The dissolution specification is defined by the amount (Q) of active substance that dissolves within a designated time frame, represented as a percentage of the content indicated on the product label. According to the Indian Pharmacopoeia, the dissolution specification is articulated in terms of the amount (D) of active substance that dissolves in a specified … Read more
Formulation of the coating solution: Adequate preparation of the coating solution is essential for achieving an effective coating within a reasonable timeframe. This solution is prepared in S S vessels equipped with a stirrer. Various techniques are beneficial in facilitating the prompt formulation of coating solutions: Dispersion in hot water: The coating materials remain insoluble … Read more
Water is commodiously used as a raw material, ingredient, and solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients (APIs) and intermediates, and analytical reagents. Types of Water: Raw Water: Raw water is a natural water available in the environment, such as rainwater, ground water, and water from bodies like lakes … Read more
Packaging is defined as the collection of different components which surround the pharmaceutical product from the time of production until its use. Importance of packaging: It is important to produce a pharmaceutical product with high quality standards and even it is more important to protect that product form the degradation, external contamination and other physical/chemical … Read more
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
The analysis will be carried out in the lab and after analysis if the received material is appropriate (complying with all the specific limits) Material will be released by the QC which means it can be used for the Packing of the Material. For Primary Material: For Secondary & Tertiary Material: Different type of testing … 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
