Untitled

Untitled
webcache.googleusercontent.com/search
Page 1
Page 2
ISO 9001
2008
DAROU PAKHSH
PHARMACEUTICAL MFG. CO.
SITE MASTER FILE
DPSMF422
:
CODE
Issued Date: 09/05/2015
Rev. No:3
Validation Date: 09/05/2016
ISO : 4-2
GXP : SMF
Page 1 of 13
This Site Master File was prepared on the basis of the PIC/S document Explanatory notes for industry on
the preparation of a Site Master File PE 008-4.
Contents:
Chapter 1: General information
1.1
Contact information on the manufacturer
1.2
Authorized Pharmaceutical manufacturing activities of the site
1.3
Any other manufacturing activities carried out on the site
1/76
Chapter 2: Quality management system

2-1
the Quality management system of DAROU PAKHSH PHARMACEUTICAL COMPANY
2-2
Release procedure of nished products
2-3
Management of Supplier s &contractors
2-4
QRM(Quality risk management)
2-5
Product quality reviews
Chapter 3: Personnel
Organization of technical division
Chapter4: Premises and equipments
4-1
premises
4-1-1 Brief description of heating, ventilation and air conditioning (HVAC) systems
4-1-2 Brief description of water systems
4-1-3 Brief description of other relevant utilities, such as steam, compressed air, nitrogen, etc.
4-2
Equipments
4-2-1 Listing of major production and control laboratory equipment with critical pieces of equipment
identied should be provided in Appendix 8
4-2-2 Cleaning and sanitation
4-2-3 GMP critical computerized systems
Chapter 5: Documentation
Chapter6: Production
6-1
type of products(reference to appx. 2)
6-2
Process validation
2/76
6-3
Material management and warehousing
Chapter 7: Quality control(QC)
Chapter 8: Distribution ,Complaints, product defects and recalls
Chapter 9: Self inspections
Page 3
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 2 of 13
General appendies
Appendix 1: Copy of valid manufacturing authorization
Appendix 2: List of dosage forms manufactured including the INN-names or common name (as available)
of active pharmaceutical ingredients(API) used
Appendix 3: Copy of valid GMP Certicate
Appendix 4: List of contract manufacturers and laboratories: NA
Appendix 5: Organisational charts
Appendix 6: Lay outs of production areas including material and personnel ows, general ow charts of
manufacturing processes of each product type (dosage form)
3/76
Appendix 7: Schematic drawings of water systems

Appendix 8: List of major production and laboratory equipment
Page 4
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 3 of 13
Chapter 1: General information
DAROU PAKHSH PHARMA. MFG. CO is a subsidiary of Tamin pharmaceutical investment company
(TPICO). which is a wholly owned subsidiary o f Social Security investment Company. This company is a
registered public joint stock company according to the I.R. Iran laws.
1-1
Contact information
Name: Dr.Amjadi Kambiz(senior manager)Dr. Eimagh naeini Babak&Dr. Dolat abadi
Fateme&Dr.zamani farahani Afsane&Dr.Ahmadi Zahra.
Address: 18
th
Km of karaj freeway , Darou Pakhsh Manufacturing pharmaceutical company ,Tehran ,Iran
P.o.Box:11365-4388
Phone:(+98-21)44986815-16
4/76
Fax: (+98-21)44987314
Email: info@dppharma.com
1-2
Authorized Pharmaceutical manufacturing activities of the site
DAROU PAKHSH PHARMA. MFG. CO. is authorized by MOH of I.R. Iran (n T42-74), date August 15,
1972 and ministry of Industry (n 42- 06/60668), date Nov. 30, 1959 to manufacture, import, trade
wholesale and export medications (Appendix 1)
DAROU PAKHSH PHARMA. MFG.CO. manufactures more than 176 pharmaceutical nished products
for human and veterinary in dierent dosage forms: tablets, capsules, oral powders (sachets), oral liquid,
small volume parentherals (SVPs)& large volume parenterals (LVPs), Freeze dried injectables, eye-drops,
creams, ointments and suppositories, lotion, vial and dental cartridges.
For human products, manufacturing licenses are obtained from Iranian Ministry of Health (MOH). In
addition, for veterinary products, the appropriate Licenses are obtained from the veterinary organization of
Ministry of Agricultural. (Appendix 1)
The company is located in suburb of Tehran ; research and development activities , manufacturing , quality
control , marketing and dispatch activities are all carried out at this site. Recently dedicated production
areas e.g. Insulin, Mycophenolate and contrast media are added.
1-3
Any other manufacturing activities carried out on the site
The company imports nutritional supplement products and may produce cosmetics or cosmeceutical
products in future.
Chapter 2: Quality management system
2-1
the Quality management system of DAROU PAKHSH PHARMACEUTICAL COMPANY
DAROU PAKHSH PHARMA. MFG. CO. considers quality in the wide sense of the word as being one of
the key-elements for its success.
DAROU PAKHSH PHARMA. MFG. CO quality system design and implemented with the aim of
producing high quality, healthy and eective drugs in accordance with the principles of GMP,.
, the.Product quality improvement (in aspect of the customer) and the standardization of products and
processes (in the way processes) are determined.as sterategic goals of company.
In this regard, the company in the year 2002 towards the establishment of the ISO 9000 system action and
5/76
in2010 compared to the revision 2008.

