RECEIVING OF RAW MATERIALS FROM THE DISPENSING AREA TO THE PRODUCTION DAY STORE AREA
RECEIVING OF RAW MATERIALS FROM THE DISPENSING AREA TO THE PRODUCTION DAY STORE AREA
GOOD LABORATORY PRACTICE
GOOD LABORATORY PRACTICE Good Laboratory Practices (GLP) is a quality system concerned with organizational process and conditions under which non-clinical health and environment safety studies are planned, performed, monitored recorded, archived, and reported.
CLEANING OF CONTAINERS USED TO HOLD PROCESS MATERIAL
CLEANING OF CONTAINERS USED TO HOLD PROCESS MATERIAL
Introduction of New Product in Facility
Introduction of New Product in Facility The implementation of a novel product in a pharmaceutical industries necessitates a Carefully planned & organized sequence of actions to guarantee a seamless and adheres to regulations and guidelines. Below is an exhaustive compilation of activities that should be taken into account: New Product Project Planning: Create a project plan…
Emulsion & Role of Emulsifying Agents
Emulsion & Role of Emulsifying Agents Emulsion refers to a colloidal dispersion where two liquids that do not mix are blended uniformly. It comprises small droplets of one liquid dispersed in another liquid. The stability of emulsions is of utmost importance in various industries such as food, pharmaceuticals, and cosmetics. Emulsifying agents are commonly employed…
Premises & HVAC system design
Premises & HVAC system design Both the architectural design of the building and the HVAC system design should be carefully considered to achieve the objectives of preventing contamination and cross-contamination and ensuring a suitable environment for pharmaceutical production and control. It is crucial to maintain the required environmental conditions, cleanliness, and containment. Infiltration of outside…
CLEANING AND OPERATION OF MULTI MILL
CLEANING AND OPERATION OF MULTI MILL Multi mill operates on the principle of variable force swing beaters having both knife and impact edges rotating within a selected screen to get the required size reduction. In multi mill particle size reduction is done through impact in air, on material by blades moving at high speeds, inside a cylindrical hopper.
CLEANING AND OPERATION OF OSCILLATING GRANULATOR
CLEANING AND OPERATION OF OSCILLATING GRANULATOR OSCILLATING GRANULATOR is Solids size-reducer in which particles are broken by oscillating stirrer arranged over a screen of suitable mesh.
CLEANING AND OPERATION OF FLUID BED DRYER
CLEANING AND OPERATION OF FLUID BED DRYER FLUID BED DRYER is used in the granulation process for drying the material to get desired moisture content. If the air is allowed to flow through a bed of solid powdered material in the upward direction with the velocity greater than the settling rate of the particles, the…
FDA – Warning Letter – October 20, 2023
Warning Letter – October 20, 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, from February 20 to March 2, 2023. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210…
Clean Room Quiz 6
Clean Room Quiz 6 Question: What is the purpose of an airflow direction test and visualization? Answer: The purpose of an airflow direction test and visualization is to demonstrate that the airflow direction and its uniformity of velocity conform to the design and performance specifications. Question: What are the four methods used for performing the…
Clean Room Quiz 5
Clean Room Quiz 5 Question: What is recommended for measuring the supply air volume flow rate in cases where there is local airflow turbulence and jet velocities issuing from an outlet? Answer: It is recommended to use an airflow capture hood that captures all of the air issuing from each final filter or supply diffuser….
Clean Room Quiz 4
Clean Room Quiz 4 Question: What is the purpose of the airflow test? Answer: The purpose of the airflow test is to measure airflow velocity, uniformity, and supply air volume flow rate in cleanrooms and clean zones. This includes measuring velocity distribution in unidirectional airflow areas and supply air volume flow rate in non-unidirectional areas….
Clean Room Quiz 3
Clean Room Quiz 3 Question: When need to plan for testing and verification testing should be conducted according to the ISO 14644? Answer: Testing should be carried out at minimum during the following instances: a) In connection with classification according to ISO 14644-1; b) At verification during start-up; c) At verification after failures have been…
Clean Room Quiz 2
Clean Room Quiz 2 Question: What is the objective of the air pressure difference test.? Answer: The objective of the air pressure difference test is to confirm the effectiveness of the cleanroom’s air movement system in maintaining the designated pressure differential between the cleanroom and its surrounding environment. Question: When should the air pressure difference…
Clean Room Quiz 1
Clean Room Quiz 1 -Question & answers on Clean Room Question: What is the definition of an “airborne particle”? Answer: An airborne particle is described as a solid or liquid object suspended in the air, whether viable or non-viable, falling within a size range spanning from 1 nanometer (nm) to 100 micrometers (μm). Question: How…
Deepawali 2023
Deepawali The five-day Diwali, starting November 10, includes Dhanteras, Choti Diwali, Diwali, Govardhan Puja, and Bhai Dooj. Here’s everything you need to know. Diwali, also known as Deepavali, the biggest Hindu festival, is just around the corner and people are already busy with preparations. It falls on the 15th day of the month of Kartik,…
SOP FOR HANDLING AND STORAGE OF DIES & PUNCHES
SOP FOR HANDLING AND STORAGE OF DIES & PUNCHES
Pre-dispatch inspection
What is Pre-dispatch inspection? Pre-dispatch inspection is a step taken by manufacturers to inspect finished products before dispatch of the finished product for sale and distribution in the market for the supply of medicine to user points. The purpose of Pre-dispatch inspection is: Check the quantity and quality of the finished product. Check the product…
Alarm management & Alarm Challenge Test
Alarm management Alarm management is the understanding, design, implementation, and use of effective alarm capabilities for plant operators. It is designed to notify the operator of situations or events that require the operator’s attention. Explicitly within a reasonable time frame. Designer of production process control systems. These systems are traditionally configured. Equipment for measuring the…