2. IDEAL PHARMACEUTICAL FACILITY PRESENTED BY: IHSAN ULLAH KHAN KHATTAK Chief Manager Production Highnoon Laboratories Limited 17.5 K.M. Multan Road, Lahore, Pakistan. khattak@highnoon.com.pk

3. WORLD CLASS PHARMACEUTICAL FACILITY WHAT IS THE NEED?

4. WORLD CLASS PHARMA MANUFACTURING FACILITY PRESENT SCENARIO : The Globalization & Open Market Policy has proved to be a boon for the industries, but has generated need for a globally acceptable manufacturing facility. There are many flourishing manufacturing facilities, but not all are in compliance with the various regulatory standards.

5. WORLD CLASS PHARMA MANUFACTURING FACILITY NEED: FOR A FACILITY Rapid change in manufacturing technology & various regulatory compliances to upgrade for better solution in line with cGMP. With globalization, the need for compliant facility has become a statutory necessity.

6. WORLD CLASS PHARMA MANUFACTURING FACILITY PRESENT SCENARIO: Many existing facilities have ; Inadequate process layout. Inadequate space. Inadequate hygiene & sanitary conditions. Inadequate HVAC system Inadequate utilities layout

7. WORLD CLASS PHARMA MANUFACTURING FACILITY DESIGN TYPES OF MANUFACTURING FACILITY A.NEW FACILITY -Dedicated premises -Multi product facility B. UPGRDATION OF EXISTING FACILITY -Modernization -Extension -Expansion

8. WORLD CLASS PHARMA MANUFACTURING FACILITY Components of Facility: -Shipping / Receiving -Warehouses -Manufacturing Plant -Packaging Areas -Quality Operations -Office Block -Utilities Floor

9. WORLD CLASS PHARMA MANUFACTURING FACILITY DESIGN ISSUES Basic Criteria, -Prevention of Cross contamination -Processing of multiple products concurrently. -Ensure integrity of final product -Unidirectional flow

10. WORLD CLASS PHARMA MANUFACTURING FACILITY Architectural Design Process Programming Phase Problem Seeking Design Phase Problem Solving Documentation Phase Construction Phase Implementation Validation

11. WORLD CLASS PHARMA MANUFACTURING FACILITY SOME IMPORTANT PARAMETERS -LAYOUT -HVAC DESIGN -WATER SYSTEM -AUTOMATION -TYPE OF TECHNOLOGIES

12. WORLD CLASS PHARMA MANUFACTURING FACILITY HVAC Design and Monitoring - Need -First cost is about 20% of the project cost. -Energy consumption is very high about 40% load is HVAC. -Validation cost is very high. -Maintenance cost is very high -Skilled manpower -Hidden variables -Improper air management -Classification of the areas, temperature and RH -Pressure Differential, air distribution

13. WORLD CLASS PHARMA MANUFACTURING FACILITY Water Management -Potable Water -Purified Water -WFI -Generation and distribution

14. WORLD CLASS PHARMA MANUFACTURING FACILITY Project Team -Plant Manager -Mechanical Engineer -Project Engineer -Logistics Engineer -Civil Engineer -Highly Skilled Consultant A smaller team is definitely a better team.

15. WORLD CLASS PHARMA MANUFACTURING FACILITY Incomplete Design -Incorrect piping size -Incorrect wiring -Missing Signal Feeds -Incorrect power supply -Under capacity AHUS -Over capacity AHUS -Improper dehumidification -Improper process flow These are few common mistakes.

16. WORLD CLASS PHARMA MANUFACTURING FACILITY Proper Layout Design Some common mistakes; - Under / over designing of areas. -No provision for waste disposal -Inadequate service areas -Under / over capacity warehouses -Insufficient Holding areas

17. WORLD CLASS PHARMA MANUFACTURING FACILITY Cross Contamination Can be Prevented by : -Proper Layout -Proper Area Classification -Proper HVAC Design -Correct Man & Material Flow -Proper Air Distribution -Skilled Manpower -Technical Awareness.

18. WORLD CLASS PHARMA MANUFACTURING FACILITY Future Requirements : -Space -Machine Capacities -Utility Design -Durable Civil Work -Modular Structures -Flooring -Expansion of Product Mix

19. WORLD CLASS PHARMA MANUFACTURING FACILITY Proper Communication : -Communication is the key to success as it is not an ancient oriental philosophy or even recently developed success habit, but a well documented but often over looked fact of project team.

20. WORLD CLASS PHARMA MANUFACTURING FACILITY Operating Cost Criteria : -Selection of right Technology -Right Equipments -Right Utilities -Right Vendors -Right Time Management -Commitment

21. WORLD CLASS PHARMA MANUFACTURING FACILITY Summation : -Ready to use solutions for Pharmaceutical plant do not exist because user requirement such as product design and quantities, production process vary from case to case. -Thus pharmaceutical plants cannot be taken off the shelf.

22. Thank You