Improving quality system, as the unlimited process, has done under the leadership of the Managing
Director, restrict.
Page 5
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 4 of 13
The site operates in conformance with GMP /PICs.
A fully documented quality system is established and maintained which ensures that products, produced,
released and sold meet the specied requirements of the relevant specications .
Senior Management Reviews are held and use Internal Audit results, deviations,CAPAs, external audits to
determine the eectiveness of the quality system.
The Quality system include quality assurance unit,quality control unit and responsible pharmasists are
directly responsible for all aspects of the quality system including, but not limited to:
approval or rejection of all raw materials, components, and product batches,
ensuring the CAPA system is functional,
ensuring that maintenance and calibration systems for critical equipment are eective,
oversight of cleaning and sanitization systems,
cGMP training,
6/76
ensuring that quality related customer complaints are investigated and resolved,
organizing and monitoring recalls, and performing product quality reviews products throughout
The specications for raw materials and nished products as well as for manufacturing and analysis
processes are set out in written procedures, which are periodically controlled.
Written reports are kept on manufacturing conditions and on the controls undertaken during manufacturing
and in the laboratories. This permits monitoring of the companys manufacturing and guarantees their
quality.
The company has certicate of ISO14001&9001 .(Appendix 1)
2-2
Release procedure of nished products
The batch may not be dispatched unless it has been released and is accompanied by a duly signed
certicate of analysis
Quality Unit personnel authorized to review batch documentation and release batches are by responsible
pharmacist of the Quality Control department for the intermediate and nished products.
The batch certication and release procedure is covered by DPWI6377009 Batch Release.
In summary, the person in charge of release reviews all pages of the completed production batch record
and the test sheets from the QC lab to ensure that all parameters were within specication, all spaces for
entering information are completed, signatures and production checks were completed, raw material
usage data is correct and complete, labels are accounted for and excess labels are destroyed, and
calculations are veried If all information is in order, the batch record is stamped RELEASED, BY,
and DATE. Then the batch is released . None of the current control strategies Process Analytical
Technology (PAT). employ
2-3
Management of Supplier s &contractors
The evaluation of suppliers takes into account in various criteria:
The history of the companys relations with the supplier
The quality of products supplied hitherto
cGMP and ISO 9001 certication is a selection criterion (for similar oers, preference is given to a
supplier with such certication)
Results of external audits undertaken by Technical director in collaboration with Industrial Logistics.
Emphasis is placed on the audit of the major suppliers whose products have a signicant impact on the
7/76
quality of DAROU PAKHSH PHARMA. MFG. CO. nished products.
Page 6
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 5 of 13
2-4
QRM
The production unit is responsible for ensuring production deviations are reported and considered; critical
deviations are investigated with conclusions and corrective actions documented,
The production unit also is responsible for ensuring the production facilities are clean in
accordance with site production and quality procedures, ensuring that calibrations are performed and
documented,
ensuring that facility and equipment are maintained and these activities are documented ,reviewing and
approving validation protocols and reports, reviewing and approving changes to products, processes, and
equipment, and ensuring that new and modied equipment are qualied as appropriate.
2-5
Product quality review
Annual Product Reviews are completed for APIs and semi-nished medicinal products
Site Manager, Production Manager, Process Manager, Quality Control, and Quality Assurance reviewed
8/76
and discussed the results of all APR. The studies contain a product summary (number of batches
produced, specications), description of deviations (in-process deviations, complaints, OOSs, etc.), a
description of change control documents, specications and revisions, review starting and packaging
materials, process validation review, equipment and utility review, test data analysis and trends, stability
review, recalls, conclusions, and recommendations. Site meetings are held where corrective action plans
are generated where necessary.
Chapter 3: Personnel
The organization chart provided at appendixe5, outlines the structure of DAROU PAKHSH PHARMA.
MFG. CO. top chart.
3-2 The technical stas are deployed as follows:
Production:
367
Quality control:
87
Maintenance:
80
Warehouses:
76
Regulatory Aair
8
QA:
11
Other
204
TOTAL
833
Training strategies and policies are set according to organizations strategy and the human resource
development requirements; thereby the training total program is set out. The job training needs and the
main content of courses are determined through interview with subject professionals and modied
periodically by job professionals in company. The employee training needs for each personnel and the
training priorities are determined by questionnaire and interview with manager and direct responsible of
9/76
employees, annually.
All the personnel whose jobs could aect the quality of the product (Production, Maintenance, Storage,
Quality Control) receive GMP training that include issues such as pharmaceutical products quality,
personnel, sanitation and hygiene, premises and equipments, materials, documentation. Newly recruited
production personnel (either permanent or temporary employees) receive induction training that covers
good practices in production and packaging the dierent pharmaceutical dosage forms as well as health
and safety. The quality control stas receive previously mentioned training as well as GLP.
Page 7
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 6 of 13
Subjects such as GMP, which the legal obligations require their retraining, are retrained timely. The
specialty issues are retrained in updated cases, which are determined at annually need assessment or are
requested by managers.
Health & safety and environment unit under supervision of Human Resource Department is responsible for
checking employees health & safety and hygiene. Base on persons job and work place hazard DAROU
PAKHSH PHARMA. MFG. CO. has especial physical examination interview and Para-clinic tests
(Eudiometry, Spirometry, Optometry and...). There is periodic employee examination base on their job.
DAROU PAKHSH PHARMA. MFG. CO. has special sickness registration system that report yearly.
10/76
For hi-risk jobs there are special protocols for following and all employees have special examination before
and during their work. DAROU PAKHSH PHARMA. MFG. CO. has special registration system for
worker during return the work after disease. Those who work in aseptic and clean areas have clinical
examination twice a year and examination has dierent.
QC clothing in the laboratory is white. Standard clothing in the production buildings is a blue overall, a
cap/hat and working blue shoes or overshoes. Mechanics who undertake dirty work wear dark blue
overalls.
Overall are washed and pressed once a week inside the company; each collaborate has a set of 2-5 overalls,
permitting once change.
Depending on the type of work and its localisation (for example laminar ow, aseptic arias, controlled
arias, etc) each collaborator wears specic clothing (for example sterilised overall, mask, hood, specic
shoes and gloves).
Chapter4: Premises and equipment
4-1
premises
DAROU PAKHSH PHARMA. MFG. CO. is located in the suburb of Tehran with more than ..
buildings on a 191/650 m2 (see location site in appendix6).
Floor plans are provided in the Appendix 6
The premises are situated, designed, constructed, adapted and maintained in a manner to facilitate
manufacturing, control and cleaning operation.
Manufacturing, packaging, quality control and storage operations are undertaken in buildings.
The Main production building from 1959 houses mainly pharmaceutical production and R&D & quality
control laboratories
From 2010 , renovation have been done in main production buildings under latest GMP and environmental
standards for example sterile production unit and liquids production unit and QC laboratories departments
have been done
Also 3 new production units have been constructed :
1) Insulin production line
2) Growth hormone production line
3) Vial production line
In near future , packaging of solids unit , central weighing departments and semisolids unit will be
11/76
renewed.
Training center & Clinic buildings
These buildings are located outside of the production area and used for personnel training and healthcare.
Page 8
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 7 of 13
4-1-1 HVAC SYSTEM:
Each unit has its own separated HVAC and if necessary dedusters. In all units fresh air is available
according to unit requirements and in solid unit full fresh air exists. HVACs have F9,F7 & G4 and in case
of GMP guidelines H13 lters .
Tempreture , pressure and humidity are monitored and control system creats optimal conditions
4-1-2 Water systems
Water that derivated from well after passing sandy lters is chlorinated by DP(Darou pakhsh) to 0.6ppm.
Chlorinated water is used for general consumption in the company. All units are equipped with pure water
generator which turn the chlorinated water to pure water by RO equipments.
The input water for RO passes through carbon lters for dechlorinating & water softner for reducing
hardness and after passing through membrance lters turns into pure water.
If injectable water is needed, it can be produced from pure water and distillation process.
12/76
The water specications for this unit are those set out in the BP monograph
4-1-1 Steam /Compress air/ Oxygen/ Nitrogen:
Compressed air :
Compressed air is generated by 2 oil-free compressors that work frequently. It is stored in storage tanks
through dryers and then transferred to all units via pips for their usage. All the compressors and
requirements are located in main power plant of the company
Steam:
There is 2 kinds of steam system in DP :
1) Industrial steaming in which steam is generated in the boilers and then transferred through pipes to all
units.
2) Clean steaming in which by using industrial steaming and pure water in the unit itself, clean steaming is
producer and used.
-The available oxygen in compressed air after passing through oxygen generator is separated from
Nitrogen with the purity of 99% and stored in feeding tanks and reached to units that need pure oxygen
vice pipes. This generator is located in the main powerplant of the company
-Nitrogen:
The available nitrogen is compressed air is separated from oxygen with purity of 99.5% when passes
through Nitrogen generator and is stord in storage tanks. This Nitrogen transfer to those units in need of it
via pipes. This generator is located in main powerplant of the company.
4-2
Equipment
The materials used for the construction of apparatus machines used in production are appropriate for their
use (for example, various types of stainless steel); exible silicon pipes can be sterilized. Production
phases requiting aggressive treatments (for example alkaline) are undertaken on materials resistance to
such conditions.
4-2-1 Description of production and control equipment
The Lists of major production and control laboratory equipment are in appx. 3
Page 9
ISO 9001
2008
13/76
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 8 of 13
4-2-2 Equipment cleaning
The manufacturing areas are cleaned and if necessary disinfected after each manufacturing run by the
manufacturing personal according to the current operating procedure.
Large pieces of apparatus are designed to facilities cleaning and/or sterilization in place; small or easily
dismantled pieces of equipment are cleaned by hand or in washing machines (glassware) before being
disinfected or sterilized, if necessary.
The cleaning of the HVAC systems is undertaken regularly with a varying frequency variable depending
on the type of installation.
The microbiological laboratory monitors the microbiological quality of the air in the dierent
manufacturing and control premises.
The frequencies of the controls and the limits set for warnings / actions depend on the type of premises.
A microbiological control of the surfaces is also undertaken in the atmosphere controlled areas .
4-2-3 Electronic monitoring systems:
These systems function as logical control by using PLC. (Programmer logical controller)and HMI(Human
machine Interface) that ultimately lead to control.
