Brief Introduction of Aburaihan Company Organization Policy Organization Chart Qualified Human Resource Production Department Engineering Department

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2 Contents Brief Introduction of Aburaihan Company Organization Policy Organization Chart Qualified Human Resource Production Department Engineering Department Sanitation and Environment Protection Documentation Quality Assurance Department Quality Control Department R & D Department Marketing Department Sales & Export 2

3 GENERAL INFORMATION ON THE MANUFACTURER * Contact information on the manufacturer Aburaihan Pharmaceutical Co. No.1 Hojrebne Oday Avenue, Tehran pars Crossroads, Tehran, I.R.IRAN P.O. Box Tehran, Iran 24 hour contact Telephone No: & Fax No.: address: info@aburaihan.com URL Address: 3

4 Brief Introduction of Aburaihan Co. Aburaihan Pharmaceutical Company is one of the major manufacturers of human and veterinary products in I.R.Iran. Owing to its more than 48 years experience, it plays a great role in the improvement of pharmaceutical industry in I.R.Iran. Aburaihan Pharmaceutical Company was established in 1965 under the ownership of the German Schering Company named "Berlimed of I.R.Iran". In 1981, the Company renamed as " Aburaihan Pharmaceutical Company (Private joint-stock), and finally turned into public joint-stock Company in Aburaihan has the manufacturing license of medicinal products from the ministry of Health in I.R.Iran. Also, some products are being manufactured under the license of some other European Pharmaceutical Companies. The pharmaceutical products of Aburaihan are categorized in two main categories: Human products Veterinary products Aburaihan Pharmaceutical Company in order to produce is Human and Veterinary products, along with supplying raw materials from reputable manufacturers and the exact consideration of cgmp laws and WHO standards for manufacturing and controlling medicine, as well as based on USP, BP, and EP international standards produce the best medicine products with desirable clinical effectiveness. The management of Aburaihan Pharmaceutical Co. announces itself commitment to integration management systems (IMS) in its policy and also emphasize on customer satisfaction, the company order to the managers of units to transfer this important matter to their personnel. Integrated Management System (IMS) at Aburaihan Pharmaceutical Company is based on International Standards ISO 9001:2000 (Quality Management), ISO 14001:2004 (Environment Management) and OHSAS (Occupational Health and Safety 4

5 Management System) which is established with related certificate from RWTÜV of Germany. ISO 9001:2008 Certificate from RWTÜV CERT Certificate No.: ISO 14001:2004 Certificate from RWTÜV CERT Certificate No.: OHSAS 18001:2007 Certificate from RWTÜV CERT Certificate No.: Integrated Management System (IMS) Certificate from RWTÜV system GMBH Certificates No.: Quality Risk Management (QRM) This company has the Quality Risk Management system which is a process for the assessment, control, communication, and review of risks to the quality of the drug product across the product lifecycle. Risk managements activities are performed by some experts from Production, Technical & Engineering, QC and QA department. PREMISES AND EQUIPMENT Factory: 9850 m 2 Production areas: 5927 m 2 Warehouses: 1651 m 2 Utilities and servicing areas: 4235 m 2 Aburaihan Pharmaceutical Company is subgroup of Daroupakhsh Holding Co. and Daroupakhsh Holding Co. is working under guard of TPICO (Tamin Pharmaceutical Investment Company). 5

6 Organization Policy Aburaihan Pharmaceutical Company in order to achieve its goals and enhance quality and customer orientation, environment maintenance and also providing Health and Safety for the society pay attention to the following cases to follow the all cgmp regulations and also incorporating Integrated Management System (IMS) based on international standards including ISO , ISO OHSAS General and constant effort to access the defined goals for products, activities and organizational services leading up to attract domestic and foreign customer's satisfaction and continued improvement. 2. Ensure the implementation of all regulations of cgmp for all production process. 3. Achievement of Quality goals, development of variety and to increase value of products with maintenance of product qualification. 4. To improve executive methods and use of suitable production equipments in order to maintain and enhance products qualification and increase the benefits. 5. Entering to foreign markets to show products. 6. Creating suitable background for performing team work, to raise sharing of motivation and technical knowledge for personnel to access the company's goals. 7. Carrying out all activities based on state, country's laws and regulations, and written laws in ABURAIHAN Pharmaceutical Company. 8. Implementation of Environmental Management Systems in order to prevent the pollution with respect to National and International Standards. 9. Environmental protection in respect of society & considering to the sustainable development 10. Optimal Consumption Management of energy & resource as environmentally friendly industry. 11. Performing Occupational health and safety management systems with respect to Occupational health and safety regulations to reduce risks and hazards. It's necessary that all company's managers inform their subdivision colleagues and personnel, contractors and other interested groups about the written company's policy. They determine require, targets to defined framework of policy and practical methods in order to their objectives. Management's representative Dr. Abdolreza Soleimanifar Managing Director Dr. Akbar Mansouri 6

