royal link pharma
TRANSCRIPT
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بسم هللا الرحمن الرحيم
Welcome
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The Factory Inspected and Approved from Egyptian Ministry of Health at 6/2008
Factory Approved
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Factory Organgram
Factory Manager
QC Dept. Production Warehouse Planning R&D ENG.
AdministrationQA Dept.
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Factory Organgram
Qualtiy Control Dept.
StabilityFnished Product
Inspection
Packaging Mat.
Inspection
Raw Mat.Inspection
Microbiology & Environment
Section
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QA Section
QA Doc.& Invest. Training Officer In Process ControlInternal & External Auditing
Factory Organgram
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Manufacturing Facilities:
Royal Link Pharma manufacturing facilities have been designed and built to meet all major international standards and regulations: -- cGMP - WHO- FDA- European Union (EU)- Dedicated production and quality control facilities, which are completely separated from multipurpose manufacturing facilities
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Factory Location
FactoryG 21, Industrial Zone 1, Gamasa, Dkahliya, Egypt
Tel: +2050 2770056/ +2050 2770057/ 2050 2334578 Mansoura Office
Yasmeen tower, 1 alazly St, qnat elswees St, Mansoura, DakahliaFax: +2050 2770058/ +2050 2318142
Cairo Office32 D, Al-obour buildings, Salah Salim St., Cairo, Egypt
Tel: +202 22613372 Fax: +2 02 21631914
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Royal Link Pharma
FactoryG 21, Industrial Zone 1, Gamasa, Dkahliya, Egypt
Capital :a bout 150 million LE
Size:a bout 9000 meters square
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H V A C SYSTEMINFRASTRUCTURE
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H V A C SYSTEMINFRASTRUCTURE
Royal Link Pharma separates the Air Handling System into 4 grades of class (based on EU GMP), which are:Grade B –LAF 100 , Background (Class 10.000) For example: microbiology lab.Grade C (Class 10.000): required for less critical process. Ex:Liquid preparation , filing. Filing area of External use ,Cream preparation & filing3. Grade D (Class < 100.000): required for non sterile process. Ex: Dispensing and sampling Room .4. Grade E (Class < 1000.000): required for packaging and warehouse process.
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HEAT, VENTILATION AND AIR
CONDITIONING SYSTEM [HVAC]
Air Conditioning:Air handling units for production and warehouse areas are equipped with adequate control over dust, temperature and humidity.Every department has its own separate system for air handling.Fresh air is controlled and supplied to the system through sand traps.Exhaust fans are used in toilets, showers and equipment washing area to prevent reticulating air from these areas.
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WATER SYSTEM
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Highly Purified water is supplied continuously by Positive pressure for all production areas, special plumbing system is used to prevent contamination to the product.
All drainages outlets in production areas are provided complete with antisiphonic devices to prevent back flow.
WATER SYSTEM
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Main Assemblies
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Royal Link Pharma
An oil free, filtered and dry compressed air is provided for all production and services areas.
ELECTRIC SYSTEM:Is providing a sufficient power for all different loads requirements.
COMPRESSED AIR
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Royal Link Pharma
All rooms are furnished with detectors suitable to room function, and exit doors are equipped by manual call points. The system is controlled and monitored by main panel and repeater.
FIRE FIGHTING SYSTEM:The building is furnished a water fire fighting system C/W fire hydrants and hose rails, also portable fire extinguishers are available in all areas.
FIRE ALARM SYSTEM:
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Our Production Lines
Capsules Liquids Semi solid Tablets Veterinary External Use
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Capsules filing
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Liquids Preparation
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Liquids Filing and packaging
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Soiled Dosage Form Preparation
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Tablets Manufacturing
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Semi solid ( creams & ointments)
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QUALITY CONTROL
Quality Control is independent of productionAll the incoming materials are sampled in accordance with a pre-set sampling plan and are given a unique analytical reference number
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QUALITY CONTROL
Equipment Name Place
Spectrophotometer.
Instrumental Lab.
Analytical Lab.
Karl-Fisher
Polari meter
Refracto meter
HPLC.
Friability Tester
pH-meter (with electrode).
Melting Point apparatus
Disintegration test apparatus.
Dissolution test apparatus
Conductivity.
PH-meter ..
3 Incubator
Microbiology Lab.Autoclave
LAF
Air Sampler
Colony counter
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QUALITY CONTROL EQUIPMENTS
Complete analysis is performed on input materials,
intermediates and finished products using classical
analytical "wet chemistry" techniques as well as
sophisticated instrumentation such as HPLC and
UV/VIS spectrophotometers.
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Microbiological Testing
The laboratory is also provided with the necessary
equipment including incubators, laminar airflow
units, etc. to handle.
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Environmental Monitoring
Air ,water and personals under go routine
microbiological testing to assure that the air and
the water meet the quality requirements
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Product Stability
Stability of our products under different environment
conditions is one of our main concerns.
All Stability studies are carried out according to International
conference on Harmonization (ICH) guideline.
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Documentation
DOCUMENTS SYSTEM INCLUDE THE FOLLOWINGQuality PolicyQuality ManualStandard Operating ProceduresTechnical ProceduresTraining proceduresCleaning procedures Quality Control procedures Validation documents
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Documents System Include The Following
Calibration documents Storage proceduresMaster manufacturing formulaBatch manufacturing recordBatch packing record specificationsStandard operating procedures covering general procedures and methods
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Equipment Qualification And Calibration
Calibration documents Storage proceduresMaster manufacturing formulaBatch manufacturing recordBatch packing record specificationsStandard operating procedures covering general procedures and methods
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Equipment Qualification And Calibration
Validation studies as per protocol are carried out.All new equipment are subjected to installation and qualification evaluations before being put into regular use.Prequalification assessments are also carried out for any major modifications to exiting equipment.Equipment calibration is done at regular intervals.
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Handling Of Materials
Only starting materials which have been released by QC and which are within the retest period are used.
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Handling Of Rejected Materials And Products
Rejected materials and products are clearly marked and stored separately in a segregated area.
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Distribution
All finished products are stored under appropriates storage conditions after QA approval.The products are released for dispatch to the Company’s sales depot. The goods are then distributed to the market .
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Products Categories
HerbalProducts
PharmaceuticalProducts
CosmeticsProducts
VeterinaryProducts
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Thanks….