EMS system for monitoring and controlling of environment conditions can be accessible locally as well as
an Internet and local Intranet.
Systems for checking sta personnel , materials and products can be programmed by Access control on the
network and assure that only authorized personnel can have access to certain units.
14/76
Chapter 5: Documentation DAROU PAKHSH PHARMA. MFG. CO. has established a document
management system. This system organize the dierent types of documents, i.e.
Quality Manual
process proles
instruction&/or procedures of doing the process
the process instruction &/or procedures of controls and monitoring
Recordes and documents of above
5-1
Control of Documents
Quality system documents are controlled both manual and semi electronic.
the format, Coding, content, approval, distribution, revision, and control of documents describes in
procedures and ensures that only the most current versions of quality system documents are used.
Procedures are in place for manufacturing processes, the quality control laboratory, and all general site
quality procedures. Each controlled procedure is assigned a unique document number, and each document
contains the eective date, revision number, expire date(valid until) signature blocks for the issuer and
approvals , QA manager, and a revision history. Responsible pharmacists signature required for all
documents pertaining to production as dened within the document control SOPs.
5-2
Control of Records
Procedures for ling, storage, and disposal of quality system records are dened in the Quality Records
Management Procedure (DPPR424007).
All written operating area and laboratory records are completed during activities
The following are described in the documentation:
Page 10
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
15/76
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 9 of 13
Product specication
Raw material specication
Packaging material specication
Operating procedure describing the dierent manufacturing steps, including packaging
Analytical methods
Procedure for batch release
The documents for follow-up of manufacturing and analysis, which constitute the batch process
record(BPR).
The BPRs are revised and controlled by the heads of manufacturing divisions, thus certifying that the
batch has been manufactured according to the operating procedures, that all the manufacturing process
controls have been performed and that all the documents released by that division and constituting the BPR
have been correctly and completely lled in. They ensure that any incident has been recorded in the BPR
and reported to Quality Control Department
Each manufacturing run is subject to an output calculation (archive in the BPR) allowing identication of
any abnormal losses.
The BPR are then forwarded to Quality Control Department and submitted to a documented control.
The batch records is in paper version and kept for 1 year after expiry date of batch.
5-3
Change Control
A Management of Change procedure (DPPR824005) is in place to ensure that all changes aecting
quality are reviewed and approved prior to implementation.
It is applicable, but not limited to changes in raw materials or packaging and their sources,
material specications, test methods, manufacturing and analytical equipment, production processes,
16/76
and manufacturing or packaging sites. All such changes that potentially impact product
quality require approval of the Quality unit.
Chapter 6: Production
6-1
Type of products
The list of the products, which manufactured by DAROU PAKHSH PHARMA. MFG. CO. is provided in
the appendix. 2. in a list of human & veterinary & under investigation
6-1-1 Toxic substances
An immunosuppressive drug , Mycophenolate ,is classied as hazardous
6-1-2 Dedicated line
Recently Insulin and Mycophenolate production lines are added as dedicated lines
6-2
process validation
6-2-1 general policy of process validation
process validation newly started and is in progress.
6-2-2 Batch reprocessing
If necessary, batch reprocessing is done according to the dened procedure under deviation and OOS
managment (the procedure is dened by Technical Director, head of QC & QA and Head of Production).
Page 11
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
17/76
ISO : 4-2
GXP : SMF
Page 10 of 13
6-3
Material Management &warehousing
6-3-1 Handling of starting materials, packaging materials, intermediate, semi nished and nished
products, including sampling, quarantine, release and storage.
After reception of any raw and packaging material is put in a quarantine zone and labelled accordingly.
Each delivered article is identied by its article number, its supplier batch number and its internal
DAROU PAKHSH PHARMA. MFG. CO. code number.
The delivered batch is sampled (under laminar ow for the raw materials If necessary) according to
procedures and the sampling plan. The samples are transmitted to the Quality Control laboratories and
analysed. The batch is released or rejected, the labels (under test) covered by another label specifying its
new status and among others its expiration date.
A certicate of analysis is edited and signed by the head of Quality Control Department
The Planning division manages the raw materials stock and designates the batches, which will be
delivered to the production division. They will be weighed, mainly in the central weighing facility then
delivered to the manufacturing departments.
The key manufacturing parameters are described in the manufacturing protocols in the form of columns to
be completed, the operators records the controls carried out: these can therefore found in the Batch
Processing Record.
The authorized operator undertakes empty line checks and controls during the course of manufacturing
and packaging, these controls are recorded in the Batch Processing Report.
Intermediate, semi-nished products are sampled according to the current procedures and analysed by the
Quality Control Department.
The laboratories control that the products meet the physico-chemical, and microbiological specications,
and if applicable biological control and activity specications, as well as the primary and secondary
packaging specications.
As the intermediate and semi- nished products constitute the key step of the production process, the
Quality Control department puts them in quarantine until release or rejection. This is also the case for all
nished products.
18/76
A certicate of analysis signed by the heads of the Quality Control department and a label (Approved) or
(Rejected) is axed.
Acceptance or rejection is made on the basis of:
Batch analysis result
Review of the Batch Processing Record
Evaluation of possible non-conformities related to the manufactured batch
The storages areas are buildings, which guarantee the security and the quality of the raw materials and
products stored (limited access, re detection and extinguisher system, temperature control).
Samples are taken if necessary in sampling rooms under laminar ow. Raw materials are stored in
containers, which protect them from dust.
The storage area is equipped with air- conditioned rooms for raw materials and products that are sensitive
to temperature variations and there is a cold room for the storage for sensitive raw materials. .
Page 12
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 11 of 13
The materials in quarantine are stored in a reserved and labeled area.
The status of raw materials, packing materials, intermediate, semi nished and nished products is
indicated by a system of labeling which indicates clearly whether a material or a product is in quarantine,
19/76
released or rejected.
Raw materials are used on a First In, First Out (FIFO) basis, as indicated by their expiration date. The
nished products follow in general this principle (except in the case indicated above, when a batch is
reserved for a particular client).
6-3-2 Handing of rejected products and materials
Rejected products are clearly labelled (red labels); they are stored in an area designed for this purpose.
When a sucient quantity of materials to be destroyed has accumulated, they transported to an
incineration center and destructed according to the guidelines of MOH.
Chapter 7: Quality Control
7-1
Physico-chemical laboratory:
Physico-chemical control and analysis of the quality of the starting materials. intermediate and nished
products.
7-2
Biology laboratory
Microbiological control and analysis of the quality of the raw materials, intermediate and nished
products.
Control of the microbiological quality of the Water ,environment (air, surfaces) and utilities.
Biological control and analysis of raw materials, intermediate, and nished products.
7-3
In process QC laboratory
In process control of packaging materials, production procedures, nished products and other dierential
important Parameters such as Temperature, Humidity, Pressure, Air Particle counting and .
7-4
Biotechnology laboratory
Biological assay of insulin , growth hormone , heparin ,enoxoparine and similar drugs.
Chapter 8: Distribution Complaints, PRODUCT DEFECTS & RECALLS
The distribution companies that The DAROU PAKHSH PHARMACEUTICAL MFG. Co. is deal with are:
Darou Pakhsh distribution Company, Momtaz Distribution Company, Exir Company, Poorapakhsh
Company, Darougostar Razi Company, Hejrat Company, Behresan Darou Company, Mahya Darou
Company.
20/76
8-1 Distribution
Batches of products packed are stored; After releasing the batches and when an order arrives, the quantity
required is taken from stock.
The distribution follow- up system allows a batch to be traced from manufacturing to the customer (date of
delivery, quantity, name and address of the customer).
Page 13
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 12 of 13
8-2 Complaints and Recalls
There is a written procedure for dealing with quality complaints.
This procedure describes in particular the actions to be taken in case of compliant and the responsibilities
of the persons that make up the committee for handling complaint, which include among others:
The Technical Director who has responsibility for setting up a centralized documentation of all
information, reports, forms, minutes of meeting, etc. and for assembling the batch record concerning
each complaint, for determining the exact nature of the complaint and for nishing its cause.
The head of Marketing Department, whose task is to provide a list of customers who have received the
incriminated batch and establish an inventory of remaining stocks within the company.
The head of Quality Control who is responsible for labeling and control of storage of the incriminated
21/76
batch, for verifying reference samples, for using or developing control methods in order to complete the
inquiry.
Reports are prepared for the dierent stages in handling the complaint; a nal report closes the matter. The
reports are submitted to the compliant handling committee; the members of this committee receive a copy
of the nal report; this system ensures the control of these documents.
Each compliant le is retained for at least 2 years after expiring date of the product.
The above-mentioned procedure is also used in case of recalls; it describes the process to be followed when
compliant - internal company information or a demand from the authorities justies a recall.
This procedure mentions in particular the sequence of actions to be taken and who is responsible for:
Tracing distribution
Information customers (and how)
Receipt, separate storage and labeling of the returned batch
Inquiring into the cause of the recall
Proposing corrective actions
Coordinating operations related to the recall (establishing the cause of the compliant, contacts with the
authorities, writing of the communications to be issued to the media, report on the progress of return of
the batch).
The decision making scheme describe in this procedure allows to evaluate the risk, and if necessary to
inform the authorities.
The procedure refers to the classication of the quality defects According to MOH of Iran guideline for
setting the mode of recall.
Chapter 9: Self inspection
9-1 Internal audit
The internal audit system is managed by the Responsible pharmasist and /or QA manager and is subject to
a Written Instruction (WI).
The division involved in manufacturing, storage and controls are regularly audited by the Responsible
pharmacist and /or QA manager based on a program.
In addition, internal audits may be required in particular cases, for example in the case of a recall, when
products are repeatedly rejected, or at the introduction of a new production.
The observed weak points are subjected to corrective actions whose implementation and follow up are
the responsibility of the head of the audited division and of the the Responsible pharmasist and /or QA
22/76
manager, respectively.
Page 14
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 13 of 13
Archiving of the internal audit les (records, reports, follow- up on corrective actions, etc ) is done by
the Responsible pharmacist and /or QA manager.
Page 15
Appendix 1
Copy of valid manufacturing
authorisation
Page 16
ISO 9001
2008
DAROU PAKHSH
23/76
SITE MASTER FILE

DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 1 of 2
Page 17
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 2 of 2
Page 18
Appendix 2
List of dosage forms manufactured
24/76
including the INN names or common

name of API used
Page 19
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 1 of 10
Product List
Darou Pakhsh Pharmaceutical Mfg. Co.
Category
No.
Product name
Dosage form
Packaging
Analgesics, Antipyretics
1
A.C.A
Tab.
100
2
25/76
Acetaminophen
Oral Drop, 15ml
1
3
Acetaminophen
Supp. 125mg
5
4 Acetaminophen
Supp. 325mg
5
5
Dipifen
(Acetaminophen/Caeine/Ibuprofen)
Cap.
30
6
Acetaminophen Codeine
Tab. 300/10mg
100
7
Adult Cold
Tab.
100
8
A.S.A
Chew. Tab. 100mg
100
9 A.S.A
Tab. 325mg
100
10
26/76
A.S.A Codeine
Tab. 500/10mg
100
11
Celexib ( Celecoxib )
Cap. 100mg
60
12
Celexib ( Celecoxib )
Cap. 200mg
60
13
Children Cold
Chew. Tab.
100
14 Diclen ( Diclofenac )
Gel 1%
1
15
Diclen ( Diclofenac Sodium )
Amp. 25mg/ml, 3ml
5
16
Diclofenac Sodium
Supp. 50mg
5
17
Diclofenac Sodium
Supp. 100mg
5
18
27/76
Ibuprofen
Tab. 400mg
100
19 Indomethacin
Cap. 25mg
100
20
Indomethacin
Supp. 50mg
5
21
Indomethacin
Supp. 100mg
5
22
Methyl Salicylate
Top. Oint. 30%, 30g
1
23
Piroxicam
Top. Gel 0.5%, 60g
1
24 Tramadol
Amp. 50mg/ml
10
25
Tramadol
Cap. 50mg
30
26
Tramadol ER
28/76
Tab. 100mg
100
Anesthesia adjuncts
27
Alfentanil
Amp. 0.5mg/ml, 2ml
10
28
Alfentanil
Amp. 0.5mg/ml, 5ml
10
29 Atracurium besylate
Amp. 10mg/ml , 2.5ml
5
30
Atracurium besylate
Amp. 10mg/ml , 5ml
5
31
Fentanyl citrate
Amp. 50mcg/ml, 2ml
10
32
Fentanyl citrate
Amp. 50mcg/ml, 10ml
5
33
Lidocaine
Amp. 2%,5ml
5
34
29/76
Persocaine-E ( Lidocaine +
Epinephrine )
Cartridge 1.8ml
50
35
Midazolam
Amp. 5mg/ml, 1ml
10
Page 20
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 2 of 10
36
Midazolam
Amp. 5mg/ml, 3ml
5
37
Dentanest ( Prilocaine + Felypressin ) Cartridge 1.8ml
50
30/76
38
Sufentanil
Amp. 5mcg/ml, 2ml
10
39 Sufentanil
Amp. 5mcg/ml, 5ml
10
Antiacne agents
40
Adapalene
Top. Gel 0.1%, 30g
1
41
Clindamycin
Top. Sol. 1%, 60ml
1
42
Metronidazole
Top. Gel 0.75%, 30g
1
43
Tretinoin
Lotion 0.05%, 15ml
1
44 Tretinoin
Top. Gel 0.025%, 15g
1
45
Tretinoin
Top. Gel 0.05%, 15g
1
31/76
Antiasthmatic agents
46
Montelukast
Chew.Tab. 5mg
30
47
Zarlukast*
Tab. 20mg
30
Anti-Cancer agents
48
Spinal-Z
Cap.
30
Anticholelithic
49 Ursodeoxycholic Acid
Cap. 250mg
50
Anticoagulant agents
50
Enoxaparin
Inj.6000 IU/0.6 ml
5
51
Enoxaparin
Inj.10000 IU/ ml
5
52
Heparin Sodium
Inj. 5000IU/ml, 1ml
10
32/76
53
Heparin Sodium
Inj. 10000IU/ml, 1ml
10
Anticonvulsants
54 Divalproex
E.C. Tab. 500mg
90
55
Gabapentin
Cap. 100mg
100
56
Gabapentin
Cap. 300mg
100
57
Gabapentin
Cap. 400mg
100
58
Oxcarbazepine
Tab. 300mg
100
59 Phenobarbital
Tab. 60mg
100
60
Phenobarbital
Tab. 100mg
100
33/76
61
Topiramate
Tab. 25mg
30
62
Topiramate
Tab. 50mg
30
63
Topiramate
Tab. 100mg
30
64 Topiramate*
Tab. 200mg
30
Antidepressants\Antipsychotics
65
Amitriptyline
Tab. 10mg
100
66
Amitriptyline
Tab. 25mg
100
67
Amitriptyline
Tab. 100mg
100
68
Tripline ( Amitriptyline )
Tab.100mg
34/76
100
69 Citalopram
Tab. 20mg
20
70
Citalopram
Tab. 40mg
20
71
Clozapine
Tab. 25mg
100
72
Clozapine
Tab. 100mg
100
73
Doxipen ( Doxepin )
Cap. 10mg
60,100
74 Doxipen ( Doxepin )
Cap. 25mg
60,100
75
Duloxetine*
Cap. 30mg
30
Page 21
ISO 9001
2008
35/76
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 3 of 10
76
Nortriptyline
Tab. 10mg
100
77
Nortriptyline
Tab. 25mg
100
78
Perphenazine
Amp. 5mg/ml, 1ml
10
79 Perphenazine
Tab. 2mg
100
80
Perphenazine
Tab. 4mg
100
36/76
81
Perphenazine
Tab. 8mg
100
82
Trazodone
Tab. 50mg
100
83
Venlafaxine S.R.
Cap. 75mg
30
84 Venlafaxine S.R.
Cap. 150mg
30
85
Venlafaxine
Tab. 37.5mg
60,100
86
Venlafaxine
Tab. 75mg
60,100
Antidiabetic agents
87
Dipisulin-(70/30) ( Insulin 70/30 )
Vial (70IU NPH+30IU
Regular)/ml, 10ml
1
88
Dipisulin-N ( Insulin NPH Human )
37/76
Vial 100IU/ml, 10ml

