Risk assessment consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards as defined below. Quality risk assessments begin with a well-defined problem description or risk question. When the risk in question is well defined, an appropriate risk management tool and the types of information needed … 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
This guidance provides recommendations to sponsors of new drug applications (NDA’s), abbreviated new drug applications (ANDA’s), and abbreviated antibiotic applications (AADA’s) who intend, during the post approval period, to change: SU: Scale-up during original dossier assessment. Note that this is not SU during development. Consider changes made after the Biobatch PAC: Post-PQ/post-approval, i.e. Variations. … 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
TABLET COMPRESSION: Reducing the bulk volume of a powder by applying mechanical force so as to form a defined shape of desired weight and strength is called ‘Compression’. Tablet compression is the process of squeezing powders together and driving out the air between the particles, resulting in a compressed Tablet. WHY COMPRESSION? TABLET PRESS OR … Read more
BLENDING PROCESS: Blending of solid particles refers to mixing of solids with the aim of attaining a uniform composition throughout the mix. In powder blending two or more dissimilar particulate solids are blended to give a random mix. Objective of blending is to form a homogeneous final product from two or more dissimilar raw materials. … Read more
MILLING PROCESS: Milling process is also called as ‘screening’ and ‘sizing’ process. Milling is employed between RMG and Blending to crush the larger particles from granulation into uniform small particles which meets the process requirement. Milling isperformed to remove lumps, improve flow, reduce segregation and to control the particle size. Milling is performed by using … Read more
