Logo Document No: xxx

ORGANIZATION NAME Approved date:

Effective date:
Title: Standard Operating Procedure for Self-Inspection Revision No. 00 Page 1 of 18

Title: Standard Operating Procedure for Self-inspection Logo

Status: SOP No.

Prepared by Approved by Revised by Version No.

Name: Name Name Effective date:

Sig: Sig: Sig: Review date:

Date: Date: Date: Supersedes:

Disclaimer: This is a model standard operating procedure. It incorporates generic guidance

principles only. Firms are encouraged to adapt their own SOPs as necessary to suit their in-
house procedures.

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Table of Contents

1. Introduction ................................................................................................................... 3
2. Purpose .......................................................................................................................... 3
3. Scope ............................................................................................................................. 3
4. Acronyms and Abbreviations ......................................................................................... 3
5. Definition....................................................................................................................... 3
6. Responsibility: ............................................................................................................... 4
7. Material and equipment:................................................................................................. 4
8. Procedure ....................................................................................................................... 5
9. Distribution .................................................................................................................... 6
10. Revision history.......................................................................................................... 6
11. References: ................................................................................................................. 6
12. Annexes ..................................................................................................................... 7

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1. Introduction:
Pharmaceutical company conducts self - audit periodically, in accordance with a
predetermined schedule and an internal procedure, internal audits to verify that its operations
continue to comply with the requirements of the management system.

2. Purpose:
The purpose of this SOP is to lay down procedures to conduct self- inspection (Internal-audit)
to monitor the implementation and compliance with good distribution and storage practices,
principles and to propose necessary corrective measures.

3. Scope:
This SOP applies to conduct self -inspection of good storage, transport and distribution
practices of medical products.

4. Acronyms and Abbreviations

CAPA Corrective and preventive action
EFMHACA Ethiopian Food, Medicine and Healthcare Administration and Control
Authority
GDP Good Distribution practice
GSP Good storage practice
QA Quality assurance
SOP Standard Operating Procedures

5. Definition
 Audit Means a systematic and independent examination to determine whether quality
activities and related results comply with planned arrangements and whether these
arrangements are implemented effectively and are suitable to achieve objectives. When
addressing the regulatory requirements, the term 'inspection' has been used to indicate
the same meaning as the term 'audit'.
 Auditee means any organisation whose quality systems are to be audited for
compliance with the relevant regulatory requirements.
 Auditor means a person with relevant qualifications and competence to perform audits
or specified parts of such audits and who belongs to or is authorised by the auditing
organisation.

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 Lead auditor means an auditor designated to manage an audit process (also known as
an audit team leader).
 Minor deviation means deviation from standard operating procedure or guidelines
which cannot lead to what is described under major or critical
 Major deviation means any deviation from the established procedure, process, system
and practice
 Critical deviation means critical point is any non-conformance, which can affect the
purity, strength and safety of the medicines, which pose serious health risk to the users.

6. Responsibility:

6.1. Head- Quality assurance/quality manager/Technical manager shall be:

6.1.1. Responsible to establish audit team
6.1.2. Responsible for approval of annual calendar for internal audit
6.1.3. Responsible for ensuring the conduction of internal audit as per schedule
6.1.4. Responsible for review and approval of summary report of internal audit report.

6.2. The audit Team shall be:

6.2.1. Responsible for conducting the audit as per schedule.
6.2.2. Responsible for checking the compliance of observations made during previous
audit
6.2.3. Responsible for preparation of internal audit report
6.3. The Auditee shall be:
6.3.1. Responsible for implementing the corrective action recommendation by audit team
6.3.2. Responsible for preparation of audit compliance report
6.3.3. Responsible to coordinate auditors and provide required information
7. Material and equipment:
 Stationary materials
 Checklists
 Previous audit report/external audit report/customer audit report
 National GDP and GSP guidelines and/or international recognized guidelines

