Different Sections in Pharmaceutical Formulations Facility

This article describes about Different Sections In the Pharmaceutical Formulations Facility :

Different Sections in Pharmaceutical Formulations Facility.

Warehouse :

1. Raw Material Store
2. Packing Material Store
3. Finished Goods Store

Oral Solid Dosages :

Tablet :

1. Dispensing area
2. Granulation
3. Compression
4. Coating
5. Packing

Capsule :

1. Dispensing area
2. Granulation/Blending
3. Capsule Filling
4. Packing

External Preparations :

1. Dispensing / Tube Decartoning area
2. Manufacturing Area
3. Tube filling Area
4. Tube Packing area

Dry Powder Injections :

1. Decartoning Area
2. Washing/Autoclaving area
3. Sterilization and Depyrogenation
4. Filling and Bunging area
5. Sealing Area
6. Labelling Area
7. Packing Area

Quality Control:

1. Raw material section
2. Packing material Section
3. Inprocess Testing section
4. Finished product Testing section
5. Water Testing
6. AMV/AMT section if any
7. Stability Section
8. Instrument Calibration Section
9. Documentation (Preparations or revision of STP/Spec/QMS/SOP)

Microbiology :

1. Culture/Media Handling
2. Incubator Handling and maintenance
3. MLT (Microbial Limit Testing)
4. Water Testing
5. Environmental Monitoring
6. Sterility and BET – Bacterial Endotoxin Test (For Injection)

Quality Assurance :

1. IPQA
2. QMS
3. Validations
4. APQR
5. BMR/BPR preparations & Issuance
6. Regulatory compliance documentations
7. Vendor Qualifications/Approvals
8. General documentations Upkeepment

Engineering :

1. Water System
2. Utility (Air Compressor, Boiler, Chiller/DX, HVAC)
3. ETP

Research and Development :

1. F&D (Formulation and Development)
2. ADL (Analytical Development Laboratory)
3. Stability