www.royallinkpharma.com

1. بسم الله الرحمن الرحيم
Welcome

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

4. Factory Organgram
Factory
Manager
Administration
QA Dept.
QC Dept. Production Planning Warehouse R&D ENG.

5. Factory Organgram
Qualtiy Control Dept.
Stability
Fnished Product
Inspection
Packaging Mat.
Inspection
Raw
Mat.Inspection
Microbiology &
Environment
Section

6. QA Section
QA Doc.& Invest. Training Officer Internal & External In Process Control
Auditing
Factory Organgram

7. 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

8. Factory Location
Factory
G 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, Dakahlia
Fax: +2050 2770058/ +2050 2318142
Cairo Office
32 D, Al-obour buildings, Salah Salim St., Cairo, Egypt
Tel: +202 22613372 Fax: +2 02 21631914

9. Royal Link Pharma
Factory
G 21, Industrial Zone 1, Gamasa, Dkahliya, Egypt
Capital :
a bout 150 million LE
Size:
a bout 9000 meters square

10. H V A C SYSTEM
INFRASTRUCTURE

11. H V A C SYSTEM
INFRASTRUCTURE
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 & filing
3. 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.

12. 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.

13. WATER SYSTEM

14. 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.

15. Main Assemblies

16. Royal Link Pharma
COMPRESSED AIR
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.

17. Royal Link Pharma
FIRE ALARM SYSTEM:
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.

18. Our Production Lines
Capsules Liquids Semi solid Tablets Veterinary External Use

19. Capsules filing

20. Liquids Preparation

21. Liquids Filing and packaging

22. Soiled Dosage Form Preparation

23. Tablets Manufacturing

24. Semi solid ( creams & ointments)

25. QUALITY CONTROL
Quality Control is independent of production
All the incoming materials are sampled in accordance with a pre-set sampling plan and are given a unique
analytical reference number

26. 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

27. 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.

28. Microbiological Testing
The laboratory is also provided with the necessary
equipment including incubators, laminar airflow
units, etc. to handle.

29. Environmental Monitoring
Air ,water and personals under go routine
microbiological testing to assure that the air and
the water meet the quality requirements

30. 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.

31. Documentation
DOCUMENTS SYSTEM INCLUDE THE FOLLOWING
Quality Policy
Quality Manual
Standard Operating Procedures
Technical Procedures
Training procedures
Cleaning procedures
Quality Control procedures
Validation documents

32. Documents System Include The Following
Calibration documents
Storage procedures
Master manufacturing formula
Batch manufacturing record
Batch packing record
specifications
Standard operating procedures covering general procedures and methods

33. Equipment Qualification And Calibration
Calibration documents
Storage procedures
Master manufacturing formula
Batch manufacturing record
Batch packing record
specifications
Standard operating procedures covering general procedures and methods

34. 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.

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

36. Handling Of Rejected Materials And Products
Rejected materials and products are clearly marked and
stored separately in a segregated area.

37. 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 .

38. Products Categories
Herbal
Products
Pharmaceutical
Products
Cosmetics
Products
Veterinary
Products

39. Thanks….