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2018-02-27 02:55
Fumigation and fogging are very important processes in cleanroom area to minimize andcontrol the microbial load.To keep the controlled area from beingcontaminated in pharmaceuticals, twoproc… Read More
2017-03-30 17:21
1. How the pH of mobile phase changes?The pH of a mobile phase pH can change if u keep it for long hours due to the effect of CO2 from the atmosphere to affect pH.Similarly, volatile reagent… Read More
2017-01-23 17:41
Q. What are the factors which influence tablet hardness?Ans: 1.compression force        2.Binder quantity(More binder more hardness)     &nb&hell…Read More
2017-01-23 17:29
Q: What are the requirements of 21 CFR 11?A: 21 CFR 11 requires that closed computer systems must have a collection of technological and procedural controls to protect data within the system… Read More
2017-01-23 17:24
Flame Photometric Detector or GC-FPD is a technique used to analyse sulphur or phosphorous containing compounds and metals such as tin, boron, arsenic and chromium. An FPD uses a Hydrogen/Ai… Read More
2017-01-23 16:53
HPLC is useful for analysis of samples which are liable to decompose at higher temperatures. GC involves high temperatures so compounds are stable at such temperatures.In HPLC the mobil… Read More
2016-11-17 05:06
☄Failure ☄Mode and ☄Effects Analysis (FMEA) and Failure Modes, Effects and ☄Criticality ☄Analysis (FMECA) are methodologies designed to identify potential failu… Read More
2016-09-24 02:11
Along with data integrity, deficiencies in sterility assurance and the potential for product or API contamination identified during FDA inspections often lead to warning letters. Also many p… Read More
2016-09-11 02:42
There are different forms those are issued by the FDA at the different stages of the regulatory audits. Different issues are communicated through these forms between FDA and the manufacturin… Read More
2016-08-28 03:45
1. Always record the entries at the time of activity simultaneously.2. Always record date with signature in GMP records.3. Always use indelible ballpoint pen to record data in GMP records.4… Read More
2016-07-25 17:05
1. What is Safety ?It is a condition which gives you freedom from hazard, risk, accident which may cause injury, damage and loss to material or property damage and even death.    … Read More
2016-07-09 07:27
Q :What are Interventions in Aseptic manufacturing? and its various types…InterventionAseptic manufacturing has shown some brilliant improvements scientifically and technically over t… Read More
2016-07-09 07:25
Corrective and preventive action (CAPA, also called corrective action / preventive action, or simply corrective action) are improvements to an organization's processes taken to eliminate cau… Read More
2016-07-09 07:22
WHO publishes Draft of an Umbrella Guideline on Process ValidationAt the end of 2015, the WHO adapted its Appendix 7 to the latest technological standards. Appendix 7 provides support with r… Read More
2016-07-09 07:12
Validation is a process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of complian… Read More
2016-07-01 02:04
Q: What are the requirements of 21 CFR 11?A: 21 CFR 11 requires that closed computer systems must have a collection of technological and procedural controls to protect data within the system… Read More
2016-07-01 01:58
An air handler, or air handling unit (often abbreviated to AHU), is a device used to condition and circulate air as part of a heating, ventilating, and air-conditioning (HVAC) system. An air… Read More
2016-06-23 01:51
A cheque is a payment instrument that is issued by a bank account holder for making payments to an individual or company and cash withdrawals from the bank. Apart from that, it als… Read More
2016-06-18 05:55
The purpose of the Growth Promotion Test is to determine the suitability of culture media. The medium is challenged with a small number of microorganisms to assure the nutritive properties… Read More
2016-06-01 17:44
Sterilization process in pharmaceutical industry in an autoclave will be considered qualified for consistent and reliable performance (validated) on successful completion of the following te… Read More
2016-05-18 06:46
Know different climatic zones by ICH in the world for stability conditions including Temperate, Mediterranean / subtropical, Hot dry, Hot humid / tropical and hot & higher humidity zones… Read More
Quality Assurance Interview Question
2016-05-18 04:12
Define quality assuranceDifference Between Quality assurance and Quality controlWhat is cGMP?Difference between cGMP and GMPICH GuidelinesDifference between validation and calibrationWhat is… Read More
2016-05-14 01:04
Following is the list of guidelines:Q1A(R2) - Stability Testing of New Drug Substances and ProductsQ1B - Stability Testing: Photostability Testing of New Drug Substances and Produc… Read More
2016-05-04 20:12
The notice period is the time period between the receipt of the letter of dismissal and the end of the last working day. This time period has to be given to anemployee&nb&hell…Read More
2016-05-04 03:26
🏻ICH Guidelines : International council on harmonisation guidelines.🏻WHO Guidelines : World health organization guidelines.🏻IPEC Guidelines: The international pharmac… Read More
2016-04-23 15:57
IntroductionRapid microbiology methods have long been essential tools of the clinical and food industry microbiology laboratories. Swift diagnosis of infectious diseases by clinical labs and… Read More
2016-04-15 17:31
AADA: Abbreviated antibiotic drug applicationADE: Adverse drug eventADME: Absorption, distribution, metabolism, and excretionAHU: Air Handling UnitANDA: Abbreviated new drug applicationANVIS… Read More
2016-04-03 09:24
1. Testing of Steam for Porous Product SterilizationBefore commencing temperature testing the correct conditions must be satisfied. The first condition for sterilization of porous product is… Read More
2016-03-31 03:04
 What is validation?GMP-definition is the validation of "establishing documented evidence that establishes a high degree of certainty that a particular process will consistent… Read More
2016-03-31 03:04
 What is validation?GMP-definition is the validation of "establishing documented evidence that establishes a high degree of certainty that a particular process will consistent… Read More
2016-03-28 01:55
1 Can any deviation be changed into the change control?2 What is the difference between Humidity and Relative Humidity?3 What should be the temperature and humidity for the tablet compr… Read More
2016-03-28 01:55
1 Can any deviation be changed into the change control?2 What is the difference between Humidity and Relative Humidity?3 What should be the temperature and humidity for the tablet compr… Read More
2016-03-22 12:38
Resigning from a job is something that most of us will have to face at some point in our careers – and there’s a right way and a wrong way to do it. If you’re thinking abou… Read More
2016-03-21 16:49
Job Interview TipsHere are a few more do's and don'ts for being at your best during a job interviewJob Interview Do's:Preparing for a job interview is essential to making a good impression… Read More
2016-03-21 01:57
1. OOS (out of specification) is the comparison of one result versus a predetermined specification criteria while OOT (Out of Trend) is the comparison of many historical… Read More
2016-03-21 01:57
1. OOS (out of specification) is the comparison of one result versus a predetermined specification criteria while OOT (Out of Trend) is the comparison of many historical… Read More
2016-03-16 12:19
Different tests done during the validation of vial washing machineSterile pharmaceutical preparations as injections are filled in glass vials. These vials should be cleaned properly before f… Read More
2016-03-16 09:18
Root cause analysis is done to determine the main cause of the error or problem caused during the process. Root cause for the out of specification, deviations during manufactu… Read More

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