To develop a general understanding of what is required from the guidelines of Good Storage and

Distribution Practices of Pharmaceutical Products in Lebanon

To have an overview of the guidelines of Good Storage and Distribution Practices of Pharmaceutical

Products in Lebanon

MOPH – Good Storage & Distribution Practices – 2015 – Rev:01 2

Guidelines of Good Storage and Distribution Practices of Pharmaceutical Products in Lebanon

WHO good distribution practices for pharmaceutical products (WHO technical report series, No. 957,2010)

WHO guide to good storage practices for pharmaceuticals (WHO technical report series, No. 908, 2003)

Commission guidelines on good distribution practices of medicinal products for human use, Europeancommission, 2011

ISO 9001:2008, quality management systems requirements

2006دليل ممارسة التخزين والتوزيع الصيدالني الجيد دولة اإلمارات العربية المتحدة، وزارة الصحة، إدارة الرقابة الدوائية

2012مدونة أسس ممارسة التوزيع والتخزين الجيدة، المملكة العربية السعودية، الهيئة العامة للغذاء والدواء اً تعليمات شروط نقل األدوية وتوزيعها والمواصفات الفنية لوسائط نقل األدوية صادرة عن مدير عام المؤسسة العامة للغذاء والدواء إستناد

2001لسنة 80من قانون الدواء والصيدلة رقم 56إلى المادة

MOPH – Good Storage & Distribution Practices – 2015 – Rev:01 3

The Good Storage and Distribution Practices (GSDP) guidelines are issued, according to the guidelines and

instructions of the World Health Organization, by the Lebanese Ministry of Health to assist Drug

wholesale distributors in conducting their activities and maintaining a good quality control system.

Resolution #1637/2013 was issued by the Minister of Public Health in Lebanon to adopt the GSDP manual.

The implementation of these guidelines will help evaluate and improve the conditions of the Drugs wholesale

Storage and Distribution all through the supply chain.

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عملية ضمان الجودة، التي تضمن عبر رقابة كافية على

جميع األنشطة التي تحدث أثناء عملية التوزيع والتخزين

من المنتجات المزيفة، الغير موافق عليها، المستوردة بطريقة لحماية سلسلة التوزيعأداة أو المنتجات الصيدالنية دون المستوى المطلوب/ و غير مشروعة، المسروقة،

1. Organization and management

2. Personnel

3. Quality system

4. Premises, warehousing and storage

5. Vehicles and equipment

6. Shipment containers and container labeling

7. Dispatch and receipt

8. Transportation and products in transit

9. Documentation

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10. Repackaging and relabeling

11. Complaints

12. Recalls

13. Returned products

14. Counterfeit pharmaceutical products

15. Importation

16. Contract activities

17. Self-inspection

18. Measurement, analysis & improvement

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Guidelines

Meet Requirement Comments (Note relevant information relating to the

guideline, specifying the actions undertaken or underway or planned to meet requirement)

Yes No

1. ORGANIZATION AND MANAGEMENT

1.1

Organization chart defines responsibilities, authorities and interrelationships of all

personnel to assure processes for product selection and quality are not compromised

1.2

Duties and responsibilities are communicated and understood by concerned individuals through documented and reviewed job

descriptions

1.3

A qualified person, with the specificresponsibility and the appropriate authority to

deal with excipient related quality issueswithin the warehouse, is appointed to ensure

that a quality management system is implemented and maintained

1.4Management and personnel are not subject to

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

1.5The warehouse determines, provides and

maintains the infrastructure needed to achieve conformity to product requirements

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√x

الهيكل التنظيمي واإلداري

There should be an adequate organizational structure for each entity, defined with the aid of an

organizational chart that clearly identifies responsibilities, authorities and interrelationships of all

personnel.

Organizational chart

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Duties and responsibilities should be clearly defined through documented job descriptions and

understood by the concerned individuals, who should be trained on their respective duties and

responsibilities.

Job descriptions

Training evidence (training certificate, training attendance sheet)

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الموظفون

All personnel involved in the distribution activities should be competent on the basis of appropriate

education, training, skills and experience in the requirements of good distribution and storage practices.

Diploma, work attestations, others

Written standard operating procedures (SOPs)

Training evidence (training plan, training attendance sheet, training certificate, training evaluation)

كفاءةالتدريبالتعليم

Personnel training should be based on written standard operating procedures (SOPs).

They should receive initial and continuing training, in accordance with a written training program and they

should be assessed to evaluate the effectiveness of the actions taken.

