeits is identified and segregated from
other products until a decision as to their
future has been made

Any system replacing physical quarantine

provide equivalent security; For example,
computerized systems can be used, provided
that they are validated to demonstrate
4.1o security of access

Quarantine areas are clearly marked and

access restricted to authorized personnel

Drugs are stored in designated areas

4.11
according to the Act No. 673/98

2017 26 396479690.xls
 Pharmaceutical products due to expire first
are sold and/or distributed first (first expiry/
first out (FEFO))

4.12
Exceptions may be permitted as appropriate,
provided that adequate controls are in place
to prevent the distribution of expired
products

Storage conditions for pharmaceutical

4.13 products are in compliance with the
recommendations of the manufacturer

Temperature and humidity control systems

specify tolerable limits for time and
temperature and humidity variations and
recording devices are checked and calibrated
at regular intervals

Warehouse has been temperature mapped

and an adequate number of monitoring
devices are located throughout the facility
4.14 -
4.15
Documentation indicates compliance with
temperature and storage conditions for each
stored product

2017 27 396479690.xls
 All monitoring records are kept for a
minimum of the shelf-life of the product
distributed plus one year

Periodic stock reconciliation is performed by

4.16 comparing the actual and recorded stocks
and discrepancies are investigated

Proposed Improvement
Actions

Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

4. Premises, Warehousing & Storage Summary

# Of Conformities

# Of Non-Conformities

Strengths

2017 28 396479690.xls
Weaknesses

Action Plan
Action Deadline Result

2017 29 396479690.xls
2017 30 396479690.xls
 Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

Name & function of the referent

Name & function of personnel who participated in the self assessment

Meeting dates
5. VEHICLES AND EQUIPMENT

Pharmaceutical products are transported in

accordance with procedures such that: the
identity of the product is not lost; the product
does not contaminate and is not
5.1 contaminated by other products; adequate
precautions are taken against spillage,
breakage, misappropriation and theft;
appropriate environmental conditions are
maintained

Procedures are in place for operation and

5.2 maintenance of all vehicles and equipment
involved in the distribution process

2017 31 396479690.xls
 Vehicles and equipment used to distribute,
store or handle pharmaceutical products are
suitable to prevent any source of
5.3
contamination. Sufficient capacity to allow
orderly storage of the various categories of
pharmaceutical products

The design and use of vehicles and

equipment permit effective cleaning and/or
maintenance

5.4

A written cleaning and maintenance program

indicates the frequency of cleaning and
maintenance

Written program for pest control is available

to ensure that vehicles, containers and
equipment are kept free from pests

Material data sheets of pesticides are

available

Pest control map is available and baits are

5.5
identified and controlled on site

2017 32 396479690.xls
 5.5

Supplier visit reports are maintained

Documented procedure exists for reporting

incidents and following up corrective actions

Where special storage conditions are

required during transportation, these are
provided, checked, monitored and recorded

5.6

All monitoring records are kept for a

minimum of the shelf-life of the product
distributed plus one year

Equipment used for monitoring conditions

5.7
should be calibrated at regular intervals

Defective vehicles and equipment are labeled

5.8
or removed from service until maintained

2017 33 396479690.xls
 Drivers responsible for the transportation of
pharmaceutical products are to be informed
about all relevant conditions for storage and
5.9
transportation. These requirements are to be
adhered to throughout transportation and at
any intermediate storage stages

Toxic, radioactive material, and other

dangerous pharmaceutical products are
5.1o
transported in safe and secure containers and
vehicles and stored in safe and secure areas

Mechanisms should be available to allow for

the segregation during transit of rejected,
recalled and returned pharmaceutical
products as well as those suspected of being
counterfeits
5.11

Such goods should be securely packaged,

clearly labeled, and be accompanied by
appropriate supporting documentation

Measures should be in place to prevent

unauthorized persons from entering and/or
5.12 tampering with vehicles and/or equipment,
as well as to prevent the theft or
misappropriation thereof

2017 34 396479690.xls
 Where feasible, technology, such as global
positioning system (GPS) electronic tracking
5.13 devices and others are used to enhance the
security of pharmaceutical products while in
the vehicle

Where applicable, written agreements with

carriers are available to ensure that
appropriate measures are taken to safeguard
pharmaceutical products
5.14

Written agreements are in line with national

and regional regulatory requirements.