1
89 Dipisulin-R ( Insulin Regular Human ) Vial 100IU/ml, 10ml
1
90
Pioglitazone
Tab. 15mg
30
91
Pioglitazone
Tab. 30mg
30,100
92
Repaglinide
Tab. 0.5mg
30
93
Repaglinide
Tab. 1mg
30
94 Repaglinide
Tab. 2mg
30
Anticholinergic\Antispasmodic
95
Atropine Sulfate
Amp. 0.5mg/ml, 1ml
10
96
Atropine Sulfate
Amp. 10mg/ml, 2ml
38/76
10
97
Tizanidine
Tab. 4mg
100
Antiemetic
98
Granisetron
Amp. 1mg/ml, 1ml
5
99 Granisetron
Amp. 1mg/ml, 3ml
5
100 Metoclopramide
Amp. 5mg/ml, 2ml
10
101 Metoclopramide
Oral Drop 4mg/ml, 15ml
1
Antifungals
102 Griseofulvin
Tab. 125mg
100
103 Ketoconazole
Lotion 2%, 20ml
1
104 Ketoconazole
Top. Cream 2%, 30g
1
105 Tolnaftate
Top. Sol. 1%, 10ml
39/76
1
Antihepatitis B
106 Adefovir
Tab. 10 mg
30
Antihistamins
107 Cetirizine
Syr. 5mg/5ml, 60ml
1
108 Cetirizine
Tab. 10 mg
100
109 Chlorpheniramine
Amp. 10 mg/ml, 1ml
10
110 Chlorpheniramine
Tab. 4mg
100
111 Cyproheptadine
Tab. 4mg
100
112 Diphenhydramine
Elixir 12.5mg/5ml, 60ml
1
113 Fexofenadine*
Tab. 120mg
30
114 Hydroxyzine
Syr. 10mg/5ml, 120ml
1
115 Hydroxyzine
40/76
Tab. 10mg
100
Page 22
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 4 of 10
116 Hydroxyzine
Tab. 25mg
100
117 Loratadine
Syr. 5mg/5ml, 60ml
1
118 Loratadine
Tab. 10mg
100
119 Pediatric Grippe
Syr. 60ml
1
Antihyperlipidemia
41/76
120 Atorvastatin
F.C Tab. 10mg
30,100
121 Atorvastatin
F.C Tab. 20mg
30,100
122 Atorvastatin
F.C Tab. 40mg
30,100
123 Ezetimibe
Tab. 10mg
30
124 Lovastatin
Tab. 20mg
20
Anti-inammatory
125 Enoxolone
Oint. 2%, 15g
1
Antibacterial agents
126 Amikacin Sulfate
Amp. 50mg/ml, 2ml
10
127 Amikacin Sulfate
Amp. 250mg/ml, 2ml
10
128 Ciprooxacin
Tab. 250mg
30
129 Ciprooxacin
Tab. 500mg
42/76
20
130 Clindamycin
Amp. 150mg/ml, 2ml
10
131 Co-trimoxazole
Tab. 400/80mg
100
132 Gentamicin
Amp. 10mg/ml, 2ml
100
133 Gentamicin
Amp. 40mg/ml, 1ml
100
134 Gentamicin
Amp. 40mg/ml, 2ml
100
135 Isoniazid
Tab. 100mg
100
136 Isoniazid
Tab. 300mg
100
137 Moxioxacin
Tab. 400mg
10
138 Mupirocin
Oint. 2%, 15g
1
139 Ooxacin
Tab. 200mg
30
43/76
140 Ooxacin
Tab. 300mg
30
Antimigraine
141 Ergotamine-C
Tab. (1+100)mg
100
142 Rizatriptan
Tab. 10mg
15,30
143 Sumatriptan
Tab. 100mg
10
144 Megrif* (Sumatriptan+Naproxen)
Tab. (85+500)mg
9
Antiparasites
145 Pyrvinium Pamoate
Susp. 50mg/5ml, 50ml
1
Antipsoriasis
146 Calcipotriol
Top. Oint. 0.005%, 30g
1
Antitussives
147 Diphenhydramine compound
Syr. 60ml
1
148 Expectorant Codeine
Syr. 60ml
1
44/76
Antiviral agent
149 Aciclovir
Tab. 200mg
30
150 Aciclovir
Tab. 400mg
30
151 Myrtoplex
Top. Oint. 10%, 5g
1
Bronchodilators
152 Aminophylline
Amp. 25mg/ml, 10ml
5
153 Epinephrine
Amp. 1mg/ml, 1ml
10
154 Epinephrine
Amp. 0.1mg/ml, 10ml
5
155 Salbutamol
Syr. 2mg/5ml, 120ml
1
Page 23
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
45/76
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 5 of 10
156 Salbutamol
Tab. 2mg
100
157 Theophylline ER
Tab. 100mg
100
158 Theophylline ER
Tab. 200mg
100
159 Theophylline G
Syr. (50+30)mg/5ml,
120ml
1
Cardiovascular agents
160 Amlodipine
Tab. 5mg
30,100
161 Amlodipine 5/Atorvastatin 20
Tab. (5+20)mg
30
162 Atenolol
Tab. 50mg
100
46/76
163 Atenolol
Tab. 100mg
100
164 Captopril
Tab. 25mg
100
165 Captopril
Tab. 50mg
100
166 Carvedilol
Tab. 6.25mg
30
167 Carvedilol
Tab. 12.5mg
30
168 Dipix (Clopidogrel)
Tab. 75mg
30
169 Diltiazem
Tab. 60mg
100
170 Lozaten ( Losartan Potassium )
Tab. 25mg
100
171 Lozaten ( Losartan Potassium )
Tab. 50mg
100
172
Lozaten-H (
Losartan+Hydrochlorothiazide )
Tab. (50+12.5)mg
47/76
30
173 Methyldopa
Tab. 250mg
100
174 Valsartan
Tab. 40mg
100
175 Valsartan
Tab. 80mg
100
Cognitive enhancer
176 Piracetam
Oral Sol. 33.3%, 120ml
1
177 Piracetam
Tab. 800mg
50
Contrast media agents
178 Barex ( Barium Sulfate )
Sachet 135g
15
179 Gadopentetate dimeglumine
Vial. 469mgI/ml, 20ml
24
180 Iodixanol*
24
181 Iodixanol*
10
182 Iodixanol
48/76

