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FDA and USFDA focus in OOS investigation
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Guideline
QMS(Quality Management)
ALCOA to ALCOA Plus for Data Integrity
The term Alcoa is an Acronym, which stands for Attributable, Legible, Contemporaneous, Original and Accurate. Alcoa was then expanded to Alcoa
Plus (Alcoa +), by the addition of a few more concepts which are; Complete, Consistent, Enduring and Available.
Over time, the concept of Alcoa plus has been adopted by various industries, as a framework for ensuring that data
OOS Handle
The objective of OOS investigation should be to identify the root cause of the OOS result Or NSQ results and take appropriate corrective and preventative action. Investigation should include a review of Laboratory testing, review of production and sampling procedures, and will often include additional laboratory testing and Cross functional investigation along with the handling of associated samples and test data
Change Controle
The term change control is used to describe the controlled set of actions necessary to ensure a change does not negatively impact a product’s safety, efficacy, quality or compliance.
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Type of HPLC column
In HPLC chromatography, the column is where the separation of the sample takes place. This is where the sample is passed through the stationary phase with the mobile phase, resulting in the separation of the sample components. As the sample being analyzed is likely to...
621 no chapter chromatography was update at on date 1-dec-2022
What is update change Definitions Here Definitions and chromatograms both unified and give title Definitions Give method dwell volume determine being added Definitions add definitions size-exclusion chromatography (Distribution constant, Retention time of an...
Latest pharmacopoeia
USP 44-NF 39, which became official on November 1, 2021.
Type of Compartment of HPLC & GC ?
HPLC Going into more detail, HPLC consists of a variety of components, including a solvent delivery pump, a degassing unit, a sample injector, a column oven, a detector, and a data processor. GC GC uses an inert or unreactive carrier gas as the mobile phase, and the...
How to Re-test defined in finish product in pharma
In the pharmaceutical industry, a "finished product retest" refers to the process of evaluating a sample from a previously manufactured and packaged pharmaceutical product to assess its quality, safety, and efficacy. The purpose of the retest is to ensure that the...
Type of stability and its effect drug product in pharma industry
Chemical: Each API (active ingredient retains its chemical integrity and labeled potency within the specified limit. Physical: the physical stability properties includes appearance, palatability, uniformity, dissolution and suspend ability are retained....
Type of buffer in Hplc
Phosphate buffer Citrate buffer Formate buffer Acetate buffer Tris(hydrixymethyl) -aminomethane Phosphate buffer Pka 2.1 Ph range 1.1 tob3. 1 Pka 7.2 Ph range 6.2 to 8.3 Pk 12.3 Ph range 11.3 to 13.3 Citrate Pka 3.1 Ph range 2.1 to 4.1 Pka 4.7 Ph 3.7 to 5.7 Pka 5.4 Ph...
OOS- Out of Specification Investigation – Interview Question and Answer
Do we need to raise an OOS, if OOS result is observed during API Method transfer First defined which lab mean by At receiving lab At originating lab YES Required Caution: inform API vendor about failure Investigation release analysis Assess impact on DP(drug product)...
Umedica Laboratories Ahmedabad interview 23rd April 2023 for Production Department Quality Control Quality assurance Packing Department etc check now
JUMEDICA LABORATORIES PVT. LTD. UMEDICA is a manufacturer and exporter of Pharmaceutical Formulations viz; Injectable, Tablets, Capsules, Suspensions, Dry Syrups, etc. Since our inception in 1982, we have established ourselves as a company delivering products meeting...
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HPLC Blogs
Type of HPLC column
In HPLC chromatography, the column is where the separation of the sample takes place. This is where the sample is passed through the stationary phase with the mobile phase, resulting in the separation of the sample components. As the sample being analyzed is likely to...
621 no chapter chromatography was update at on date 1-dec-2022
What is update change Definitions Here Definitions and chromatograms both unified and give title Definitions Give method dwell volume determine being added Definitions add definitions size-exclusion chromatography (Distribution constant, Retention time of an...
Latest pharmacopoeia
USP 44-NF 39, which became official on November 1, 2021.
Type of Compartment of HPLC & GC ?
HPLC Going into more detail, HPLC consists of a variety of components, including a solvent delivery pump, a degassing unit, a sample injector, a column oven, a detector, and a data processor. GC GC uses an inert or unreactive carrier gas as the mobile phase, and the...
Type of buffer in Hplc
Phosphate buffer Citrate buffer Formate buffer Acetate buffer Tris(hydrixymethyl) -aminomethane Phosphate buffer Pka 2.1 Ph range 1.1 tob3. 1 Pka 7.2 Ph range 6.2 to 8.3 Pk 12.3 Ph range 11.3 to 13.3 Citrate Pka 3.1 Ph range 2.1 to 4.1 Pka 4.7 Ph 3.7 to 5.7 Pka 5.4 Ph...
HPLC Calibration As per IPC Pharmacopeia give guidance
HPLC Calibration we have perform as earlier as per protocol Company will provided Like example Shimanzu HPLC calibration will perform as per that guidance's But now a day In 16th September 2021 As per IPC Pharmacopeia give guidance(Document ID IPC/GD/05) HPLC...
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Analytical method validation Blog
Type of HPLC column
In HPLC chromatography, the column is where the separation of the sample takes place. This is where the sample is passed through the stationary phase with the mobile phase, resulting in the separation of the sample components. As the sample being analyzed is likely to...
Specificity in analytical method validation – type of interference
Specificity As per ICH Q2A guideline defined as Specificity is the ability to assess unequivocally analyte in the present of component which may expected to present. Typically these might include impuries, degradants, matrix etc Selectivity The extent to which the...
Different between method validation ICH & ANVISA
FORCED DEGRADATION: ICH: a2R1) VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY ANVISA: CoLLEGIATE BOARD RESOLUTION - RDC No. 53, OF DECEMBER 4, 2015 Topic: metal ion catalysed oxidation ICHNOT required ANVISARequired analysis cu 2+, Fe 3+(accelerate,...
How can read Protocol analyst
HPLC Analyst ○ Whenever supervisor give work allocation for testing any product. ○ HPLC analyst first seen Test which is Assay by HPLC or RS By HPLC, Chiral test etc ○ Then careful read specification(SOP) not missing any point which is defied in sop ○ Then Seen Which...
Chromatography
Chromatography
Analytical method validation (before requirements)
• the requirements of the measurement procedure• scope of experiments• RM to be used• Equipment• Statistical tools to be used• personnel for performing experiments and evaluating obtainedresults Analytical method validation
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During Job How to Control your self Blogs
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Fighting Interview Fear – Why candidates get nervous during an interview ?
Interview fear is nothing to be ashamed of. In fact, it’s natural, stemming from the human desire to seek approval and validation. So, first, when trying to deal with your interview fear, it’s important to recognize that interview fear is normal—and have some...
Thought of the day 2023
“Keep relations, which change your situations, not ones which itself gets changed according to situations.” No one is too much busy. It’s all about importance you have in their life.” “Negative perception and wrong judgement astray a man in...