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Syrian Ministry Of Health
 
   
   
Directorate of Laboratories and Research, Oversight pharmaceutical

Introduction

Directorate is committed to control and research laboratories in the pharmaceutical application of laboratory quality control program at all stages of its work, as always seeks to develop in line with global developments in this area has received the ISO Directorate / 1994 ISO 9002 has been amended on 26.8.1999 the certificate and the transition to the new specification ISO 9001/2000 dated 11/10/2001 and ISO ISO 14001 environment is also being done to comply with the rehabilitation of safety ISO 18000 and ISO quality of laboratory work ISO 17025. This in turn contributes to constantly improve to the highest level excellence in quality management, which ensures the implementation of the highest quality analysis and more accurate and faster. The application of quality standards contribute to cooperation and exchange of expertise between laboratories and scientific bodies concerned, which makes it work is by and harmony according to the approved specifications and agreed upon in advance in this area. Until then optimally has been supplementing the Directorate of modern equipment and accurate calibration, which has been verified credibility and validity of work and cadre of qualified and trained technical and professional supplier of high morale, and specific tasks and following up by management and share in planning and carry out the tasks and responsibility and establish continuous improvement as a basis for improving performance, which ensures quality, effectiveness and safety of the drug at the best international standards.

Location
1. Adawi, Damascus - Building the Mediterranean Institute of Health's sixth floor and part of the fifth floor.
2. Damascus - Kafar Souseh - Laboratories Directorate building in Kafar Souseh the basement and first and second floors.
3. Warehouses Directorate in Ibn al-Nafis dependency: the Central Administration of the Ministry of Health - Associate Minister of Health for the drug. Key actors: - Monitoring and quality control of pharmaceuticals and medical supplies

Control functions of the Directorate Laboratories and Pharmaceutical Research

Directorate has been developed to become an informant laboratories leading reference both nationally and internationally in the field of drug control laboratory is equipped laboratories where specialized equipment and advanced automated complex which provides services in quality control of medicines available in the market, including imported and locally manufactured.

Of the main tasks of the Directorate and committees that represent where they contribute to all activities of monitoring and inspection and pharmaceutical control in Syria, which, among them:.
1. Good manufacturing the drug GMP.
2. Good for the distribution of the drug GLP.
3. Good Laboratory Practices GLP.
4. Good pharmacy practice GPP.
5. Good clinical practices GCP.

Analysis of samples from the following pharmaceutical factions received by the Directorate from various sources:
1. License
2. First
3. Second
4. Heart
5. Psychological
6. Hormonal
7. Prepared for glaucoma (Ambuhl, Vial and Seromat).
8. Export
9. Drops in kind.
10. Complaint
11. Further to the record.
12. Requests from others.
13. Random.
14. Before and after discussion the freeze.
15. Clinical
16. Bio-availability.
17. Tenders

A qualitative analysis of the complex equipment such as:
1. Participation in decision-making concerning the registration of pharmaceuticals for human use and the issuance of certificates of analysis.
2. Cooperation with international bodies and institutions such as the Council of Europe (the European Pharmacopoeia) and the World Health Organization and the Global Foundation for Technical Cooperation.
3. Study and evaluate the log files botanical medicine in terms of stability studies, availability and bioequivalence.
4. Contribute to improving the quality of medicines Dit requirements, which include specifications, tests and the necessary equipment.
5. Contribute to the professional program of quality control tests on Advanced Pharmaceutical which gives the global reputation and credibility to the Directorate.
6. Specialized training in the Drug Control Laboratory to residents of the jurisdiction of the control and the pharmaceutical industry
7. To provide and update the requirements analysis of materials and equipment, references and technical staff.
8. Participate in seminars, conferences and relevant scientific bodies and establishing local and international exchange of scientific studies and participation tests professional world.
9. Upgrading the scientific and technical and technical support to the Directorate of Lima in line with global requirements of good laboratory practices and quality.
10. Participation in the specialized drug-related.
11. Audit data for addressing drug resistance in the first stage Althouderp and conformity of the data that have been approved in the stage of the license file: include (inner and outer containers - Bulletin).
12. Archive certificates of laboratory analysis of pharmaceutical and authentication certificates of analysis for export or register externally.