24
183 Iodixanol
10
184 Iodixanol
10
185 Iopamidol
24
186 Iopamidol*
10
187 Iopamidol
24
188 Iopamidol*
10
189 Iopaque ( Iohexol )
Amp. 240mgI/ml, 10ml
5
5
24
192 Iopaque ( Iohexol )*
49/76
10
5
5
Page 24
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 6 of 10
24
196 Iopaque ( Iohexol )*
10
50/76
5
198 Meglumine Compound
Amp. 60%, 20ml
5
199 Meglumine Compound*
Vial. 60%, 20ml
24
200 Meglumine Compound
Amp. 76%, 20ml
5
201 Meglumine Compound*
Vial. 76%, 20ml
24
Dementia symptoms
treatment
202 Donepezil
Tab. 5mg
100
203 Donepezil
Tab. 10mg
100
204 Galantamin
Tab. 8mg
100
205 Memantine
Tab. 5mg
10
206 Memantine
Tab. 10mg
10
207 Rivastigmine
51/76
Cap. 1.5 mg
100
208 Rivastigmine
Cap. 3 mg
100
Diuretics
209 Hydrochlorothiazide
Tab. 50mg
100
Erectile Dysfunction
210 Tadalal
Tab. 10mg
4
211 Tadalal
Tab. 20mg
4
Gastrointestinal agents
212 Esomeprazole*
Cap. 40mg
30
213 Mebeverine
Tab. 135mg
50
214 Mebeverine E.R.*
cap. 200mg
30
215 Omeprazole
Cap. 20mg
14
216 Rabeprazole*
Tab. 20mg
52/76
30
217 Ranitidine
Amp. 25mg/ml, 2ml
10
218 Ranitidine
Tab. 150mg
100
Growth hormone
219 Dipitropin (Somatropin)*
Vial 4 I.U.
1
Hypopigmenting agents
220 Mequinol
Top. Oint. 10%, 30g
1
221 Mequinol-T
Top. Sol. 60ml
1
Immunosuppressant agents
222 Cytocept (Mycophenolate Mofetil)
Tab. 500mg
50
Infertility therapy adjuncts
223
H.C.G. (Human Chorionic
Gonadotrophin)
for Inj. 500IU
5
224
Gonadotrophin)
53/76
for Inj. 1500IU

