1 Get the facility design right from the start 2 Validate processes 3 Write good procedures and follow them 4 Identify who does what 5 Keep good records 6 Train and develop staff 7 Practice good hygiene 8 Maintain facilities and equipment 9 Build quality into the whole product lifecycle 10 Perform self audits
1. PW Generation, Storage and Distribution System2. WFI Generation, Storage and Distribution System3. PSG Generation and Distribution System
CFR – Code of Federal Regulations Title 21 [Code of Federal Regulations][Title 21, Volume 4][Revised as of April 1, 2013][CITE: 21CFR211] TITLE 21–FOOD AND DRUGSCHAPTER I–FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER C–DRUGS: GENERAL PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart J–Records and Reports Sec. 211.182 Equipment cleaning and use […]
Risk assessment is a systematic examination of a task, job or process that you carry out at work for the purpose of; Identifying the significant hazards that are present (a hazard is something that has the potential to cause someone harm or ill health). Now a day’s it’s a very popular approach in pharmaceutical industry, […]
There are different sizes and types of Air Handling Units. Some will fit in a closet or within a ceiling space, while others will require a mechanical room or will need to be placed on the roof of a building. Within all of them, however, there is at least one fan and one method of […]
Following qualification study to be perform during Installation qualification but not limited to · Training sheet (For keep the training attendance ) · Purchase order verification (To match with PO) · Drawing verification (To verify GA drawing, Electrical drawing etc.) · Document verification (To verify Installation manual, operation manual, test certificate etc) · Prestart review […]
Following activity shall be performing during the Installation qualification of but not limited to. General test o Availability of IQ test report verification o Standard operating procedure verification o General function test Automated control o Verification of Human Machine Interface o I/O status verification o Verification of Alarms & Interlocks o User Access test o […]
“Documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.” QUALIFICATION The premises, the supporting utilities, the equipment and the processes have been designed in accordance with the requirements of GMP. This normally constitutes Design Qualification or DQ. Design qualification […]
1. What is 21 CFR part ? Title 21 CFR Part of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) 2. Different between Qualification and Validation? “Qualification” refers to the activities performed on facility, utility and equipmentThe “Validation” refers to the activities performed on processes, practices and methods. 3. Critical […]
Step 1: Measure the length, width and height of the room using a good old fashioned tape measure 🙂 This will determine the size of the room or in other words its volume. Length x Width x Height = Step 2: Using a device called a ‘balometer’ measure the air supply coming out of the […]