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8. Procedure
8.1. Annual calendar for internal audit will be prepared by [Quality assurance/ technical
manager] and approved by responsible head (Refer Annexure-1)
8.2. During Internal audit, check compliance level of audits done by any external agency or
regulatory body and access the compliance level of audit carried by customers
8.3. Apart from annual calendar, audits may be carried out when there are any failure/
compliant/recall/regulatory findings etc.
8.4. The list of auditors (Annexure-2) will be prepared from different departments
considering members from cross functional area with no conflict of interest.
8.5. Internal auditors shall be selected by quality assurance/quality manager/Technical
manager based on his/her experience, qualification, subject matter expertise and
knowledge.
8.6. Each area shall be audited/ inspected at least once in six months.
8.7. The parameters to be covered shall include at least good storage practice, good
distribution practice, quality management system, personnel etc.
8.8. The audit scope may be narrowed down to cover only a particular segment/activity as
needed.
8.9. The auditors jointly inspect the respective areas as per checklist as applicable
8.10. Auditors shall verify data integrity related issues of each department as applicable
8.11. The observations may not be limited to the checklist. It can be extended towards the
criticality of findings.
8.12. The auditor report will be agreed on findings based on factual evidence necessary to
record all the observation in audit report.
8.13. The deficiencies observed during audit shall be categorized as Critical. Major, Minor
(other) deficiencies.
8.14. Based on the observations in the audit, the auditor shall prepare the separate audit
report as per the format given in annexure I and send a copy to the auditee [within
agreed working days] of audit date.
8.15. A copy of audit report shall be submitted to [Head of Quality assurance/Technical
manager] depending on the size of the organization. The audited department shall send
their CAPA plan within 15 days after receipt of audit report.
8.16. Follow up will be organized after the execution of CAPA.

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8.17. Audit report and compliance report should be available for regulatory review.
9. Distribution
This SOP should be distributed to
 Technical managing office
 Warehouse manger
 Quality assurance department or General managing office
 To other necessary departments

10. Revision history

Revision number Summary of change Effective date
R0 New SOP To be assigned
R1
R2

11. References:
1. Ethiopian Food, Medicine and Health Care Administration and Control Authority,
Good Storage, Distribution and Pharmaceutical Recall guideline, 2014
2. World Health Organization: Good Storage Practice Guidelines

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12. Annexes
Annexure 1: Annual Calendar Format for Internal Audit
SN Department Jan Feb mar App may June July Aug Sep Oct Nov Dec
1. Warehouses
2. Distribution
and delivery
4. Procurement

Annexure 2: Format for list of Auditors

SN Name of auditors Department Name and department for audit

1.
2.
3.

Annexure 3: Format For Audit Report and Compliance report

Date of inspection: __________________________

Members of inspection team: __________________
Auditee department: _________________________
Reason for self-audit: ________________________
Status of Previous self-inspection: _________________________________________
SN Observation Category (Critical, Major and Other)

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Annexure 4: Corrective and preventive action plan for self-inspection

Department: ________________________________

Focal person: _______________________________

SN Category Observations Proposed Indicator for Proposed Status

CAPA accomplishment closing date (closed or
pending)

Annexure 5: Checklist for premises & Facilities, and Sanitation & hygiene

SN Premises and Facilities

1. Unauthorized access to all areas of the authorized premises is prevented In NC NA
2. Receiving and dispatch bays protect products from prevailing weather
conditions
3. Segregated areas are designated for the storage of any product suspected
of falsification, returned product, rejected product, product awaiting
disposal, recalled product
4. Radioactive materials other hazardous products and products presenting
special risks of fire or explosion are stored in a dedicated area(s) with
appropriate safety and security measures
5. There is adequate separation between the receipt and dispatch areas and
storage areas
6. Rest, wash and refreshment rooms for employees are adequately
separated from the storage areas
7. Is there receiving SOP and there check list that should be filled during
receiving of products, is record maintained
8. Is there approved supplier list
9. Is there Dispatch SOP and there check list that should be filled during
dispatching of products, is record maintained
Sanitation and Hygiene

