general information...dr. ahmed ali dr. hamdan al rawi 1. general information 1.1 brief description:...
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MIDDLE EAST LBORATORIES CO. LTD. SITE MASTER FILE
BAGHDAD -IRAQ
1 | P a g e EFFECTIVE DATE 1/3/2013 REVISION NO. / 1
PREPARED BY REVIEWED BY APPROVED BY
CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
1. GENERAL INFORMATION
1.1 Brief Description:
Middle East Laboratories Co. Ltd. (MELCO) is an Iraqi company for
pharmaceutical drug industry. It was founded in Baghdad in 1989.
1.2 Activity and License:
MELCO have a valid Manufacturing License (No.3787), issued Iraqi
Ministry of Health for the manufacture of the following
pharmaceutical dosage forms:
- Tablets
- Hard capsules
- Oral solutions
- Topical solution
1.3 Outside Activity:
All products of MELCO are manufactured inside the company.
1.4 Important Information:
- Name of the company: MIDDLE EAST LABORATORIES CO. LTD.
- Address: Iraq – Baghdad –Ewadiah
- Phone: 07901911451, 07901911491
- E-mail : [email protected], [email protected]
MIDDLE EAST LBORATORIES CO. LTD. SITE MASTER FILE
BAGHDAD -IRAQ
2 | P a g e EFFECTIVE DATE 1/3/2013 REVISION NO. / 1
PREPARED BY REVIEWED BY APPROVED BY
CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
1.5 Types of Products:
- anti- inflammatory
- anti- histamine
- anti-septic
- expectorant
- non-steroidal anti- inflammatory
- antispasmodic
- anti- bacterial
- bronchodilator
1.6 Accommodation:
- Size: 2,114 square meter (45 X 46.6) meters
- 1st floor: management office, liquid department (syrup, suspension
and topical solution).
- 2nd floor: Q.C department, tablet and capsule department and gargle
department.
The factory has built up area 2,700 sq. meter. The connected power
capacity is 200 Kv and 350 Kv. The storage area is well maintained
and has air conditioning facilities to store drugs /products in a cool
place. RO Plant has capacity to produce 600 and 1200 lt. per hour for
Purified water on a continuous basis. The whole facility is well
maintained at all times with adequate and prompt repairs and paintings
and servicing.
MIDDLE EAST LBORATORIES CO. LTD. SITE MASTER FILE
BAGHDAD -IRAQ
3 | P a g e EFFECTIVE DATE 1/3/2013 REVISION NO. / 1
PREPARED BY REVIEWED BY APPROVED BY
CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
1.7 Number of Employees And Workers:
Pharmacists 3
Chemist 3
Biologist 1
Chemical Engineer 1
Mechanical Engineer 1
Business management 1
Technician 2
Workers 50
Distributor 1
Pursuer 1
1.8 Outside Relations
MELCO sometimes take assistance of outside analytical laboratories
for sophisticated test from (Ibn Senna Institution for Drug Research).
1.9 Quality Management:
1.9.1 Quality Policy
Middle East Laboratories Co. Ltd. has been established in accordance
with the Companies Law No. (36) for the year (1983) according to the
provisions of Article (21) of the Act above and subject to the
instructions of the Ministry of Health in Iraq and the Ministry of
Industry and Minerals in Iraq, which is always seeking since its
inception to manufacture medicines high quality and conformity to
specifications according to the constitutions of internationally
MIDDLE EAST LBORATORIES CO. LTD. SITE MASTER FILE
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PREPARED BY REVIEWED BY APPROVED BY
CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
approved medications in order to compete with pharmaceutical
products traded in the domestic and overseas markets and gain
customer satisfaction so as to enhance its position in the
pharmaceutical industry and are subject to the laws and regulations for
safety and environment while ensuring the safety of employees in the
company.
