Quality Cotrol
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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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Out of specification Investigation Step in pharmaceutical
Scope Input Martial In process stage Finish product Stability Note : Not applied in process stage which give procedure Further operation (e.g like give option in BMR if result not found as per Limit and further go operation e.g CF drying sample) Purpose: Ensure that...
Which is best solvent between Methanol vs Acetonitrile in HPLC
analytical method validation for pharmaceutical quality control
Type of analytical procedure validated Identification tests. Quantitative tests for impurities' content. Limit tests for the control of impurities. Quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in...
Theoretical Plates chromatography-analytical chemistry
Theoretical Plates chromatography In chromatography, theoretical plates are a fundamental concept used to assess the separation efficiency of a chromatographic column. They play a crucial role in determining the quality and effectiveness of the chromatographic...
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...
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HPLC Blogs
Which is best solvent between Methanol vs Acetonitrile in HPLC
Theoretical Plates chromatography-analytical chemistry
Theoretical Plates chromatography In chromatography, theoretical plates are a fundamental concept used to assess the separation efficiency of a chromatographic column. They play a crucial role in determining the quality and effectiveness of the chromatographic...
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...
More question
Analytical method validation Blog
analytical method validation for pharmaceutical quality control
Type of analytical procedure validated Identification tests. Quantitative tests for impurities' content. Limit tests for the control of impurities. Quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in...
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...
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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...