7 Organization Chart 7

8 Qualified Human Resource Aburaihan Pharmaceutical Company with a knowing and choosing perspective has employed experience, responsible and obligate personnel for its long term goals. This company has started its activities with 90 personnel in At present, the company has 414 employees that they are working to improve company's goals and activities. Company's scientific staff are consist of 115 experts, 2 Physicians, 3 Veterinaries and 12 pharmacist that they are doing their activities based on expertise, obliged and foresight. Training The employee training curriculum is based on the job functions and responsibilities. Employees will be trained by the quality assurance and training departments, head of the departments, and experts who have drafted the procedures and guidelines. Professional development, GMP and ISO training sessions are conducted by the consultants and reputable training organizations. The employee training curriculum will be controlled and monitored by the Human Resource Management and training departments. Classroom training sessions will be conducted when there is a new procedure or the documents have been revised. The new procedure or revisions will be screened by the quality assurance department for version controls and compliance to the internal standards and other external ISO and GMP standards. 8

9 Production Department Aburaihan Pharmaceutical Company's products are divided to two types of Human and Veterinary products. Human's medicine is consist of solid products (types of uncoated tablets, film coated tablets and capsules); Injection (types of water base and oil base ampoules and vials, suspensions and some lyophilized products which will be added as soon as possible), Semi-Solid products (types of Suppositories, Ointments, Cream and Gel). Veterinary products department started in 1991 and now this department produces 29 numbers of Veterinary products that will be added 4 new medicines to other products in There are 3 parts in this department such as Ointment, Cream and Sterile Injection products. The plant is designed to produce oral solid dosage forms as well as Ointments, Creams, Suppositories and Sterile Injectable products. The general production stages of each product group are: Receipt of raw materials and sampling Interim storage of raw materials Weighing Manufacturing Packaging Storage of finished product Distribute 9

10 When the batches are finished, they will be transferred to the warehouse and will be stored until there is an order for these products. The status of all products in the warehouse is indicated by the computer generated labels of on-hold, undertesting, rejected and released products. When the batches are finished, they will be transferred to the warehouse and will be stored until there is an order for these products. The status of all products in the warehouse is indicated by the computer generated labels of on-hold, under-testing, rejected and released products. Sterile products are manufactured and packaged in separate and enclosed areas and under supervision of qualified persons trained in microbiology. The classification of production rooms are based on grade A, B, C, and D as follows: Formulation of products takes place in an environmental where a minimum of grade C condition is maintained. Parenteral products are filled in an aseptic area with at least a grade B environment. Non-parenteral are filled in a grade C environment before terminal sterilization. At Aburaihan Pharmaceutical Company Human's injectable medicine department is consist of two section, Oily Sterile production and Aqueous Sterile production. 10

11 Production Output Aburaihan Pharmaceutical Company's production department will determine its rate of production based on society's demand and its undertakings in relation to public health. The following is Aburaihan's production capability in a year: Product Category Standard Capacity; No. Year (million) Ampoule 36 Tablet (All Types) 1400 Capsule 100 Cream / Ointment / Gel 15 Suppository 180 Veterinary Product 5 Grand Total

12 Engineering Department The engineering department is responsible for maintenance and servicing of all machines and instruments used in the production lines. Sanitation and Environment production The hygiene program at Aburaihan encompasses the clothing requirements, all personnel and visitors who have access to the manufacturing, laboratories, and warehouse areas. Personnel who work in the sterile areas undergo special gowning and sanitation trainings. The hazardous and toxic materials such as Hormones and Steroids materials are stored in a special area in the raw material warehouse. Other sensitive materials are in he warehouse under room temperature or refrigerated depending on the storage condition of materials received in the warehouse. The material safety data sheets are available for all products. 12