Provide services to the pharmaceutical industry

Provide services to the pharmaceutical industry, including reference materials necessary for the analysis of chemicals or reagents or plans of qualitative analysis and stability studies and bioequivalence code or bacterial and training seminars and so on.

Quality control in the Department of laboratories and Pharmaceutical Research

Growing importance of the role of analytical tests in the strength and credibility of the economies of all countries and with the globalization of trade is increasingly the emphasis on quality of life through attention to issues relating to environment and health and safety. That the validity and credibility of the analytical results of the tests I have regard for both producers and customers benefit from the results and data analysis.

Policy and objectives of the Program Quality Control

Program aims at quality control investigation of the correctness and accuracy of the results of laboratory tests. The primary responsibility for quality control policy to senior management of the Directorate, which sets out the objectives and the policy of quality control as an outline and secure the resources necessary to verify that the program of quality control is according to the objectives laid down in the Quality Manual. Manual provides total quality control requirements for quality control in the overall concept, which includes standard operating plans, which in turn provide the quality control requirements for each section. It also contains the largest amount of detail documenting the total processes of different laboratory. Stakeholders are informed to this quality, which must be read by those actors then each factor in the laboratory to read and understand the tasks entrusted to him and accept to do it and sign it and adhere to the implementation of its prerogative to implement the program of quality control. And each worker to read and understand the standard operating plans (SOP) pertaining to his work in the laboratory. Is the responsibility of senior management to ensure that quality control and guide all action plans are the standard of application and relays that can be made on these documents had been read and understood by all employees each according to its competence and its work.

Directorate of Laboratories and consists of control and pharmaceutical research laboratories of the following:
1. Physical Laboratory of Drug Control
2. Pharmaceutical Control Laboratory of chemotherapy.
3. Laboratory analysis of the mechanism
4. Laboratory of Bacterial Drug Control.
5. Laboratory of Drug Control pharmacological (Division of the impact of pharmaceutical laboratories), followed by Breeding laboratory animals.
6. Laboratory studies of stability.
7. Laboratory studies of availability and bioequivalence of the medicine.
8. Administrative office, secretarial and documentation.
9. Quality Assurance.

Quality Control Section

The effectiveness of good laboratory practices are for the control of the Directorate of Laboratories and Pharmaceutical Research. The Directorate has been participating in the inspection of all the national laboratories and pharmaceutical laboratories, which must also be scrutinized by the ISO systems, as well as through participation programs of quality control of drugs of the European Union and the World Health Organization

Examinations conducted at the Laboratory of Drug Control of the physical
1. Density.
2. The solubility.
3. Molecular weight.
4. Refraction.
5. Polarization
6. Viscosity
7. Surface tension.
8. Varying weight.
9. Homogeneity of content.
10. Crumbling.
11. Degenerative

Examinations conducted at the Laboratory of Drug Control Chemical
1. Qualitative tests.
2. Quantitative tests.
3. Adjustments acid - basis.
4. The exchange of electrolytes and gel filtration.
5. Adjustments anhydrous.
6. Adjustments of oxidative stress and return.
7. Adjustments weighted.
8. Analysis of complexes.
9. Methods of extraction solution.
10. Adjustments for all pharmaceutical forms.

Tests conducted in laboratory analysis mechanism on the following devices
1. Differentiate liquid chromatography.
2. Differentiation gas chromatography.
3. To differentiate the thin-layer chromatography.
4. Teams latency.
5. Carl Fischer to calibrate the humidity.
6. Measuring absorption of ultraviolet radiation and visible.
7. X-ray absorptiometry red underneath.
8. Absorptiometry fluorination.
9. Study the characteristics of raw materials.
10. Measure of the flame.
11. Standard atomic absorption
12. Mass spectrometry device.

Examinations conducted at the Laboratory of Bacterial Drug Control
1. Sterility test.
2. Calibration methods of bacterial antibiotics.
3. Purity tests, and bacterial contamination.
4. Microbial diagnostic tests.
5. Preparation of the agriculture and validated.
6. Junta bacterial multiplication, storage and security Junta pure from global sources
7. Secure evidence standard required.

