SUPAC.pptx
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The document discusses SUPAC (Scale Up and Post Approval Changes) documents issued by the FDA to guide applicants on post-approval manufacturing changes. It introduces SUPAC documents for immediate and modified release products and describes how they categorize different types of changes, such as to components, manufacturing processes, batch size, and sites. Quality assessment of pharmaceutical products involves various scientific fields including pharmaceutical engineering, chemistry, and pharmacology.
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The document summarizes a fluidized bed dryer. It works by fluidizing wet solid particles using hot air forced through a perforated bed from the bottom. The dryer is made of stainless steel or plastic with a detachable bowl for charging and discharging materials. Hot air is circulated through the bed to dry particles completely before exiting through bag filters. It allows for continuous, rapid drying at a constant rate with high efficiency and capacity compared to other dryers. Pharmaceutical uses include drying granules for tablet production and granule coating.
SPRAY DRYER
Spray drying is an industrial process that transforms a liquid feed containing dissolved or dispersed solids into a spray of small droplets that are exposed to hot air to be dried. It allows for effective control of product quality and properties during continuous high-tonnage production. While spray dryers are bulky and expensive, they permit thermolabile pharmaceuticals to be dried at low temperature and are used to dry products like penicillin, enzymes, and vaccines.
Drum Dryer
The document describes a drum dryer, which consists of one or two horizontally mounted hollow cylinders or drums that are heated internally by steam and rotated. Liquid or slurry is spread as a film onto the heated, rotating drum surface where it dries rapidly via conduction and steam heating. The dried material is then scraped off and collected while the drum continues rotating. Drum drying allows for rapid drying of thermosensitive materials in a compact system, though it requires careful control of processing parameters and has high maintenance costs.
tray drayer.pptx
The tray dryer uses forced hot air convection to remove moisture from solids placed on stainless steel trays. It has double-walled insulation and doors with gaskets. Hot air is blown through the chamber at 2-5 meters per second to evaporate water from the surface of the solids on each tray, which are loaded and unloaded batch-wise. Tray dryers are efficient, require little labor, and are available with capacities from 6 to 192 trays.
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Skin is the largest organ of the human body, serving crucial functions that include protection, sensation, regulation, and synthesis. Structurally, it consists of three main layers: the epidermis, dermis, and hypodermis (subcutaneous layer).
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2. **Dermis**: Located beneath the epidermis, the dermis contains connective tissue, blood vessels, hair follicles, and sweat glands. It plays a vital role in supporting and nourishing the epidermis, regulating body temperature, and housing sensory receptors for touch, pressure, temperature, and pain.
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Gastrointestinal Infections
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- 1. SUPAC •SCALE UP AND POST APPROVAL CHANGES
- 2. • What are SUPAC documents • Key SUPAC documents for quality assessment (FPPs) • Basic uses of SUPAC documents • Introduction to SUPAC IR guidance ► Main document ► Equipment addendum • Examples
- 3. QUALITY ASSESSMENT Manufacturing sciences Pharmaceutical engineering/pharmaceutical technology (production methods and systems, facilities, equipment, etc.) Pharmaceutical sciences Chemistry (organic, inorganic, physical, biochemical, analytical (e.g. methodology, validation, spectral analysis)) Pharmaceutical chemistry (study of drug design) Pharmaceutics (study of drug formulation) Pharmacognosy (study of drugs of natural origin) Other fields: Math/statistics, microbiology, GMP
- 4. A series of documents issued by US FDA (CDER) to help applicants with post-approval changes • Documents are categorized into IR, MR and SS (FPPs) • Various types of changes are described: ►Components and composition ► Manufacturing (equipment, process) ► Batch size ► Manufacturing site changes
- 5. • SUPAC IR (immediate release) • SUPAC MR (modified release) • SUPAC IR/MR equipment addendum • SUPAC IR Q&A • SS: Non sterile semi-solids + equipment addendum
- 7. Determining the importance of various changes: SU: scale-up during original dossier assessment Consider changes made after the biobatch ► Components and composition ► Manufacturing (equipment, process) ► Batch size ► Manufacturing site changes