2018-12-17 03:02
*Disinfection*: Process by which surface bioburden is reduced to a safe level or eliminated.*Clean room*: A room designed, maintained and controlled to prevent particle and microbiological c… Read More
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answer of all pharma related question
2018-12-12 18:36
Every one in labs use glass pipettes for measurement but have you ever noticed different colour bands on the top of of pipettes (Blue, black, yellow, green, orange).We are going to tel… Read More
2018-11-26 17:10
*Disinfection*: Process by which surface bioburden is reduced to a safe level or eliminated.*Clean room*: A room designed, maintained and controlled to prevent particle and microbiological c… Read More
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
2017-07-27 02:06
What is Pharmacovigilance?Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse… Read More
2017-03-30 17:22
Following are the guidelines for stability study conduction for new products:1. Formal stability study should consist of accelerated and long term stability testing on at least two pri… 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
2017-01-27 16:56
Differentiation between an incidence and deviation when it occurs in pharmaceutical GMP manufacturing facility. It causes a big confusion to understand the occurrence of incidence… 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
2017-01-22 18:31
Dear Blogger and Followers,I had blogged titled: "Critical issue: Ready to use 90mm Petriplates of Himedia not as per Standard."I have withdrawn this blog because I had not do… Read More
2017-01-18 06:58
As per different guideline 90 mm petri plates are used for environmental monitoring and other microbial analysis, But Ready-made plates found less than 90 mmWhat is 90 mm petri plates?A… Read More
2016-11-21 18:03
What is Vent in Petriplates?Vented Petri dishes have a small lip on the top edge of the dish that allows the lid to sit a little up from the bottom, allowing for some air flow. Non-ven… 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
2016-10-09 01:30
Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of any document.Importance of documentation:As per GM… Read More
2016-09-24 02:13
The reason is behind the mode of action of 70% IPA. Bacterial cells have proteins in their cell wall and when this protein comes in contact with the 70% IPA during disinfectant application… 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 07:21
Q. Is the minimal approach accepted by regulators?Ans: Yes. The minimal approach as defined in Q8(R2) (sometime also called “baseline” or “traditional” approach) is t… 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
2016-06-24 16:56
Apparatus for Tests and AssaysChapter 21 Thermometers [This has been deleted]Biological Tests and AssaysChapter 162 Diphtheria Antitoxin Potency Testing for Human Immune Globulins [This is a… Read More
2016-06-23 17:06
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
2016-05-18 04:13
Introduce yourself Tell me about yourselfYour strength and weaknessWhy do you want to join us?How long will you stay with our company?.Your achievementsAre you planning for further stud… Read More
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 20:05
Data Integrity Means: - Accurate and reliable data and Information-Ensuring data trustworthiness and reliability-The degree to which a collection of data is complete… Read More
2016-05-04 03:32
The Acceptance Quality Level is a statistical tool to inspect a particular sample size for a given lot and set maximum number of acceptable defects. In order words, it is the worst tolerable… 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
2016-05-04 03:18
Know more about the Polyalphaolefin (PAO) used in HEPA filter integrity test during HVAC system qualification including their molecular structure. Poly Alpha Olefin (PAO) is used for HV… 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
2016-04-23 15:47
sodium salicylate is used as phosphor(light illuminating substance)to check the uv radiation and electrons so it is used an calibration for uv chamber Read More
2016-04-23 14:14
1. Assuming that you know everything2. Forgetting to network3. Not being prepared for meetings4. Ignoring the… Read More
2016-04-23 14:14
1. Assuming that you know everything2. Forgetting to network3. Not being prepared for meetings4. Ignoring the… 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
2016-04-11 14:32
The Spectral Bandwidth (SBW) of a spectrophotometer is thebasis of establishing its ability to resolve absorbtionlines seperated by small differences in wavelength. If asubstance that you ne… Read More
2016-04-08 05:43
Cleanroom Guideline Revised Version-ISO 14644-1:2015-12New version includes the following changes:1. The number of measuring points is no longer calculated as the square root of the su… Read More
2016-04-07 03:22
Autoclavable Munising PaperWe all know ,that in documentation is very important in pharma industry we use A4 size paper for documentation"Paper should is main source o… Read More
2016-04-05 17:43
The sampling formula SQRT n+1 in pharmaceuticals and its recommendations in various guidelines.Quality of pharmaceutical products majorly depends upon the sampling of the excipients and the… 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
2016-04-02 17:57
Purity means other than impurity or absence of impurity & we are calculating by area normalization.while Potency is content of that substances in the sample and calculatin… 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 13:24
वर्क-लाइफ में हमें तरह तरह के लोग… 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
2016-03-26 12:45
AWC work on the principal of Compression force. In this first we set the machine on lower fill weight against the standard limit of the product and observe the avg. compression force. Simila… Read More
2016-03-25 17:39
Water purification is a necessary process for the water used in pharmaceutical manufacturing because it contains a lot of suspended material as well as in the form of ions. Turbidity an… 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
2016-03-20 02:02
In the pharmaceutical industry and bioscience research field, many laboratories make use of analytical balances. The analytical balances used in the bioscience research and pharmac… Read More
2016-03-19 18:56
1. Wear personal protective equipment one common GMP mistake is not wearing your safety glasses. Your eyes are too precious not to protect them. Always wear your safety glasses, safety shoes… Read More
2016-03-17 22:34
दुनिया में सबको एक अच्छी और सिक्… Read More
2016-03-16 18:46
1. WHO Guidelines2.ICH Guidelines 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
2016-03-16 08:56
In pharmaceuticals alert and action limits are very important. These limits are used to have effective control over the process. Alert Limits: Alert limits are in house limits which are def… Read More
2016-03-16 08:37
KF standardisation with water:Formula = wt of warter*1000/KF titer value Read More
2016-03-15 04:49
In pharmaceutical companies monitoring of controlled area is performed by two methods. 1 Viable particle monitoring 2 Non- viable particle monitoringIn pharmaceutical companies drugs are ma… Read More
2016-03-15 04:03
During AHU validation, following tests shall be carried out· Filter efficiency test,· Air velocity & number of air changes,· Air flow pattern (visualization)·… Read More
2016-03-15 03:40
The volume of mobile phase required to elute an un retained compound from column which is equal to column volume.It is very much less possibility if the any impurity elutes before dead volum… Read More
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