The senior management and all associate in the company works as a
team to ensure the appliance of the international standard operation
(ISO 9001:2008) and maintain the quality of the product through the
events of quality assurance and continuous improvement, in
accordance to the latest developments in the field the pharmaceutical
industry in the world to serve the increased production and lower
costs.
1.9.2 Description
The employees in the Division of Quality Management (Records,
Audit, measurement, analysis and improvement at the beginning of
each year start to develop an annual program that includes the
following:
• Planning monitoring and measuring processes: the company should
implement appropriate modalities to measure and control processes
system quality management and that these methods must explain the
MIDDLE EAST LBORATORIES CO. LTD. SITE MASTER FILE
BAGHDAD -IRAQ
5 | P a g e EFFECTIVE DATE 1/3/2013 REVISION NO. / 1
PREPARED BY REVIEWED BY APPROVED BY
CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
ability of these operations to reach the planned results. These
operations include:
- Sales, service and customer complaints
- Performance with regard to quality management system relating to the
product
• Self-Inspection Planning: (describe in details in section -9)
• Planning documentation processes: which includes, Application Form
(issue - edit - delete)
• Planning improvement: Are done through the activation of a
management review and action planning targets quality where senior
management review of quality management system in the time periods
planned to ensure the continued relevance and effectiveness, and by
reviewing the audit results.
MIDDLE EAST LBORATORIES CO. LTD. SITE MASTER FILE
BAGHDAD -IRAQ
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PREPARED BY REVIEWED BY APPROVED BY
CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
2. PERSONNEL
2.1 Organization Diagram
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PREPARED BY REVIEWED BY APPROVED BY
CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
2.2 Qualification
Name Qualification Occupation Experience
Mr. Hamdan Al Rawi B.Sc. PHARMA Managing director 46 Years
Mr. Ahmed Ali Ibrahim B.Sc. PHARMA Vice managing
director
46 Years
Mr. Sami Hamed B.Sc. PHARMA Registration
director
31 Years
Mr. Hasan Fadhil M.Sc. CHEMISTRY Q.A manager 8 Years
Mr. Saed Asaad M.Sc. CHEMISTRY Production
manager
5 Years
Mr. Saif Mohamad B.Sc. CHEMISTRY Production officer 5 Years
Ms. Marwa abed-Hussien B.Sc. E.CHEMISTRY Q.C manager 8 Years
Ms. Huda Abid-amir B.Sc. Biology Q.C officer 2 Years
Ms. Hawraa mohamed Business management
institution
Storage manager 3 Years
Mr. Zaid jalel Mechanical Engineer Maintain manager 7 Years
MIDDLE EAST LBORATORIES CO. LTD. SITE MASTER FILE
BAGHDAD -IRAQ
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PREPARED BY REVIEWED BY APPROVED BY
CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
2.3 Health Requirements
All persons engaged in production should be free from
infections and communicable diseases. In order to conform to
the above requirement, the following precautions are taken:
- Medical examination of all employees is done at periodic
intervals and not less than once annually, by a qualified Medical
Practitioner
- In addition to the above precautions, supervisors are always
required to keep watch for any signs of disease or weakness in
workers.
2.4 Personnel Hygiene Requirements
All employee that enter the manufacturing area should wear
protective clothing appropriate to the operation to be performed
where the working conditions imposed wear clothes (headscarf /
muzzle / gloves / robe industrial work the fewest number of pockets /
cover shoes / and goggles for the eyes).
Any employee has flu symptoms or cold or who have open wounds
not allowed to operate within production and must conduct medical
examinations periodically.
Eating or drinking, chewing gum and smoking are not allowed in
production areas and warehouse.
MIDDLE EAST LBORATORIES CO. LTD. SITE MASTER FILE
BAGHDAD -IRAQ
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PREPARED BY REVIEWED BY APPROVED BY
CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
3. PREMISES
3.1 Manufacturing Area
3.1.1 Tablet Manufacturing Diagram
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PREPARED BY REVIEWED BY APPROVED BY
CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
3.1.2 Liquid Manufacturing Area
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PREPARED BY REVIEWED BY APPROVED BY
CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
3.2 Nature of Construction
The manufacturing premise has RCC (reinforced concrete cement)
constructed with the following features in mind:
1. To prevent entry of insects and rodents.
2. With smooth interior surfaces free of cracks and crevices-in order to
allow easy cleaning and disinfection.
