Technology transfer is both integral and critical to drug discovery and development process for new medicinal drug products. A major decision focuses on that point where the idea or process is advanced from a research-oriented program to targeted toward commercialization. Generally, the cost of product development rises dramatically during the pilot scale-up and initial production … Read more
Alternate Vendor development for existing material shall be initiated through the Change control procedure. Supply chain / purchase team on its own or on the recommendation of Technology Transfer team / R&D / Production shall identify the vendor for existing material. Supply Chaim (SCM) / purchase Team shall initiate queries with the prospective vendors for … Read more
Blending in its simplest form is the combining of two or more materials to produce a homogeneous mixture. These materials may be any combination of particulate (solids blending) or particulate and liquid (liquid-solid blending). Normal tumble blending of free-flowing materials provides a gentle mixing action. For materials that tend to lump or for high intensity … Read more
Homogenous mixing of dry & wet powders, de-agglomeration / de-lumping of wet mass and fast dispersion of binding agent. Dust free, high free flowing dosing particles, high uniformity of granule size. AC frequency control for bottom driven Impeller Mixer with 3 or 4 blades with exclusive scrape side design and Chopper positioned to make granules. … Read more
Fluid Bed Dryers (FBD) are primarily used in almost all chemical, pharmaceutical, food, dyestuff and other process industries to dry materials by fluidization with hot and / or dehumidified air, which creates a turbulence in the wet product (not totally liquid) while flowing through it. WORKING PRINCIPLE: The atmospheric air is sucked in the dryer … Read more
VIBRO SIFTER, VIBRO SCREEN: Vibro separators are circular gyratory screens used to separate solids from solids and liquid from solid. Vibro Sifter consists of Specially Designed Motor mounted vertically at the center of the base plate of the Screen. The Screen is in between feeding hopper and bowl. The material is fed on to the … Read more
Equipment must be located, designed, constructed, adapted, and maintained to suit the operations to be carried out. The layout and design of equipment must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt, and, in general, any adverse effect on the … Read more
GENERAL: SIFTING, MIXING ANG GRANULATION: COMPRESSION (TABLETS): COATING (TABLETS): FILLING OF HARD GELATIN CAPSULES: Empty Capsule shells shall be regarded as drug component and treated accordingly. They shall be stored under conditions which shall ensure their safety from the effects of excessive heat and moisture. PRINTING (TABLETS AND CAPSULES): PACKING OPERATION: Before packaging operations are … Read more
QUALIFICATION: Qualification is the planning, carrying out and recording of tests on equipment and systems, which form part of the validated process, to demonstrate that it will perform as intended. All manufacturing equipment, laboratory instrument and supporting utilities shall be considered for qualification. After successful completion of qualification exercise, the Equipment / instrument / Utilities … Read more
The premises used for warehousing, manufacturing, processing, storage, packaging labeling and testing purposes shall be; WAREHOUSING AREA: PRODUCTION AREA: ANCILLARY AREAS: QUALITY CONTROL AREA: REFERENCE: 1. Schedule M 2. 21 CFR art 210 & 211 3. WHO Technical Report Series 908