Proposed Improvement
Actions

Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

5. Vehicles & Equipment Summary

# Of Conformities

# Of Non-Conformities

2017 35 396479690.xls
Strengths

Weaknesses

Action Plan
Action Deadline Result

2017 36 396479690.xls
2017 37 396479690.xls
2017 38 396479690.xls
 Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

Name & function of the referent

Name & function of personnel who participated in the self assessment

Meeting dates
Meet Requirement Comments
Guidelines (Note relevant information relating to the guideline, specifying the actions
Yes No undertaken or underway or planned to meet requirement)

6. SHIPPING CONTAINERS AND CONTAINER LABELLING

Pharmaceutical products are stored and

6.1
distributed in protective shipping containers

Labels applied to shipping containers are

clear and provide sufficient information on
6.2 handling and storage conditions. Enable
identification of content and source of
container.

Special transport and/or storage conditions

are indicated on the label

6.3

2017 39 396479690.xls
 6.3

Internationally and/or nationally accepted

abbreviations, names or codes are used in the
labelling of containers

Written procedures are available for the

6.4 handling of damaged containers and
dangerous products

Proposed Improvement
Actions

Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

6. Shipping Containers & Container Labeling Summary

# Of Conformities

# Of Non-Conformities

Strengths

2017 40 396479690.xls
Weaknesses

Action Plan
Action Deadline Result

2017 41 396479690.xls
2017 42 396479690.xls
 Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

Name & function of the referent

Name & function of personnel who participated in the self assessment

Meeting dates
Meet Requirement Comments
Guidelines (Note relevant information relating to the guideline, specifying the actions
Yes No undertaken or underway or planned to meet requirement)

7. DISPATCH AND RECEIPT

Pharmaceutical products are sold and/or

distributed to persons or entities that are
authorized to acquire such products in
7.1
accordance with the applicable national,
regional and international legislation. Written
proof needed of authority.

The dispatch and receipt of the goods are

7.2
documented

Written procedures for the dispatch and

release of products are established

7.3
2017 43 396479690.xls
 7.3

Pharmaceutical products under quarantine

require release for dispatch by the person
responsible for quality

Records for dispatch are retained. They state

at least the date of dispatch, the customer’s
name and address, the product description,
7.4
e.g. name, form and strength (if appropriate),
batch number and quantity, applicable
transport and storage conditions

Records of dispatch contain enough

information to enable traceability of the
7.5
pharmaceutical product (batch number,
expiry date)

Delivery schedules and route planning are

7.6
established

Vehicles and containers are loaded carefully

7.7 on a first-out/last-in basis in to prevent
physical damage

2017 44 396479690.xls
 Products are not supplied or received after
7.8
or near their expiry date

Proposed Improvement
Actions

Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

7. Dispatch & Receipt Summary

# Of Conformities

# Of Non-Conformities

Strengths

Weaknesses

Action Plan
Action Deadline Result

2017 45 396479690.xls
2017 46 396479690.xls
2017 47 396479690.xls
 Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

Name & function of the referent

Name & function of personnel who participated in the self assessment

Meeting dates
Meet Requirement Comments
Guidelines (Note relevant information relating to the guideline, specifying the actions
Yes No undertaken or underway or planned to meet requirement)

8. DOCUMENTATION

Written procedures, instructions and records

are available which document all activities
relating to the distribution of pharmaceutical
8.1
products, including all applicable receipts
and issues. The name of the applicable entity
should appear on all relevant documents

The title, nature and purpose of each

document is clearly stated. The contents of
8.2 documents are clear and unambiguous.
Documents are laid out in an orderly fashion
and are easy to check.