3. Adequate lighting facilities.
3.3 Ventilation System
The company maintains pressure differences among production
rooms in the same class as well as between different classes to
prevent cross contamination. The procedure is as follows:
A more negative pressure is applied into a dusty room than it is in the
corridor. A more positive pressure is applied to a less dusty room than
it is in the corridor.
MIDDLE EAST LBORATORIES CO. LTD. SITE MASTER FILE
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PREPARED BY REVIEWED BY APPROVED BY
CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
3.4 Water System
Potable water is transferred in to RO Plant for water purification
before pumped into RO Plant. The water in RO Machine is
transferred through sand filter and carbon filter to lessen dissolved
CO2, dissolved solids in water that could influence purified water
conductivity. The water is then pumped using High Pressure Pump
onto RO membrane. Purified water is distributed by sanitary pump
with minimal flow velocity of 1.5 m/s into the compounding tanks.
There is two RO plant one of 600 lit / hour and the other with 1200 lit
/ hour. An activated log book is held to record the pH, conductivity of
the purified water twice per a day.
4. EQUIPMENT 4.1 List of Equipment
(A) Weighing Room
S. Equipment Name Capacity
1 Weigh Balance 200 Kg
2 Weigh Balance 60 Kg
3 Weighing booth ----
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Dr. AHMED ALI Dr. HAMDAN AL RAWI
(B) Tablet Department
S. Equipment Name Capacity Quantity
1 Sifter 30 Kg 1
2 Rapid Mixer Granulator 60 Kg 1
3 Rapid Mixer Granulator 20 Kg 1
4 Trolley of FBD 60 Kg 2
5 Fluid Bed Dryer 60 Kg 1
6 Double Cone Mixer 800 L 1
7 Double Cone Mixer 280 L 1
8 Compression Machine 35 punches 1
9 Compression Machine 29 punches 1
10 Capsule filling machine 45,000 / hr. 1
11 Capsule De-Duster --- 1
12 Tablets De-Duster --- 1
13 Dust Collector --- 2
14 Coating Pan 60 Kg 1
15 Hot Air Blower --- 1
16 Spry Gun 1 liter 2
17 Exhaust --- 5
18 Blister Machine 100,000 / hr. 1
19 Blister machine 200,000/hr. 1
20 Water Cooler 100 liter 1
21 Compressor --- 2
22 De-blister machine --- 1
23 Colloidal Mill
MIDDLE EAST LBORATORIES CO. LTD. SITE MASTER FILE
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PREPARED BY REVIEWED BY APPROVED BY
CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
(C) Laboratory
S. Equipment Name Make Quantity
1 UV-VIS spectrophotometer Sunny 1
2 UV-VIS spectrophotometer Shimadzu 1
3 Digital pH meter WTW 2
4 Conductivity meter WTW 1
5 Friability tester Electrolab 1
6 Disintegration tester Electrolab 1
7 Tablet dissolution tester Electrolab 1
8 Bulk density tester Electrolab 1
9 Hardness tester Copley 1
10 Ultrasonic KLARY 1
11 Distillation system --- 1
12 Centrifugal 80-2 CE 1
13 Single pan balance / electronic Mettler 1
14 Single pan balance / electronic sartorus 1
15 Hot plate with magnetic stirrer BIBBY 1
16 Autoclave --- 1
17 Laminar flow LABTECH 1
18 Microscope Bausch & Lomb 1
19 High performance liquid chromatography Shimadzu 1
20 High performance liquid chromatography Knauer 1
21 Fourier Transform Infrared (F.T.I.R) Thermo 1
22 Vernier Mitutoyo 2
23 Water bath Gallenkamp 1
24 Oven WH-43 2
25 Refrigerator Ishtar 1
26 Desktop computer Dell 1
27 Laptop computer Acer 1
28 Incubator DH4000B 1
29 Incubator Al-Salih 1
30 Stability Chamber Osworld 4
MIDDLE EAST LBORATORIES CO. LTD. SITE MASTER FILE
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CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
(D) Syrup Department
S. Equipment Name Capacity
1 Compounding tank with stirrer and homogenizer 2000 liter X1
2 Compounding tank with stirrer and homogenizer 1000 liter X 4
3 Compounding tank with stirrer and homogenizer 600 liter X 2