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1. Procedures relating to personnel hygiene like health, hygiene and

clothing are
established and observed
2. Storage of food, drink, smoking materials or medication for personal use
in the storage areas is prohibited
3. Cleaning instructions and records are in place
4, Facilities are designed and equipped so as to afford protection against the
entry of insects, rodents or other animals
5, A preventive pest control programme is in place

Annexure 6: Checklist for temperature & environmental monitoring and equipment &
computer system

SN Temperature and environmental control In NC NA

1. Suitable equipment and procedures are in place to ensure adequate
control of the environment
2. Storage areas are temperature mapped for all seasons
3. Temperature monitoring equipment is located according to the results of
the mapping exercise
4. Controls are adequate to maintain all parts of the relevant storage area
within defined temperature, humidity or light parameters
5 Equipment used to control or to monitor the environment, are calibrated
and their correct operation and suitability is verified at defined intervals
by the appropriate methodology
6 Appropriate alarm systems are in place to provide alerts when there are
deviations from pre- defined storage conditions
7 Alarms are regularly tested
8 Power back generator or other means
Equipment and computer systems
1 Planned preventive maintenance is in place for key equipment
2 Calibration of equipment is traceable to a primary standard
3 Adequate records of repair, maintenance and calibration activities for

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key equipment is made and the results are retained

4 Detailed written descriptions of the systems are available (describing the
principles, objectives, security measures and scope of the system and the
main features, how the computerized system is used and the way it
interacts with other systems
5 Data is entered into the computerized system or amended only by
persons authorized to do so
6 Data is secured by physical or electronic means against wilful or
accidental damage
7 Data is protected by backing up at regular intervals

Annexure 7: Checklist for Documentation, records, supplier & customer qualification

and Receipt of Goods

SN Documentations IN OUT NA
1. Documents are/ is retained for a period stated in national legislation
but at least for five years at a separate, secure location
Standard Operating Procedures
2. SOPs are reviewed regularly and kept up-to-date
3. SOPs are approved, signed and dated by appropriate authorized
persons
4. Superseded or obsolete SOPs are removed from workstations
Records
5. For any transaction in medicinal products received, supplied or
brokered, records are kept either in the form of purchase/sales
invoices, delivery slips, or on computer or in any other form
6. Records include the following information:
 Date
 name of the medicinal product
 quantity received, supplied or brokered
 name and address of the supplier, broker or consignee, as
appropriate

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 batch number where required

7. Distribution records contain sufficient information on distributors and
directly supplied customers (with addresses, phone and/or fax
numbers inside and outside working hours, batches and quantities
delivered), including those for exported products and medicinal
product samples
Distribution Operation /supply chain operation
8. All medicinal products distributed in Ethiopia have a marketing
authorization/ Waiver granted by the EFMHACA
9. Supplier Qualification
10. All supplies of medicinal products are obtained only from persons/
organizations who are in possession of an import/ wholesale
distribution authorization, or who are in possession of a
manufacturing authorization which covers the product in question
11. The purchase of medicinal products is controlled by written
procedures
12. The supply chain of medicinal products/pedigree is known and
documented
13. Appropriate qualification is performed prior to any procurement
14. Qualification and approval of suppliers is controlled by a standard
operating procedure
15. The results of qualification and approval of suppliers are
periodically rechecked
Qualification of Customers
16. Medicinal products are only supplied to persons/organizations who
are themselves in possession of a distribution authorization or who
are authorized or entitled to supply medicinal products to the public
17. Qualification of customers and periodic re-checks include:
 Requesting copies of customer's authorizations
 Verifying status on an authority website
 Requesting evidence of qualifications or entitlement according to

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national legislation.
 Qualification of customers are appropriately documented
 Additional Questions which might be asked for verification:
Receipts of Goods
18. Ensured that the arriving consignment is correct, the medicinal
products originate from approved suppliers and have not been
damaged or altered during transportation
19. Medicinal products which require special storage or security
measures, are transferred to appropriate storage facilities
immediately after appropriate checks have been conducted
20. In the event of any suspicion of falsified medicinal product, the
batch is immediately segregated
21. In the event of any suspicion of falsified medicinal product, the
batch is immediately reported to the EFMHACA
22. In the event of any suspicion of falsified medicinal product, the
batch is immediately reported to the marketing authorization holder
(where applicable)
Incoming containers of medicinal products are cleaned, if necessary,
before storage.