5
225
Gonadotrophin)
for Inj. 5000IU
5
226 H.M.G. (Menotropin)
for Inj. 75IU LH+75IU
FSH
5
Infusions & Irrigation
Solutions
227 Dextrose 3.33%, NaCl 0.3%
Infu. 500ml
1
Infu. 1Lit.
1
229 Dextrose 5%
Infu. 500ml
1
230 Dextrose 5%
Infu. 1Lit.
1
231 Dextrose 5%, NaCl 0.9%
Infu. 500ml
1
232 Dextrose 5%, NaCl 0.9%
Infu. 1Lit.
1
54/76
233 Dextrose 50%

Infu. 500ml
1
Page 25
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 7 of 10
234 Ringer
Infu. 500ml
1
235 Ringer
Infu. 1Lit.
1
236 Sodium Chloride 0.45%
Infu. 500ml
1
Infu. 1Lit.
1
55/76

Infu. 500ml
1
Infu. 1Lit.
1
Sol. For Irrigation 500ml
1
Sol. For Irrigation 1Lit.
1
242 Sterile water for Injection
Amp. 5ml
100
243 Sterile water for Injection
Amp. 5ml, PE
50
Mucolytics
244 Bromhexine HCl
Elixir 4mg/5ml, 60ml
1
245 Expectorant
Syr. 60ml
1
Narcotics
246 Codeine Phosphate
Tab. 30mg
500
247 Methadone
Amp. 5mg/ml, 1ml
56/76
100
248 Methadone
Syr. 25mg/5ml, 250ml
1
249 Methadone
Tab. 5mg
100
250 Methadone
Tab. 20mg
100
251 Methadone
Tab. 40mg
100
252 Methadone
Dispersible Tab. 20mg
100
253 Methadone
Dispersible Tab. 40mg
100
254 Morphine Sulfate
Amp. 10mg/ml, 1ml
100
255 Opium
Tincture 1%, 250ml
1
Nasal Decongestant
256 Naphazoline
Nasal Drops, 0.05%,
10ml
1
Ophthalmic agents
57/76
257 Betamethasone
Ophthalmic Drops 0.1%,
5ml
1
258 Brimonidine
5ml
1
259 Cromolyn Sodium
Ophthalmic Drops 2%,
5ml
1
260 Dexamethasone
5ml
1
261 Dorzolamide
Ophthalmic Drops 2%,
5ml
1
262 Gentamicin
5ml
1
263 Ketotifen
Ophthalmic Drops
0.025%, 5ml
1
264 Latanoprost
Ophthalmic Sol.
50mcg/ml, 2.5ml
58/76
1
265 Naphazoline
10ml
1
266 Olopatadine
5ml
1
267 Tetracaine
5ml
1
Page 26
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 8 of 10
268 Timolol
59/76
5ml
1
Oral electrolyte
269 O.R.S.
Sachet 20.5 g
20
Skeletal muscle relaxants
270 Methocarbamol
Amp. 100mg/ml, 10ml
5
271 Methocarbamol
Tab. 500mg
100
272 Pancuronium Bromide
Amp. 2mg/ml, 2ml
10
Skin healing agents
273 Phenytoin Sodium
Top. Cream 1%, 30g
1
274 Zinc oxide
Top. Oint. 25%, 30g
1
Steroidal anti-inammatory
agents
275 Betamethasone
Amp. 4mg/ml, 1ml
100
276 Betamethasone
Top. Cream 0.1%, 15g
1
60/76
277 Betamethasone
Top. Lotion 0.1%, 20ml
1
278 Betamethasone
Top. Oint. 0.1%, 15g
1
279 Betamethasone L.A.
Amp. 1ml
10
280 Clobetasol
1
281 Clobetasol
Top. Lotion 0.05%, 25ml
1
282 Clobetasol
Top. Oint. 0.05%, 15g
1
283 Dexamethasone
Amp. 4mg/ml, 2ml
100
284
Dipimedrol*(Methylprednisolone
acetate)
Amp. 40mg/ml , 1ml
10
285
Dipimedrol*(Methylprednisolone
acetate)
vial. 40mg/ml , 1ml
1
61/76
286 Fluocinolone Acetonide

1
287 Fluocinolone Acetonide
Top. Oint. 0.025%, 15g
1
288 Hydrocortisone
Top. Oint. 1%, 15g
1
289 Hydrocortisone sodium phosphate
Amp. 50mg/ml, 2ml
10
290
Hydrocortal (Hydrocortisone sodium
succinate)
for inj. 100mg
5
291 Triamcinolone
Amp. 40mg/ml, 1ml
5
Sweetening agents
292 Aspartam
Tab. 18.5 mg
100
Prostatic hyperplasia therapy
agent
293 Tamsulosin
E.R. Cap. 0.4mg
100
Uterine relaxant
294 Ritodrine
62/76
Tab. 10mg
100
Vitamins, Minerals & Dietary
supplements
295 Borage Oil (RP Scherer)
Softgel 500mg
100
296
Calcium-D Fort (Calcium
carbonate+Vit.D3)
Caplet 500mg+400IU
100
297 Calcium-D
Caplet 500mg+200IU
50
298 Clear Vision Eye Care (RP Scherer)
Softgel
100
299 Cod Liver Oil (RP Scherer)
Softgel
100
300 SeaPearl (Cod liver oil)
Softgel 300IU
100
301 SeaPearl (Cod liver oil)
Softgel 1000IU
30
302 CoQ10
Cap. 30mg
30
303 Quzyme (CoQ10)*
63/76
Softgel. 30mg
30
304 Energy Plus (RP Scherer)
Softgel
100
Page 27
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 9 of 10
305 Evening Primrose Oil (RP Scherer)
Softgel 500mg
100
306 Evening Primrose Oil (RP Scherer)
Softgel 1000mg
100
307
Evening Primrose Oil+Vitamin E nat.
(RP Scherer)
Softgel 500mg+6.71mg
64/76
100
308 Feriron (Ferrous Sulfate)
Oral Drops 25mg/ml,
15ml
1
309 Feriron (Ferrous Sulfate)
Tab. 50mg Fe2+
100
310 Lipex (Fish oil)
Softgel 1000IU
50
311
Quzyme Fort (Fish
Oil+CoQ10+Selenium)*
Softgel
(500+100+75.2)mg
30
312 Glucosamine Sulfate
Tab. 500mg
60
313
Arthriex-C
(Glucosamine+chondroitin)
Soet (500+400)mg
30
314 Glucosamine+chondroitin
Caplet (500+400)mg
100
315 Glucosamine+chondroitin+MSM*
Caplet
(500+400+125)mg
65/76
50
316 L-Carnitine/CoQ10
Cap. (50+10)mg
100
317 Lecithin (RP Scherer)
Softgel 1200mg
100
318 Multivitamin
Syr. 60ml
1
319 Multivitamin for skin (RP Scherer)
Softgel
100
320 Multivitamin M*
Cap.
100
321 Multivitamin P*
Cap.
100
322 Multivitamin plus Mineral
Cap.
100
323 Multivitamin Therapeutic
Cap.
100
324 Omega-3 (RP Scherer)
Softgel 1000mg
100
325 Royal Jelly+Ginseng (RP Scherer)
Softgel
100
66/76
326 Soy Isoavone (RP Scherer)

