How 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 the regulatory requirements associated with disinfection qualification studies, there are several approaches, principles […]
Safety is our main aim. Don’t think life is a game. Be alert open your mind- Don’t be fool and act as blind. Use proper tool by keep your mind cool, Never being hurry and never being worry, Prepare & prevent instead of repair & repent. Remember!! Accident Big or Small- Let them avoid all. […]
Clean 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 with well define limits of viable and non viable for different grades (A,B,C,D). But […]
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 […]
