Design BMS (Building Management System) in Pharmaceuticals Industries
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.
Tag: USCGMP
Selection of Glass Vial Sterile Injectable product
Selection of Glass compatibility with drug product is major issue in Sterile Pharmaceutical practice. Physical and & Chemical stability is the major issue. Wrong selection of glass type caused breakages during Lyophilization, washing, DHS etc activity. “ As per 21CFR211.94 Drug product containers and closures: (a) Drug product containers and closures shall not be reactive, […]
Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 6)
Few basic question ask during interview of fresher candidates (B.pharma /M.pharma) in HR round, so get ready and be prepared for interview 1. What is your aim in life? 2. Who has inspired you in your life and why? 3. Why you have chosen Pharmaceutical Education? 4. What is your hobby? 5. Give me an […]
Qualifying Disinfection for Critical Environments and Cleanrooms
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 1st priority
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. […]
Start Clean Room Qualification
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 […]
THE TEN GOLDEN RULES OF GMP
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
Water System Design In Pharmaceutical Industry In Sterile Injectable Facility
1. PW Generation, Storage and Distribution System2. WFI Generation, Storage and Distribution System3. PSG Generation and Distribution System
Equipment cleaning and use log as per regulatory requirment
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 […]
A to Z Risk Management with statistical approach
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, […]