5 Compounding tank with stirrer and homogenizer 500 liter X1
6 Compounding tank with stirrer and homogenizer 240 liter
7 Filling tank with stirrer 1000 liter X 3
8 Filling tank with stirrer 700 liter
9 Filling tank with stirrer 2000 liter X1
10 Colloid mill 300 liter / hour
11 Labeling machine 3000 bottles / hour X 3
12 Labeling machine 7000 bottles / hour X 2
13 1- nozzle filling machine / semi sealing machine bottles / hour
14 6- nozzle filling machine / Sealing machine 2500 bottles / hour X 3
15 7- nozzle filling machine / semi-sealing machine 1000 bottles / hour
16 8- nozzle filling machine / sealing machine 10000 bottles / hour
17 Cartooning machine 4000 bottles/ hour
18 Rotary bottle washing machine 5000 bottle / hour
19 Packet printing machine 3000 packet / hour X2
20 Leaflet machine 10000 leaflet / hour
21 Press filter 50 liter X2
22 Shrink machine / manual ---
4.2 Preventive Maintenance
Administrator and maintenance during the execution of daily work
and when there is a need to withdraw a protective reaction form and
fill out this form of agreement with the quality control department
officials so as to include a preventive determine the type and time of
implementation in accordance with the form above. As well as
requests are raising preventive actions to direct manager for approval.
MIDDLE EAST LBORATORIES CO. LTD. SITE MASTER FILE
BAGHDAD -IRAQ
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PREPARED BY REVIEWED BY APPROVED BY
CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
4.3 Sanitation
Cleaning and Sanitation activities are implemented according to
Sanitation SOP. They are grouped into cleaning and sanitation of
(machine, room, processing tool). Sanitation material used, cleaning
agent, disinfectant, cleaning agent, disinfectant are changing
frequency. Outside of building is also daily cleaned. The walls, roof,
gates and doors of building are periodically maintained and cleaned.
Detail of working steps is recorded in SOP for routine sanitation
implementation, and every sanitation personnel should follow the
SOP.
5. DOCUMENTATION
5.1 The documents are prepared and formulated clearly and accurately by
company officials who implement and oversee production operations,
maintenance and quality control and the Administration Department
and Quality Management to match the steps contained in the standard:
ISO 9001:2008.
5.2 Control quality management system documentation includes:
- Upon receipt of the documents that have been reviewed and approved
by the managing director of the company and a representative of the
administration official documents is stamped with a blue color seal at
the back of each document and is considered an original document and
stored in the Documentation Division.
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Dr. AHMED ALI Dr. HAMDAN AL RAWI
- The official of documents filmed the copies needed for distribution by
the required number in the list of controlled documents and controls
the seal of the face of each page with green stamped color and is
considered a controlled document.
5.3 Request (issue - edit - delete) and new documents, which includes:
- Shows the request for quality management department for the purpose
of audit and express an opinion and then presented to the
representative of the administration to take the appropriate decision.
- The official of documents withdraws the old copies from the places of
use and distribute the new issue instead of the modified documents
and damaged the old copies and keep one copy (original copy) of the
canceled documents in a special file (Canceled Documents File) and
stamped the face of the front page with the seal of red color and is
considered a canceled document.
