1. REGULATORY REQUIREMENTS INVOLVED IN SOLIDS,LIQUIDS.

2. SOLID DOSAGE FORMS
GENERAL CONSIDERATIONS ♪ Dust Control and Cross Contamination, ♪ Environmental Conditions, ♪ Contamination, ♪ Material Lodging, ♪ Vacuum , Air Extraction Nozzles

3. MANUFACTURING PROCEDURES
MIXING,GRANULATION:
♪Residues from sieving to be examined periodically
♪Operating parameters to be specified in a master formula
♪Granulation and coating solutions shall be avoided from the risk of contamination

4. COMPRESSION Dust control facilities
Examination at fixed intervals of time
Rejected or discarded tablets to be isolated
Evaluation tests

5. COATING
Coating solutions shall be made afresh which shall minimize the risk of microbial growth
Air supplied to coating pans for drying purposes shall be filtered air and of suitable quality

6. MANUFACTURING PROCEDURES
FILLING(CAPSULES)
PRINTING(TABLETS,CAPSULES)
PACKAGING

7. Manufacturing equipment
Coating Equipment
Test Results
Product Failures
Site Review

8. LIQUID DOSAGE FORM BUILDING
♪Layout and design of manufacturing area shall strive to minimise cross contamination
♪The production area shall be cleaned and sanitised at end of every production process
♪The furniture used should be smooth and made of stainless steel

9. LIQUID DOSAGE FORMS PURIFIED WATER
The chemical and microbiological quality of purified water shall be specified and monitored routinely
There shall be written procedure for operation and maintenance of the purified water system

10. MANUFACTURING
Materials likely to shed fibre like gunny bags , wooden pallets shall not be carried into the area where products are exposed
Manufacturing personnel should wear non-fibre shedding clothing to prevent contamination
The primary packaging area have an air supply which is filtered through 5 micron filters

11. LIQUID DOSAGE FORMS
Liquid dosage forms commonly encountered in pharmaceutical practice are either monophasic or biphasic.
Monophasic systems are characterized by the presence of a single homogeneous phase e.g., solution, mixtures, elixirs, tinctures, syrups, ear drops, nasal drops, etc., whereas biphasic liquid dosage forms consist of two distinct phases e.g., emulsions and suspensions.

12. PARENTERALS WATER MANAGEMENT AREA 1: De-ionised water treatment unit,
2: Distillation unit;
3: Thermostatically controlled water storage tank;
4: Transfer pumps(service lines for carrying water into user areas)

13. CONTAINERS,CLOSURES PREPARATION AREA
Automatic closures washing machine
Storage equipment for ampoules,vials,bottles etc
Dust proof storage cabinets
Stainless steel benches or stools
Glass , plastic

14. SOLUTION PREPARATION AREA
Solution preparation and mixing stainless steel tanks and other containers
Portable stirrer
Filtration equipment with filters(membranes with porosity ratings0.22 or 0.45 are usually specified for sterile filtration)
Transfer pumps
Stainless steel benches

15. FILLING,CAPPING,SEALING AREA
Automatic ampoule/vial filling , sealing , capping machine under laminar air flow work station
Gas lines (nitrogen ,oxygen , carbon dioxide) wherever required

16. STERILIZATION AREA Steam sterilizers(with computer control)
Hot air sterilizer
Pressure leak test apparatus
Gas or vapour sterilization

17. QUARANTINE AREA
Storage cabinets
Raised platforms/steel racks

18. PACKAGING AREA
Batch coding machine ( automatic)

19. REFERENCES https://docs.google.com http://www.fda.gov/ICECI

20. THANKU