Softgel 40mg
100
327 Vitamin A+D
Top. Oint. 30g
1
328
Vitamin ACE+Selenium yeast (RP
Scherer)
Softgel
100
329 Vitamin B complex
Amp. 2ml
100
330 Vitamin B complex
Tab.
100
331 Vitamin B1
Tab. 100mg
100
332 Vitamin B1
Tab. 300mg
100
333 Vitamin B1/B6/B12
Amp.
(100+100+1)mg/3ml, 3ml
5
334 Vitamin B12
Amp. 100mcg/ml, 1ml
10
335 Vitamin B12
67/76
Amp. 1000mcg/ml, 1ml

10
336 Vitamin B6
Amp. 50mg/ml, 2ml
10
337 Vitamin B6
Amp. 100mg/ml, 3ml
10
338 Vitamin B6
Tab. 40mg
100
339 Vitamin C
Amp. 100mg/ml, 5ml
10
340 Vitamin C
Chew. Tab. 250mg
100
341 Vitamin D3
Amp. 300000IU/ml, 1ml
10
Page 28
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
68/76
Rev. No:3
ISO : 4-2
GXP : SMF
Page 10 of 10
342 Vitamin E
Chew. Tab. 100IU
100
343 Evital (Vitamin E)
Softgel 200
100
344 Evital (Vitamin E)
Softgel 400
100
345 Vitamin E nat. (RP Scherer)
Softgel 134mg, 200IU
100
346 Vitamin E nat. (RP Scherer)
Softgel 268mg, 400IU
100
347 Wheat Germ Oil (RP Scherer)
Softgel 1000mg
100
348 Zinc Gluconate-C-E (RP Scherer)
Softgel (5+60+12)mg
100
Veterinary Products
349 AD3E
Oral Sol. 1000ml
1
350 Betamethasone
69/76
Amp. 8mg/ml, 10ml

5
351 Betamethasone*
Vial. 8mg/ml, 50ml
1
352 Bromhexine HCl
Sol. 1%, 250ml
1
353 Bromhexine HCl
Sol. 1%, 1000ml
1
354 Cetrimide-C
Sol. 250ml
1
355 Cetrimide-C
Sol. 3.8Lit
1
356 Dexamethasone
Amp. 4mg/ml, 10ml
5
357 Dexamethasone*
Vial. 4mg/ml,50ml
1
Infu. 500ml
1
Infu. 1Lit.
1
360 Dextrose 5%
Infu. 500ml
70/76
1
361 Dextrose 5%
Infu. 1Lit.
1
362 Gentamicin
Amp. 50mg/ml, 10ml
5
363 Gentamicin*
Vial. 50mg/ml, 50ml
1
364 Pregnan (H.C.G.)
Amp. 1500IU
5
365 Levamisole
Vial 7.5%, 50ml
1
366 Neomycin Sulphate
Top. Oint. 1%, 15g
1
367 Promethazine
Amp. 25mg/ml, 10ml
5
368 Promethazine*
Vial. 25mg/ml, 50ml
1
369 Vit. B Complex
Amp. 10ml
5
370 Vit. B Complex*
Vial. 50ml
1
71/76
*Will be in the market soon
Page 29
Appendix 3
Copy of valid GMP Certicate
Page 30
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 1 of 2
Page 31
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
72/76
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Page 2 of 2
Page 32
Appendix 5
Organisational chart
Page 33
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
DPSMF422
:
CODE
Rev. No:3
ISO : 4-2
GXP : SMF
Auditing Manager
Auditing Committee
Strategic Plans Committee
Strategic Planning Manager
73/76
Managing Director
Consultants
Secretarial
Operation VP
Quality Assurance VP
Logistics VP
Finance & Economy VP
Business
Development
Manager
Novel
Technologies
Manager
R&D
Manager
Public Relation
& International
Aairs Manager
Responsible
Pharmacists
Scientic Research
& Marketing
Studies Manager
Sales
Manager
Commercial
Manager
Security
Manager
Legal &
Contracts
74/76
Manager
Board of Directors
Page 34
ISO 9001
2008
DAROU PAKHSH
SITE MASTER FILE
CODE: DPSMF422
Issued Date: 09.05.2015
Rev. No: 3
Validation Date:09.05.2016
ISO : 4-2
GXP : SMF
Managing Director
Biologic & Biotechnology
Products Responsible
Pharmacist
Semisolid & Oral Liquid &
supplements Responsible
Pharmacist
Sterile Products Responsible
Pharmacist
Solid Responsible
Pharmacist
Responsible
Pharmacist Expert
Responsible
Pharmacist Expert
Responsible
75/76
Pharmacist Expert
Responsible
Pharmacist Expert
Secretarial
Secretarial
Secretarial
Secretarial
76/76

Untitled

Загружено:

Сведения о документе

Оригинальное название

Авторское право

Доступные форматы

Поделиться этим документом

Поделиться или встроить документ

Параметры публикации

Этот документ был вам полезен?

Это неприемлемый материал?

Авторское право:

Доступные форматы

Untitled

Загружено:

Авторское право:

Доступные форматы

Untitled

Chapter 2: Quality management system

Appendix 7: Schematic drawings of water systems

in2010 compared to the revision 2008.

quality of DAROU PAKHSH PHARMA. MFG. CO. nished products.

SITE MASTER FILE

including the INN names or common

Vial 100IU/ml, 10ml

Vial. 270mgI/ml, 20ml

for Inj. 1500IU

233 Dextrose 50%

238 Sodium Chloride 0.9%

286 Fluocinolone Acetonide

326 Soy Isoavone (RP Scherer)

Amp. 1000mcg/ml, 1ml

Amp. 8mg/ml, 10ml

*Will be in the market soon

Вам также может понравиться