View
227
Download
0
Category
Preview:
Citation preview
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
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 16765-1568
Tehran, Iran
24 hour contact Telephone No: 77 70 71 73-6 & 77 88 23 57
Fax No.: 77702066
E-mail address: info@aburaihan.com
URL Address: www.aburaihan.com
3
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 1981.
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 18001 (Occupational Health and Safety
4
Management System) which is established with related certificate from RWTÜV of
Germany.
► ISO 9001:2008 Certificate from RWTÜV CERT
Certificate No.: 44100 085785
► ISO 14001:2004 Certificate from RWTÜV CERT
Certificate No.: 44104 085785
► OHSAS 18001:2007 Certificate from RWTÜV CERT
Certificate No.: 04116 050321
► Integrated Management System (IMS) Certificate from RWTÜV system GMBH
Certificates No.: 44100 085785
44104 085785
04116 050321
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 m2
Production areas: 5927 m2
Warehouses: 1651 m2
Utilities and servicing areas: 4235 m2
Aburaihan Pharmaceutical Company is
subgroup of Daroupakhsh Holding Co. and
Daroupakhsh Holding Co. is working under
guard of TPICO (Tamin Pharmaceutical
Investment Company).
5
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 9001-2008, ISO 14001-2004 OHSAS 18001-2007.
1. 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
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 1970. 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
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
2012. 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
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.
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
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 1.736
11
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
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
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, semi-
finished 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
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
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.
Recommended