2017 48 396479690.xls
 A control of documents procedure exists for
the preparation, review, approval, use of and
8.3 control of changes to all internal and external
documents relating to the distribution
process

All documents are completed, approved,

signed (as required) and dated by an
8.4
appropriate authorized person(s) and are not
changed without the necessary authorization

Records should contain at least the following

information: date, name of the
8.5 pharmaceutical product, quantity received or
supplied and name and address of the
supplier

All records are readily retrievable, and are

stored and retained using facilities that are
8.6 safeguarded against unauthorized
modification, damage, deterioration and/or
loss of documentation

Permanent records, written or electronic,

exist for each stored product indicating
recommended storage conditions, any
precautions to be observed and retest dates
8.7

Pharmacopoeial requirements and current

national regulations concerning labels and
containers are respected at all times

2017 49 396479690.xls
 Where the records are generated, there are
copies (soft and hard) kept to prevent any
accidental data loss

8.8

Backup systems for electronic documents

and records to prevent any data loss

Proposed Improvement
Actions

Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

8. Documentation

# Of Conformities

# Of Non-Conformities

Strengths

2017 50 396479690.xls
Weaknesses

Action Plan
Action Deadline Result

2017 51 396479690.xls
2017 52 396479690.xls
 Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

Name & function of the referent

Name & function of personnel who participated in the self assessment

Meeting dates
Meet Requirement Comments
Guidelines (Note relevant information relating to the guideline, specifying the actions
Yes No undertaken or underway or planned to meet requirement)

9. REPACKING AND RELABELING

Repackaging and relabeling of

pharmaceutical products are not be allowed,
9.1
as these practices may represent a risk to the
safety and security of the supply chain

Printing and/or adding extra stickers is not

9.2 allowed unless authorized by the concerned
entity

The re-printing is forbidden in the law No.

9.3
367/1994 related to pharmacy profession

2017 53 396479690.xls
Proposed Improvement
Actions

Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

9. Repacking & Relabeling Summary

# Of Conformities

# Of Non-Conformities

Strengths

Weaknesses

Action Plan
Action Deadline Result

2017 54 396479690.xls
2017 55 396479690.xls
2017 56 396479690.xls
 Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

Name & function of the referent

Name & function of personnel who participated in the self assessment

Meeting dates
Meet Requirement Comments
Guidelines (Note relevant information relating to the guideline, specifying the actions
Yes No undertaken or underway or planned to meet requirement)

10 . COMPLAINTS

A written procedure is in place for the

handling of complaints

Complaints are distinguished between

10.1 product or packaging defect and those
related to distribution

The original manufacturer and/or marketing

authorization holder is informed in the case
of a complaint about the quality of a product
or its packaging

2017 57 396479690.xls
 All complaints and other information
concerning potentially defective and
potentially counterfeit pharmaceutical
products are reviewed carefully according to
written procedures describing the action to
be taken, including the need to consider a
10.2 recall where appropriate

If a defect relating to a pharmaceutical

product is suspected, other batches of the
same product are also checked

Appropriate follow-up actions are taken after

investigation and evaluation of the complaint

10.3
The complaint, the response received from
the original product manufacturer, or the
results of the investigation of the complaint,
are shared with all the relevant parties

Proposed Improvement
Actions

Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

10. Complaints Summary

2017 58 396479690.xls
# Of Conformities

# Of Non-Conformities

Strengths

Weaknesses

Action Plan
Action Deadline Result

2017 59 396479690.xls
2017 60 396479690.xls
2017 61 396479690.xls
 Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

Name & function of the referent

Name & function of personnel who participated in the self assessment

Meeting dates
Meet Requirement Comments
Guidelines (Note relevant information relating to the guideline, specifying the actions
Yes No undertaken or underway or planned to meet requirement)

11. RECALLS

Written procedures for recall are available.

