Building Management System (BMS) is monitor and control the parameters of HVAC system like temperature, relative humidity and air quantity to maintain a controlled environment.
read moreHow are Disinfection Qualification Studies Regulated? The success of disinfection procedures used in an aseptic manufacturing environment and the qualification of such processes to complying with GMP’s are not detailed in a simple guidance document. Although there is no harmonized protocol addressing…
read moreClean room practice is one of the toughest task in sterile pharmaceuticals. Now a days advanced HVAC system was designed to provide human comfort at working area and to maintain clean room requirement as per guidelines. Major regulatory guidelines now a days available…
read more1. PW Generation, Storage and Distribution System2. WFI Generation, Storage and Distribution System3. PSG Generation and Distribution System
read moreCFR – 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…
read moreThere 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…
read moreFollowing 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…
read moreFollowing 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…
read more“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…
read moreStep 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…
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