بسم هللا الرحمن الرحيم

Welcome

The Factory Inspected and Approved from Egyptian Ministry of Health at 6/2008

Factory Approved

Factory Organgram

Factory Manager

QC Dept. Production Warehouse Planning R&D ENG.

AdministrationQA Dept.

Factory Organgram

Qualtiy Control Dept.

StabilityFnished Product

Inspection

Packaging Mat.

Inspection

Raw Mat.Inspection

Microbiology & Environment

Section

QA Section

QA Doc.& Invest. Training Officer In Process ControlInternal & External Auditing

Factory Organgram

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

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

Royal Link Pharma

FactoryG 21, Industrial Zone 1, Gamasa, Dkahliya, Egypt

Capital :a bout 150 million LE

Size:a bout 9000 meters square

H V A C SYSTEMINFRASTRUCTURE

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.

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.

WATER SYSTEM

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

Main Assemblies

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

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:

Our Production Lines

Capsules Liquids Semi solid Tablets Veterinary External Use

Capsules filing

Liquids Preparation

Liquids Filing and packaging

Soiled Dosage Form Preparation

Tablets Manufacturing

Semi solid ( creams & ointments)

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

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

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.

Microbiological Testing

The laboratory is also provided with the necessary

equipment including incubators, laminar airflow

units, etc. to handle.

Environmental Monitoring

Air ,water and personals under go routine

microbiological testing to assure that the air and

the water meet the quality requirements

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.

Documentation

DOCUMENTS SYSTEM INCLUDE THE FOLLOWINGQuality PolicyQuality ManualStandard Operating ProceduresTechnical ProceduresTraining proceduresCleaning procedures Quality Control procedures Validation documents

Documents System Include The Following

Calibration documents Storage proceduresMaster manufacturing formulaBatch manufacturing recordBatch packing record specificationsStandard operating procedures covering general procedures and methods

Equipment Qualification And Calibration

Calibration documents Storage proceduresMaster manufacturing formulaBatch manufacturing recordBatch packing record specificationsStandard operating procedures covering general procedures and methods

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.

Handling Of Materials

Only starting materials which have been released by QC and which are within the retest period are used.

Handling Of Rejected Materials And Products

Rejected materials and products are clearly marked and stored separately in a segregated area.

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 .

Products Categories

HerbalProducts

PharmaceuticalProducts

CosmeticsProducts

VeterinaryProducts

Thanks….