13 Documentation Production of all pharmaceuticals is done as per the Master Production Documents, Data sheets for in-process testing and checks, and SOP s. Master production records includes the specification for raw material, packaging material, packaged dosage form, master formula, sampling procedure and critical processing related SOPs. All these documents are cross referenced and linked in order to have better control over the production process and activates. All GMP documents are reviewed and maintained as per the GMP requirements. The production batch records have cover sheets in which describes what kind of documents should be in the batch records. Electronic copies of all documents are stored in the computer data base. Equipment specifications are kept with the machines and controlled by the production, engineering, and quality assurance departments. Specifications for disposables and cleaning materials are kept in the production and quality control areas. The original copies of all standard operating procedures are kept in the quality assurance department and controlled copies are sent to the production, warehouse, and laboratory areas. Quality Assurance Department The Quality Assurance department is controlling all aspects of manufacturing through the quality systems such as Product Certifications, complaint and recalls management, Self- inspection and Internal Audits, and change control. For all these systems qualified individuals are organizing the quality meetings to assess the product releases/rejects, complaints and recalls, and changes in the production lines and procedures. Quality Control Department The Quality Control department at Aburaihan is consists of Analytical, Microbiological, precision instrumentation, and In-Process testing unit. All chemical, microbiological, and physical testing of raw materials, In-Process material, and finished products are done as per the in-house methods and/or other standards, such as 13

14 USP, other pharmacopeias depending on the products. The analytical lab is equipped with very sophisticated instrument such as HPLC, GC, FTIR, KF, and TOC. The In-Process testing unit is responsible for taking sample from raw material, semifinished products and fully finished products for chemical and physical testing as directed in the master production records for every product. Sterility testing, particulate matter, and microbial testing are done in the microbiology laboratory. The product test methods are qualified by the chemists before performing any analysis. Research and Develop Department The Research and Development (R&D) team at Aburaihan develops new drug formulations to improve customer s demand and their point of view in order to promote the high quality products, add to existing formulations and delineate new processes using new product adding strategy. From pre-formulation studies to point batches and commercial scale ups with process validation, we can also handle the entire gamut of actives leading up to finished dossier and DMF compilation. Aburaihan Pharmaceutical Company s R&D department for gaining of company s long term goals doing their activities with perfect expertise and scientific staff that they are consist of pharmacists and chemists, use of software and 14

15 hardware facilities resources and scientific references, documented and confirmed types of systems and research modern equipments. Marketing Department The company's marketing philosophy is based on customer satisfaction belief, and through a continuing focus on strategic planning, launching technologically advanced products & innovative marketing approach, Aburaihan is successfully extracting a remarkable growth from year to year. Aburaihan Pharmaceutical Company believes that customer's satisfaction and trust are its original investment and also believes that this matter can only be accomplished through honesty, obliged and taking responsibility. In this regard, company's marketing unit try to reach and promote this goals. There is service customer management in marketing development which proceeds with company's goals through marketing planning and organization, data collection, data analysis, marketing opportunities analysis. One of the activities of marketing unit is holding instruction classes and several communicative-scientific seminars for inside personnel and visitors, take part in exhibition and its scientific richness for customer survey and service, customer retention and customer training. Sales & Export Department Aburaihan Pharmaceutical Company is considered among the top rank pharmaceutical manufacturing units of I.R.Iran. It holds first rank in hormone drugs in I.R.Iran. It domestic sales increase at least 20% annually. Aburaihan Pharmaceutical Company has emerged as an important player in the I.R.Iran health sector by providing latest medicines of international standards for major diseases, priced with due consideration to the end consumer. Aburaihan Pharmaceutical Company has a network of 36 distributing center via 2 main distributing Co., named Daroupakhsh Co. & Hejrat Co., working nationwide and ensuring the availability of Aburaihan Pharmaceutical Company products for the ailing humanity and having professional field force of more than 40 people to continuously update and persuade the prescribes of I.R.Iran. Aburaihan Pharmaceutical Company believes that the customer is the King. 15

16 Apart from conventional exports our doors are open for. The Aburaihan Pharmaceutical Company s products are competitive and in supply at international markets.because the company s raw material of products are provided from the best and most reputable resources in the world and production process controls and analyses stage by stage. At present, some of company s products are presented and registered is some countries such as Uzbekistan, Tajikistan, Ukraine, Afghanistan, Uganda, Iraq and etc. Aburaihan Pharmaceutical Company s constant effort is based on qualification, honesty, service customer in order to reach more to international markets is to be continued. Customized packaging and portfolio management of products are available in exporting countries according to demographic requirements.