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Codes of practice and punitive procedures should be in place to prevent and address situations where

persons involved in the distribution of pharmaceutical products are suspected of, or found to be implicated in,

any activities relating to the misappropriation, tampering, diversion or counterfeiting of any product.

Procedures for disciplinary actions

اإلجراءات التأديبية

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نظام الجودة

There should be a documented quality policy describing the overall intentions and requirements of the

distributor regarding quality, and including a commitment to comply with those requirements and continually

improve the effectiveness of the quality system, as formally expressed and authorized by management.

Quality policy We are committed to the distribution and storage of pharmaceutical products preserved in their integrity and quality in order to contribute to the health and well being of the community.

This will be achieved by the implementation andcompliance to the Good Distribution & StoragePractices guidelines.

We will continuously improve our processes andalways deliver reliable quality in our products andservices with the aim to be one of the leadingpharmaceutical companies in the country.

اإللتزام اإلداري

التعهد بالتطور المستمر

وسيلة إلعالم األطراف المعنية

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Inspection, auditing and certification of compliance with a quality system (such as the applicable

International Standardization Organization (ISO) series, or national or international guidelines) by external

bodies is recommended.

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مواقع التخزين،األجهزة و وسائل النقل

Precautions must be taken to prevent unauthorized persons from entering storage areas.

Storage areas should be of sufficient capacity to allow the orderly storage of the various categories of

pharmaceutical products, namely commercial and non-commercial products, products in quarantine, and

released, rejected, returned or recalled products as well as those suspected to be counterfeits. .

Storage map / zoning

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Organizations in charge of distribution must ensure that premises and storage areas undergo regularly a

pest control program or must ensure that pest control activities are subcontracted to a specialized entity

followed up regularly.

Contract with outsourced pest control company

Pest control program up to date

Material data sheets of pesticides

Pest control map

On site identification and control of baits

Procedure for reporting incidents and following up corrective actions

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If sampling is performed in the storage area, it should be conducted in such a way as to prevent

contamination or cross-contamination. Adequate cleaning procedures should be in place for the sampling

areas.

Written sampling procedure

Sampling plan

Cleaning procedures

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Receiving and dispatch bays should protect pharmaceutical products from the weather. Receiving areas

should be designed and equipped to allow incoming containers of pharmaceutical products to be cleaned, if

necessary, before storage.

منطقة اإلستالم والتسليم

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Records of temperature and humidity monitoring data should be available for review. Temperature

mapping should show uniformity.

Procedure for temperature and humidity mapping

• Warehouse has been temperature mapped and an adequate number of monitoring devices are

located throughout the facility

Temperature & humidity monitoring log sheet

Monitoring plan of measuring devices

Records kept for a duration = at least the shelf-life of the stored pharmaceutical product + 1

The equipment used for monitoring should be checked at suitable predetermined intervals.

There should be defined intervals for checking temperature.

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التوثيق

Procedures should be established and maintained for the preparation, review, approval, use of and

control of changes to all documents relating to the distribution process. Procedures must be in place for both

internally generated documents and those from external sources.

Control of documents procedure

Documents, and in particular instructions and procedures relating to any activity that could have an

impact on the quality of pharmaceutical products, should be designed, completed, reviewed and distributed

with care.

Diffusion and records matrix

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الشكاوى

There should be a written procedure in place for the handling of complaints.

Inform the original manufacturer and/ or

marketing authorization holder

Written procedure for handling of complaints

عبوتهالمستحضر أو جودة التوزيع

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االستدعاءات

There should be a system, which includes a written procedure, to effectively and promptly recall

pharmaceutical products known or suspected to be defective or counterfeit, with a designated person(s)

responsible for recalls.

Written procedure for recalls

The original manufacturer and/or marketing

authorization holder should be informed in the event

of a recall

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البضائع المسترجعة

A distributor should receive pharmaceutical product returns or exchanges pursuant to the terms and

conditions of the agreement between the distributor and the recipient.

Both distributors and recipients should be accountable and

should ensure that the aspects of this operation are secured

and do not permit the entry of counterfeit products.

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التفتيش الذاتي

The quality system should include self-inspections. These should be conducted to monitor

implementation and compliance with the principles of GDP.

Self-inspections should be conducted

in an independent and detailed way by a

designated, competent person.

Written procedure for self-inspections

Proof of competence of designated inspector

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القياس والتحليل والتحسين

As one of the measurements of the performance of the quality management system, the warehouse

should monitor information relating to customer perception as to whether the customer requirements are met.

The methods for obtaining and using this information shall be determined.

Documented dashboard with relative KPIs

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