Annexure 8: Checklist for inspection Storage and Distribution Practice

SN Storage IN NC NA

1. Medicinal products are stored separately from other products

2. Medicinal products are protected from harmful effects of light,
temperature, moisture or other external factors.
3. Attention is paid to products where specific storage conditions are
required
4. Stock rotation according to the expiry dates of batches of medicinal
products is performed ("first expired first out" –FEFO- basis.)
5. Medicinal products beyond their expiry date or shelf life are withdrawn
immediately from saleable stock either physically or through other

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equivalent electronic segregation.

6. Physical removal of unsuitable stock is performed regularly
7. Medicinal products are not stored directly on the floor.
8. Stock inventories are performed regularly (timings are defined using a
risk based approach)
9. Inventory irregularities are investigated and documented
10. Medicinal products are stored separately from other products
Segregation of Goods
11. Segregation is provided for the storage of rejected, expired, recalled or
returned products and suspected falsified medicinal products.
12. Any system replacing physical segregation such as electronic segregation
based on a computerized system provides equivalent security and is
validated
Destruction of obsolete goods
13. Medicinal products intended to be destroyed are kept separately and
handled in accordance with a written procedure.
14. Destruction of medicinal products is in accordance with EFMHACA
disposal guidelines and/ or international requirements for disposal of
such products
15. Records of all destroyed medicinal products are maintained
Complaints IN NC NA
16. A written procedure is in place for the handling of complaints
17. In the case of a complaint about the quality of a medicinal product, the
manufacturer and/or marketing authorization holder is informed without
delay
18. A person is appointed for handling the complaints with sufficient
supporting personnel
19. Any complaint concerning a potential product defect or a potential
falsified product is recorded with all the original details and investigated
20. The national competent authority is notified without delay in case of a
potential product defect or a potential falsified product

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21. Any product distribution complaint is thoroughly investigated and

appropriate follow-up actions are taken after investigation and evaluation
of the complaint
Returned Medicinal Products
22. Written procedures are in place for the handling and acceptance of
returned
23. Medicinal products which have left the premises of the distributor are only returned
medicinal products to saleable stock if:
 The medicinal products are in their unopened and undamaged
secondary packaging and in good condition
 Demonstrated that the medicinal products have been transported,
stored and handled under proper specified/predefined conditions
 The distributor has reasonable evidence that the product was supplied
to that customer
 The batch number of the dispatched product is known
 A copy of the original delivery note is attached
 There is no reason to believe that the product has been falsified
 There is evidence that the product has been stored within the
authorized storage conditions throughout the entire time
 A risk assessment is performed by taking into account the product
concerned, any specific storage requirements and the time elapsed
since the medicinal product was originally dispatched
Suspected falsified medicinal products
24. The staff is aware of the risks of falsified medicinal products entering the
supply chain
25. A procedure is in place describing immediate information to
EFMHACA/regional regulatory bodies and, where applicable, the
marketing authorisation holder of the medicinal products they identify as
falsified or suspect to be falsified
26. Any suspected falsified medicinal products found in the supply chain is
immediately physically and securely segregated from legitimate medicinal