11.1 These procedures are be checked regularly
and updated by a designated person

The original manufacturer is informed in the

event of a recall

11.2

Information on a recall shall be shared with

the appropriate national regulatory authority

2017 62 396479690.xls
 The effectiveness of the arrangements for
11.3 recalls should be evaluated at regular
intervals

Recalled pharmaceutical products are

segregated during transit and clearly labelled
as recalled products

11.4

All recalled pharmaceutical products are

stored in a secure, segregated area pending
appropriate action

The storage conditions applicable to a

pharmaceutical product which is subject to
11.5
recall are maintained during storage and
transit

All customers and competent authorities of

all countries to which a given pharmaceutical
11.6 product may have been distributed are
informed promptly of any intention to recall
the product

All records are readily available to a

designated person(s) responsible for recalls.
11.7 These records contain sufficient information
on pharmaceutical products supplied to
customers (including exported products)

2017 63 396479690.xls
 The progress of a recall process is recorded
11.8
and a final report is issued

Proposed Improvement
Actions

Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

11. Recalls Summary

# Of Conformities

# Of Non-Conformities

Strengths

Weaknesses

Action Plan

2017 64 396479690.xls
 Action Deadline Result

2017 65 396479690.xls
2017 66 396479690.xls
 Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

Name & function of the referent

Name & function of personnel who participated in the self assessment

Meeting dates
Meet Requirement Comments
Guidelines (Note relevant information relating to the guideline, specifying the actions
Yes No undertaken or underway or planned to meet requirement)

12. Returned Products

Distributor receives pharmaceutical product

returns or exchanges pursuant to the terms
and conditions of the agreement between the
distributor and the recipient
12.1
Both distributors and recipients are
accountable for administering their returns
process and ensuring that the aspects of this
operation are secured and do not permit the
entry of counterfeit products

The necessary assessment and decision

regarding the disposition of such products is
made by a suitably authorized person

12.2
2017 67 396479690.xls
 The nature of the product returned to the
distributor, any special storage conditions
12.2 required, its condition and history and the
time elapsed since it was issued, are taken
into account in this assessment

Where any doubt arises over the quality of a

pharmaceutical product, it is not considered
suitable for reissue or reuse

Storage conditions applicable to

pharmaceutical product rejected or returned
12.3 should be maintained during storage and
transit until such time as a decision has been
made regarding the product in question

Appropriate procedures for the management

12.4 of rejected pharmaceutical products and
those returned to a distributor are in place

Products are manipulated in accordance with

international, national and local requirements
12.5 regarding disposal of such products, and
with due consideration to protection of the
environment

Records of all returned, rejected and/or

12.6 destroyed pharmaceutical products are kept
for a predetermined period

2017 68 396479690.xls
 The procedure of products returned is in
compliance with the protocol issued between
the Syndicate of Pharmacists and the
12.7
Syndicate of pharmaceutical importers and
owners of warehouses in Lebanon in
01/09/2006

Proposed Improvement
Actions

Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

12. Returned Products Summary

# Of Conformities

# Of Non-Conformities

Strengths

Weaknesses

2017 69 396479690.xls
 Action Plan
Action Deadline Result

2017 70 396479690.xls
2017 71 396479690.xls
 Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

Name & function of the referent

Name & function of personnel who participated in the self assessment

Meeting dates
Meet Requirement Comments
Guidelines (Note relevant information relating to the guideline, specifying the actions
Yes No undertaken or underway or planned to meet requirement)

13. Counterfeit Pharmaceutical Products

Counterfeit pharmaceutical products found

in the distribution chain are kept apart from
other pharmaceutical products to avoid any
confusion

Counterfeit pharmaceutical products are

13.1
clearly labeled as not for sale

National regulatory authorities and the

holder of the marketing authorization for the
original product are informed immediately