Tests carried out in laboratory control the impact of medicines (Medicines Control Laboratory of Pharmacology)
1. Testing among generators of heat.
2. Calibration tests Alseromat.
3. Acute toxicity tests and tests the safety of drugs.
4. Calibration of hormones and compounds Aldegtal.
5. Calibration of insulin.
6. Alaoxi calibration Toussaint.
7. Assays medicine leverage to pressure and of antihypertensive medications.
8. Calibration drugs heparin.
9. Calibration of protamine sulfate.

Tests conducted in laboratory animal husbandry lab

The section ensure the necessary laboratory animals from mice, rats, rabbits and large animals such as cats and dogs. As well as overseeing the breeding and preservation of its cleanliness and safety of diseases as well as securing all the necessary feed and accessories, cages and stone rooms and equipment as well as keeping records of those particular animals.

Aalachtbarat that are at the Laboratory of stability studies

The section of laboratory tests carried out to ensure the quality of pharmaceutical raw materials and finished pharmaceutical products and by this division to conduct stability studies from the viewpoint of quality control of pharmaceutical code that are being planned in accordance with the protocols of this section shall also coordinate the results of studies and documentation, print, and secure the reagents and accessories work.

Tests carried out in laboratory studies of availability and bioequivalence of medicines

This section of laboratory tests conducted in the field of studies testing the availability and bioequivalence from the viewpoint of Illtjawdp. In order to verify the conformity of the specifications of pharmaceutical pharmaceutical world is that Bijraachtbarat Bioequivalence glass and include the verification tests of physical and chemical properties to ensure that drug does not change Bonalmsthoudrat specifications of the preparations for that or other similar pharmaceutical products in the installation and available in the market are effective and specifications are similar and include tests bioequivalence between pharmaceutical Almatipwalfalip testing, quality, purity and homogeneity and the caliber of content and time of general collapse and degenerative and after the testing mentioned above for equal dynamic in vitro tests conducted after the availability and bioequivalence in an organism, according to specific protocols

The administrative office and secretarial and documentation

This section would all work related to laboratory monitoring and pharmaceutical research and organization of the archives for workers and the organization of warehouses and committees procurement and inventory, emergencies and the annual printing and receipt of samples and delivery of results and receive mail, format, and translation.

Department of Information Technology
1. Sophisticated systems and is updated periodically on receipt of each medication based on the program information
2. A comprehensive program for all actors in the Directorate.
3. A special program warehousing.
4. Is to use the software and e-mail and the Internet.
5. Are developing software to link all departments of medicine information network among themselves.

Technical staff

All technical staff, which has a direct relationship with risk analysis and the results were released staff is trained and experienced and high efficiency an average of almost ten years of experience with the implementation of a training program for employees according to the following: mandatory training - Continuous training - internship - English courses - programming cycles.

Training courses and training programs for workers
1. Mandatory training: All new employees are subject to training courses and guidance on safety at work and fire protection and that each worker record of qualifying and training records of all training courses followed by the Group.
2. Ongoing training: to be applied internally and externally through participation in specialized workshops and seminars and so on. .
3. Internship: where there's a training plan for each section throughout the year. .
4. English language courses: The following training courses in English for 50 Technician in 2003. .
5. Software (Win-Word-Excel-Access): 60 were trained technician in 2003

Quality of existing equipment in the Directorate

Maintenance is to maintain a record system and all hardware, which includes preventive maintenance of problems at work, Hang, reform in the department, the company's suppliers. The information includes history, describing the action that has been or corrective actions with an explanation of any problem. Is calibrated in all devices that affect quality, internally or externally depending on the type of device. The seizures are documented in the book and calibration device in the paper records.