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products
27. Record available when there is suspecsion
Medicinal Product Recalls
28. There is a written procedure for the management of recalls
29. The management of recalls and its effectiveness is periodically tested and
evaluated by Mock Recall
30. Any recall operation is recorded at the time it is carried out
Transportation
Vehicles and equipment
31. Required storage conditions are maintained during transportation
32. Vehicles and equipment are suitable and appropriately equipped to prevent
exposure of the products to conditions that could affect their quality and
packaging integrity, and to prevent contamination of any kind
33. Procedures are in place for the operation and maintenance of all vehicles
and equipment, including cleaning and safety precautions
34. Validated temperature-control systems (e.g. thermal packaging,
temperature controlled containers, and refrigerated vehicles) are used to
ensure correct transport conditions
35. If refrigerated vehicles are used temperature mapping is performed under
representative conditions including seasonal variations
36. Equipment used for temperature monitoring during transport within
vehicles and/or containers, is maintained and calibrated at regular intervals
at least once a year
37. If cool-packs are used in insulated boxes, they are located such that the
product does not come in direct contact with the cool-pack
38. If cool-packs are used in insulated boxes, staff is trained on the procedures
for assembly of the insulated boxes (seasonal configurations) and on the
reuse of cool-Packs.
Delivery
39. Delivery drivers (including contract drivers) are trained in the relevant
areas of GDP

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40. Deliveries are made directly to the address stated on the delivery note
41. Deliveries are handed into the care of the consignee.
42. Deliveries are not left on alternative premises
Deviations
43. Deviations are reported to the distributor and recipient
44. Where necessary in the case of deviations, the manufacturer of the
medicinal product is contacted for information about appropriate steps to
be taken
45. Container and packaging is selected based on:
 the storage and transportation requirements
 the space required for medicines
 the anticipated external temperature extremes
46. A document is enclosed to ascertain the following:
 Date
 Name and pharmaceutical form of the medicinal product
 Batch number at least for products bearing the safety features, where
required
 Quantity supplied
 Name and address of the supplier
 Name and delivery address of the consignee (actual physical storage
premises, if different)
 applicable transport and storage conditions
47. Containers bear labels providing sufficient information on handling and
storage requirements and precautions
48. Containers bear labels enable identification
49. Requirements laid down by the concerned member states are met
50. Transportation is performed in safe, dedicated and secure containers and
vehicles
Annexure 9: Checklist for Quality Management System and Personnel
SN Quality Management System In Out NA
1. Does the company have a written policy including management's active

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commitment to quality
2. Is the policy signed by top management
3. Is there an approved quality manual and written procedures describing all
related processes?
4. Do management reviews consider:
 Findings of internal audits, recommendations made and corrective
actions taken?
 The overall effectiveness of the system in achieving quality objectives?
 Opportunities for updating and/or improving the system?
5. Is there a copy of the manufacturers’ documents (such as COA or COC)
supplied with each delivery?
6. Is there procedure for corrective and preventive actions
7. Trend Reports of findings and recommendations from Regulatory
Inspection of the past 2 years
8. Certificate of Competency displayed and displayed Certificate of
Competency validity documentation of disposition of out dated products
maintained for 3 years
Personnel
9. Organizational structure of the distributor is defined in an organizational
chart.
10. The responsibility, role and interrelationships of all personnel is clearly
indicated
11. Responsibilities and roles of employees working in key positions is defined
in written job descriptions, incl. deputyship arrangements
12. All personnel involved in wholesale distribution activities is qualified in
GDP requirements
13. Training includes aspects of product identification and avoidance of
falsified medicines entering the supply chain
14. Specific training is provided where indicated (e.g. handling of hazardous
products, radioactive materials as well as products presenting special risks
of abuse, narcotics

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or psychotropic substances, or temperature sensitive products)

15. Personnel receives initial and continuing training relevant to their tasks,
based on written standard operating procedures (SOPs) according to a
written training
programme
16. The practical effectiveness of training is periodically assessed and
documented
17. Has the company a sufficient number of qualified employees for these
operations?
18. Are employee training and qualification records maintained?
19. Are there procedures in place ensuring good hygiene of the personnel
20. Proper Personnel Identification, ethical behaving and clothing

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