5.4 The master batch record contains:
- Dispensing raw material form
- Processing batch record
- Certificate of chemical analysis issued by Q.C department
- Certificate of biological analysis issued by Q.C department
- SOP of cleaning the compounding room
- In-process control
MIDDLE EAST LBORATORIES CO. LTD. SITE MASTER FILE
BAGHDAD -IRAQ
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PREPARED BY REVIEWED BY APPROVED BY
CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
6. PRODUCTION
6.1 Description Of Production Plan
Every process flow has process-points that describe process detail,
(SOP). It also has inspection-points that explain inspection detail and
inspection implementation by person in charge. The process flow is
divided into several steps, such as material receiving step, dispensing
the raw materials, compounding process, filling, sealing, labeling,
packing and finished product delivery step. Every step will go
through inspection process according to acceptance criteria
determined by QC Department.
The flow chart of production for tablet and syrup department is shown
in section (3.1.1 and 3.1.2) respectively.
6.2 Handling Of Raw Materials
Upon receipt of the raw materials/packing materials, the material is
unloaded on the receiving bay. The correctness of the material
received is checked with the delivery note. Supplier’s batch number
and the quantities are cross verified.
Sampled containers are labeled with a yellowish orange “UNDER
TEST LABEL”, the label indicates name of the material, batch
number of the supplier, analytical report number, and date of
manufacturing, date of expiry If the sample complies with the
approved specifications, “An APPROVED LABEL” in green is
pasted and if it does not meet the specifications, a red “REJECTED”
label is pasted on the containers.
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CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
6.3 Production Process
SOP is followed for all manufacturing and packing operations.
Identity of materials at processing stage is confirmed by reading
dispensing labels. Weights are counter checked. The dispensed raw
materials are processed as per the instructions defined in the product
specific batch manufacturing record. Processing activity is
implemented according to process stage flow of each type of product
and master batch record documentation.
6.4 In-Process Inspection
In-process control/ tests are carried out as per the frequency and
procedure defined in product specific batch records. In-process
checks are conducted by Production and the Quality assurance,
independently at defined intervals. QC department is responsible for
testing and releasing implementation in production process.
6.5 Finish Product
Intermediate products are analyzed and approved by the Quality
control prior to the packing operation. The goods are released for
dispatch after the completion of the finished product analysis and the
review of the batch documents and the analytical reports by Quality
assurance. Products released by Quality Assurance are transferred to
the approved finished product storage area.
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CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
6.6 Handling The Rejected Materials And Products
Rejected product or material is identified clearly and place in separate
location to prevent unwanted/ accidental usage.
- If raw material is not conforming to the specifications, it is labeled
“REJECTED” and is isolated and it is sent back to the vendor.
- If printed packing material is rejected, it is isolated and destroyed at
the site in the presence authorized persons.
- If any intermediate or finished product is found to be non-conforming,
it is isolated and marked with the appropriate label. It is then referred
to the Manager Quality Assurance, who investigates the problem.
6.7 General Policy For Validation Process
6.7.1 The Prospective Validation: Prospective validation
conducted for 3 continuous batches where the validation result comply
all specification of (In house, USP and BP).
6.7.2 Revalidation Policy:
- One batch of each product every year.
- Qualified equipment undergoes major modification, replacement of
critical spares that shall affect equipment performance.
- Location of equipment is changed.
- Change of cleaning agent/ method.
- Process/ Formula Change.
- Change of any critical equipment in the chain of equipment used for
product Manufacturing.
- Change in analytical method.
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CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
7. QUALITY CONTROL
Quality control department have experienced, competent and
technically qualified personnel to take on various activities of the
department.
Quality control is responsible for sampling and analysis as per
approved specifications. Release/reject authority for all raw materials,
packing materials, intermediate products and finished products lies with
quality control only, but final release authority for product lies with Quality
assurance.