Laboratory equipment
1. ( 6 ) UV-Visible Spectroscopy(2) IR- spectroscopy
2. Fluorometry (2) DSC (Differential Scanning Calorometry) Chromatography. TLC spotter + TLC Scanner (10) HPLC
3. Column Chromatography (3) GC GC - MS
4. Paper Chromatography Viscosity
5. Refractive Index. Autotitrator
6. Karl - Fisher.*
7. Density
8. Dissolution
9. Disintegration  
10. Vacuum Oven
11. (3) Rotatory Evaporators
12. TDX , Therapeutic Drug Monitoring
13. Water Bath, Refrigerated
14. Dispensers
15. Pipettes.
16. Distillation Apparatus
17. Vacuum Stations
18. Polarometer
19. Particle Counter
20. Pyrogen Tester
21. Laminer Air Flow ( Clean Bench)
22. Zone Reader
23. Autoclaves
.24. Sterilizes
25. Stability Cabinets
26. Flame Photometry
27. Computer ( Using CD- Roms and WHO-QCL Programme) Boiling Point
28. Apparatus.

Control and calibration of equipment Metrology

Is set instrumentation and analysis in the Directorate by the following authorities:
1. 1The supplier or agent of the hardware.
2. National Laboratory of Standards and calibration.
3. Unit of measurement in quality control of the Directorate of Maintenance in the Ministry of Health.
4. Testing and Research Center industry.
5. Medicines Control Laboratory
6. Adjustments of oxidative stress and return.
7. Adjustments weighted
8. Analysis of complexes.
9. Methods of extraction solution.
10. Adjustments for all forms of pharmaceutical

Are control persons by:
1. Quality control unit in the laboratory.
2. Views ISO. As is checking on pharmaceutical laboratories laboratories in this area.

Analyzes plans - Tests - evidence and reagents

Also recorded plans and methods of preparation of reagents and placed on each container: name of the article - caliber - correction factor - the name of the record - Terms of conservation - the preparation and completion date - and any other comments generally follow the approved plans, analysis of the Directorate have been validated note that the plans are constitutional plans has been validated, and all methods of analysis that the Directorate be documented and maintained in ways that analysis in the workplace appropriate or relevant, also referred to a number analysis plan in the book also states analyst any difficulty or Note in this regard. Also available at the Directorate evidence of standard constitutional World Health Organization and the European Pharmacopoeia and the U.S..

Certified standard materials

Standard values are measures of true quality, which is common use in measuring the quality control of products, the basis is very important in the acceptance of products globally and scientifically and technically. These include:
Chemical Reference Materials
Reference Spectra
Reference Data
Reference Products
Electronic Reference Libraries

Bookmark and constitutions Certified Pharmaceutical

The reference in the plans of analysis in the Directorate are as follows:
1. Registration dossier proposed by the laboratory.
2. Constitutions of the global medicines following: - the U.S. Pharmacopoeia. - British Pharmacopoeia. - European Pharmacopoeia. - Pharmacopoeia of the Organization of the World Health Organization - the rest of the constitutions (France - Olmani - Japan - Chini ....).

Constitutions are available in the Directorate of Drug Control Laboratories and Pharmaceutical Research
1. The International Pharmacopoeia ,Third Edition World Health Organization 1994 & addendums. .
2. European Pharmacopoeia On CD -Rom 2005
3. U.S Pharmacopoeia 1995,1996,1997,1998,1999,2003
4. British Pharmacopoeia2002
5. French Pharmacopoeia
6. Japanese Pharmacopoeia

Studies Poster

Partnership Studies is a form of internal study to the informant as provide all laboratory analytical method to analyze specific sections of identical materials are similar and homogeneous. Then it can evaluate the performance of the Plan of descriptive analysis. Can be used for Partnership Studies to develop an analysis plan standard. Governments and trade organizations can request the standard plans follow a standard analysis of the products. A working group of experts in a specific area of analysis to prepare a list of laboratories that will participate to the study. Is assigned to a coordinated team work is then organize the examination of participation with the following phases:
1. Is sending out a text analysis of the proposed plan to all common laboratory study.
2. Be re-sent notes to the plan of analysis to the coordinator of the study
3. Be sent the revised text of the plan of analysis with the samples to all participants.
4. Samples will be analyzed by the participants.
5. Be re-sent the results to the coordinator for statistical evaluation.
6. Report will be sent out to all participants.
7. Be prepared and discussed the way in the final by the Coordinator in consultation with the participants in the study.

