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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 beĀ 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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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 Ā (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, includingĀ 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 propertiesĀ 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...
How to investigation and take CAPA ? Deviation, Lab incident, OOS
Why investigation? To identified error Ā Random error Impacts precisionĀ (Weight error dilutionĀ Ā error injection to injection error Example document error, document error [Ā note :Ā Precision show random error which is not control for us] +- positive and negative error...
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HPLC Blogs
Type of Compartment of HPLC & GC ?
HPLC Going into more detail, HPLC consists of a variety of components, includingĀ 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 exampleĀ 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...
How can read Protocol analyst
HPLC Analyst ā Whenever supervisor give work allocation for testing any product. ā HPLC analyst first seen Test which is Assay by HPLC or RS By HPLC, Chiral test etc ā Then careful read specification(SOP) not missing any point which is defied in sop ā Then Seen Which...
How can read Protocol analyst During HPLC analysis and what Is flow ?
ā¢ HPLC Analyst ā Whenever supervisor give work allocation for testing any product. ā HPLC analyst first seen Test which is Assay by HPLC or RS By HPLC, Chiral test etc ā Then careful read specification(SOP) not missing any point which is defied in sop ā Then Seen...
Chromatography
Chromatography
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Analytical method validation Blog
Specificity in analytical method validation – type of interference
Specificity As per ICH Q2A guideline defined as Specificity is the ability to assessĀ 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 ā Whenever supervisor give work allocation for testing any product. ā HPLC analyst first seen Test which is Assay by HPLC or RS By HPLC, Chiral test etc ā Then careful read specification(SOP) not missing any point which is defied in sop ā Then Seen Which...
Chromatography
Chromatography
Analytical method validation (before requirements)
ā¢ the requirements of the measurement procedureā¢ scope of experimentsā¢ RM to be usedā¢ Equipmentā¢ Statistical tools to be usedā¢ personnel for performing experiments and evaluating obtainedresults Analytical method validation
Why does Acetonitrile use in HPLC Method development?
it is miscible with water, has good eluotropic strength and also low viscosity alone and mixed with water. Acetonitrile high-sensitivity analysis with UV detection in the short-wavelength region. However , organic solvents which have been processed for HPLC IN...
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During Job How to Control your selfĀ Blogs
Fighting Interview Fear – Why candidates get nervous during an interview ?
Interview fear is nothing to be ashamed of. In fact, itās natural, stemming from the human desire to seek approval and validation. So, first, when trying to deal with your interview fear, itās important to recognize that interview fear is normalāand have some...
Thought of the day 2023
āKeep relations, which change your situations, not ones which itself gets changed according to situations.ā No one is too much busy. Itās all about importance you have in their life.āĀ āNegative perceptionĀ and wrong judgement astray a man in...
Feeling in winter
Symptoms Feeling listless, sad or down most of the day, nearly every day Losing interest in activities you once enjoyed Having low energy and feeling sluggish Having problems with sleeping too much Experiencing carbohydrate cravings, overeating and weight gain Having...