2017 72 396479690.xls
 Where applicable, the warehouse using
holograms to identify and prevent the
proliferation of counterfeit pharmaceutical
13.2 products as well as tracing the product all the
way to the end user, take appropriate
measures to avoid the misuse of holograms
and tampering actions

The sale and distribution of a suspected

counterfeit pharmaceutical product is
13.3
suspended and the national regulatory
authority notified without delay

Upon confirmation of the product being

counterfeit a formal decision is taken on its
13.4
disposal, ensuring that it does not re-enter
the market, and the decision recorded

Proposed Improvement
Actions

Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

13. Counterfeits Pharmaceutical Products Summary

# Of Conformities

2017 73 396479690.xls
# Of Non-Conformities

Strengths

Weaknesses

Action Plan
Action Deadline Result

2017 74 396479690.xls
2017 75 396479690.xls
2017 76 396479690.xls
 Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

Name & function of the referent

Name & function of personnel who participated in the self assessment

Meeting dates
Meet Requirement Comments
Guidelines (Note relevant information relating to the guideline, specifying the actions
Yes No undertaken or underway or planned to meet requirement)

14. Importation

At the port of entry, consignments of

pharmaceutical products are stored under
14.1
suitable conditions for as short a time as
possible

All reasonable steps are taken by importers

to ensure that products are not mishandled or
14.2
exposed to adverse storage conditions at
wharves, land fronts or airports.

Proposed Improvement
Actions

Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

14. Importation Summary
2017 77 396479690.xls
 Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation
14. Importation Summary

# Of Conformities

# Of Non-Conformities

Strengths

Weaknesses

Action Plan
Action Deadline Result

2017 78 396479690.xls
2017 79 396479690.xls
2017 80 396479690.xls
 Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

Name & function of the referent

Name & function of personnel who participated in the self assessment

Meeting dates
Meet Requirement Comments
Guidelines (Note relevant information relating to the guideline, specifying the actions
Yes No undertaken or underway or planned to meet requirement)

15. Contract Activities

Written contract exists for any activity within

the distribution of a pharmaceutical product
15.1
delegated to another authorized person or
entity

Contracts define the responsibilities of each

party and include responsibilities of the
contractor for measures to avoid the entry of
15.2
counterfeit medicines into the distribution
chain by suitable training programs

Audits are conducted on all contract

15.3 accepters at planned intervals to verify their
compliance in these guidelines

2017 81 396479690.xls
Proposed Improvement
Actions

Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

15. Contract Activities Summary

# Of Conformities

# Of Non-Conformities

Strengths

Weaknesses

Action Plan
Action Deadline Result

2017 82 396479690.xls
2017 83 396479690.xls
2017 84 396479690.xls
 Self-assessment & Evaluation of Good Distribution & Sto

Name & function of the referent

Name & function of personnel who participated in the self assessment

Meeting dates
Meet Requirement
Guidelines
Yes No

16. Internal quality audit

Internal audits at planned intervals are

conducted to the requirements of the GSDP
16.1 guidelines and to the quality management
system requirements established by the
warehouse

Internal audits are planned taking into

consideration the status and importance of
16.2
the operations and areas to be inspected, as
well as the results of previous audits

Internal audit criteria, scope, frequency and

16.3
methods are determined

Internal auditors and conduct of internal

16.4 audits ensure objectivity and impartiality of
the audit process

Responsibilities and requirements for

planning and conducting internal audits,
16.5
establishing records and reporting results are
written in a procedure
 Results of all internal audits are recorded

Reports contain all observations made during

16.6 the audit and, where applicable, proposals
for corrective measures

Management evaluate the internal audit

report and the records of any corrective
actions taken

Proposed Improvement
Actions

Self-assessment & Evaluation of Good Distribution & Storage Prac

16. Internal quality audit Summary

# Of Conformities

# Of Non-Conformities

Strengths

Weaknesses

Action Plan
Action Deadline
Distribution & Storage Practices Implementation

Comments
(Note relevant information relating to the guideline, specifying the actions
undertaken or underway or planned to meet requirement)
 on & Storage Practices Implementation
udit Summary

n
Result
 Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

Name & function of the referent

Name & function of personnel who participated in the self assessment

Meeting dates
Meet Requirement Comments
Guidelines (Note relevant information relating to the guideline, specifying the actions
Yes No undertaken or underway or planned to meet requirement)