Bookmark and constitutions Certified Pharmaceutical

Professional testing programs are designed to test the efficiency of workers in the laboratory analysis can contribute to the selection of good laboratories and the withdrawal of recognition from the laboratories are not eligible. Forms are sent to laboratories in accordance with a specific program and ask them to or more complex analysis of the sample sent to follow the routine applied by the laboratory for each analysis. And send the results to the coordinator of the study and statistical evaluations are carried out and given the quality of marks on each vessel were analyzed. It is assumed in this system and that can be applied broadly to areas of different concentrations. In some cases, laboratories may be required to determine the concentration of vehicles by 5% or 10% or 15%, and in those cases, the standard deviation is different in each concentration

Participation of the Directorate of Drug Control Laboratories in the international professional testing program

Directorate moved to a new stage in quality control through participation in professional 31/5/2001 tests Proficiency Testing organized by the Department of pharmaceutical quality control laboratories in the official OLMCS FIP World Federation of Pharmacists has contributed in support of the Pharmaceutical Control Laboratories in the development of performance and work of the following programs:
1. Project safety and effectiveness of drug carried out in cooperation with the World Health Organization SYR / DSE / 000.
2. Project cycle and control pharmaceutical industry implemented in cooperation with the World Health Organization SYR / HRH / 005
3. Project control system of drug quality, which was implemented with the UNDP, WHO and UNIDO.
4. Rational use of medicine project carried out in cooperation with the World Health Organization.
5. Development Project Directorate carried out in cooperation with the German Foundation for Technical Cooperation GTZ.

International organizations that cooperate with the Ministry of Health, which contribute to the quality control of medicines
1. World Health Organization.
2. United Nations Development Program. .
3. Union of Arab Pharmacists
4. (Arab Union of Producers of medicines and medical supplies (ACDIMA.
5. The Food and Drug Administration.
6. PIC ( Pharmaceutical Inspection Conventio)
7. IFPMA International Federation of Pharmaceutical Manufacturers Associations
8. FTP
9. OLMCS
10. ISO ( International Standardization Organization )
11. ICH ( International Conference on Harmonization )
12. ( Drug Proficiency Testing Programme )
13. ( European Pharmacopoeia Commission )
14. COHRED
15. NLN ( Nordic Council on Medicine ).
16. ( UNICFF s Fund United Nations Children)
17. ( Center for International Drug Monitoring)
18. INRUD ( Intern ional Network for Rational Use of Drugs)

Global network of rational use of medicines
1. The Syrian pharmacential Journal,Published by the Association of Syrian Pharmacists
2. Pharmacopoeias Addenduns And Publications
3. Nordic Council on Medicines .
4. The Norwegian Medicines Control Agency
5. Action Programme on Essential Drugs World Health Organization ..
6. The International Pharmacy ,Official Journal of FIP and the FIP Publications . .
7. Health Horizons,Published by the International Federation of Pharmaceutical Manufacturers Associations ( IFPMA) and the ) IFPMA) Publications
8. CVI FORUM published three times a year by the children's vaccine Initiative )CVI) ( UNICEF , UNDP , The Roche Feller Fumdutions, The World Bank WHO

Selected medical Eastern Mediterranean Region of the Regional Office for the Eastern Mediterranean Region of the World Health Organization

Eastern Mediterranean Region Drug Digest World Health Organization Regional office for the Esterm Mediterranean
1. OAC International Publication published by Association of Official Analytical Chemists,(USA) .
2. The Analyst An international analytical Slience Journal Published by The Royal Society of Chemistry (UK)
3. The Royal Society of Chemistry (UK
4. Chemical Society Reviews (UK) LPS , Medical , News From Britain.
5. In touch , , Kings College London Association pharmacy
6. The Polish Journal of Medicine and pharmacy .
7. Modern Medicine of Middle East .
8. International Pharmacopoeias available at National Drug Quality Assurance and Research Laboratories

Objectives
1. Complete the lion's Center for Health Research. .
2. Increase the technical staff and create incentives to ensure stability and enhance the experience of personnel and modern equipment investment. .
3. Maintain the current quality systems.
4. Completion of the proposed plan to secure materials, chemical and standard spare parts and equipment.
5. The implementation of the largest number of qualitative analysis.
6. The application of laboratory information management program. The LIMS.
7. Subscription patrols and specialized publications and software needed by the Directorate
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