The laboratory has been designed and equipped with facilities for
chemical, microbiological analysis. Microbiological area is provided with
laminar airflow and other facilities to carry out limit tests, assays, water
testing and environment monitoring.
All volumetric solutions used in assays and other tests are prepared
from material of a suitable grade in accordance with the approved
procedures. Containers holding volumetric solutions are labeled with details
like name of the solution, strength of solution, date of preparation, and the
initials of the person who prepared the solution.
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CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
8. DISTRIBUTION, CUSTOMER COMPLAINTS AND RECALL
8.1 Distribution
Distribution in the Middle East includes two types:
1 - Private sector: where direct contact with customers is held and
their requests are recorded and sent to stores.
2 - Kimadia: The distribution form in contract terms to be agreed on
quantities, prices and delivery schedule. The products are shipped by
refrigerated vehicles.
8.2 customer complaints and recall system
As soon as the product/batch to be recalled is/are identified, licensee
or representative of licensee or QA in charge shall review the
information related to the defective product/batch and decide about
recall as per the procedure established.
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Dr. AHMED ALI Dr. HAMDAN AL RAWI
9. SELF-INSPECTION SYSTEM
9.1 The self-inspection incorporate productivity has three forms:
9.1.1 Checking the quality of the system: is a valuation of the quality
management system adopted in the company.
9.1.2 Checking the quality of operations: a valuation of the quality of
operations directly related to manufacturing.
9.1.3 Checking the quality of the products: a valuation of the quality
of finished products in order to access to information showing
the extent of compliance with the required specifications and
suitability for use
9.2 The self-inspection activities:
The director of quality management to develop a plan to audit includes
all activities necessary, status checklist for internal audit quality. Where
the action form of corrective or preventive is initialized and handed over
to the auditors so that these models are filled for each case that need to
act preventive or corrective.
Checker in the final stage displays the results of the audit and informed
and agreed on the applications of most effective corrective or preventive
and provided a copy of the requested corrective actions or preventive to
the auditor upon by the director of quality management and saved the
originals with Director of Quality to follow implementation of agreed
actions.
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CHEMIST HASAN FADHIL
Dr. AHMED ALI Dr. HAMDAN AL RAWI
10. List Of Products
S. Brand Name Generic Name and Strength
1 Actimel Syrup Triprolidine HCl
Pseudoephedrine HCl
2 Antusin Syrup Dextromethorphane HBr
Chloropheneramine maleate
3 Cyprodine Syrup Cyprohepatadine HCl
4 Ketofen Syrup Ketotifen (as hudrogen Fumarate)
5 Poramine Syrup Chloropheneramine maleate
Menthol
6 Ventomel Syrup Salbutamol
7 Quibrophylline Syrup Anhydrous theophylline
Guiaphenesin
8 Dexamethasone Elixir Dexamethasone
9 Flagimel Suspension Metronidazole benzoate
10 Ponstamel Suspension Mefenamic acid
11 Brufemel Suspension Ibuprofen
12 Povidon Iodine solution
10%
Povidone iodine 10 % w/v
13 Povidon Iodine solution
7.5%
Povidon Iodine 7.5 % w/v
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14 S.S.Lotion Selenium sulfide
15 Duspatamel 135 Tablet Mebeverine HCl
16 Sulfatrime Tablet Sulfamethaxazole 400mg
Trimethoprim 80 mg
17 Enalapril 5 Tablet Enalapril maleate 5 mg
18 Enalapril 10 Tablet Enalapril maleate 10 mg
19 Enalapril 20 Tablet Enalapril maleate 20 mg
20 Flagimel 250 Tablet Metronidazole 200 mg
21 Flagimel 500 Tablet Metronidazole 500 mg
22 Cyprodine Tablet Cyproheptadine HCl 2 mg
23 Tenoximel Capsule Tenoxicam 20 mg
24 Fungistat solution 1% Clotrimazole 1%
25 Erythroderm topical
solution 2%
Erythromycin 2%