17. Self-inspections

Self-assessments are conducted at planned

intervals to determine whether the quality
system conforms to planned arrangements, to
17.1
the requirements of the GSDP guidelines and
to the quality management system
requirements established by the warehouse

Selection of inspectors and conduct of

inspections ensures objectivity and
impartiality of the inspection process

Self-inspection criteria, scope, frequency and

17.2
methods are determined

2017 93 396479690.xls
 17.2

Self-inspections are planned taking into

consideration the status and importance of
the processes and areas to be inspected, as
well as the results of previous inspections

Results of all self-inspections are recorded

on the latest version of the self-assessment
sheets available on the Lebanese Ministry of
Public Health website (www.moph.gov.lb).

Reports contains all observations made

17.3 during the inspection and, where applicable,
proposals for corrective measures

An effective follow-up program exists and

Management evaluates the inspection report
and the records of any corrective actions
taken

Proposed Improvement
Actions

Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

17. Self-Inspections Summary

# Of Conformities

2017 94 396479690.xls
# Of Non-Conformities

Strengths

Weaknesses

Action Plan
Action Deadline Result

2017 95 396479690.xls
2017 96 396479690.xls
2017 97 396479690.xls
 Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

Name & function of the referent

Name & function of personnel who participated in the self assessment

Meeting dates
Meet Requirement Comments
Guidelines (Note relevant information relating to the guideline, specifying the actions
Yes No undertaken or underway or planned to meet requirement)

18. Measurement, Analysis and Improvement

The warehouse evaluate the performance and

the effectiveness of the quality management
system and retain appropriate documented
information as evidence of the results
- What needs to be monitored and measured
- The methods for monitoring, measurement
18.1 analysis and evaluation needed to ensure
valid results
- When the monitoring and measuring shall
be performed
- When the results from monitoring and
measurement shall be analyzed and
evaluated

2017 98 396479690.xls
 The warehouse applies suitable methods for
monitoring and where applicable,
measurement of the quality management
system processes
18.2
These methods demonstrates the ability of
the processes to achieve planned results.
When planned results are not achieved,
correction and corrective action shall be
taken, as appropriate

Proposed Improvement
Actions

Self-assessment & Evaluation of Good Distribution & Storage Practices Implementation

18. Measurement Analysis & Improvement Summary

# Of Conformities

# Of Non-Conformities

Strengths

2017 99 396479690.xls
Weaknesses

Action Plan
Action Deadline Result

2017 100 396479690.xls

2017 101 396479690.xls
 Self-assessment & Evaluation of Good Distribution & Sto

Name & function of the referent

Name & function of personnel who participated in the self assessment

Meeting dates
Meet Requirement
Guidelines
Yes No

19.Going green

3Rs practice, for Re-use, Reduce and

Recycle is adopted
19.1
Environmental practices are implemented
and up to date

The warehouse engage and involve

19.2
employees in its environmental approaches

Digital where possible to save paper

Energy saving, waste management and

recycling program are implemented
19.3

Awareness among employees is promoted to

ensure proper implementation of the
programs

Proposed Improvement
Actions

Self-assessment & Evaluation of Good Distribution & Storage Prac

19.Going green Summary
# Of Conformities

# Of Non-Conformities

Strengths

Weaknesses

Action Plan
Action Deadline
Distribution & Storage Practices Implementation

Comments
(Note relevant information relating to the guideline, specifying the actions
undertaken or underway or planned to meet requirement)

on & Storage Practices Implementation

ummary
n
Result