Tag: LJUBLJANA

ANNUAL PRODUCT QUALITY REVIEW (APQR)/ PRODUCT QUALITY REVIEW (PQR)

Posted on By Pharmaceutical Guidanace

ANNUAL PRODUCT QUALITY REVIEW (APQR)/ PRODUCT QUALITY REVIEW (PQR) This Annual product Quality review should be conducted with the objective of verifying the repeatability of existing processes, the appropriateness of current specifications for raw materials and finished products, identifying any trends and identifying any improvements to products and processes. It helps establish preventive measures, and…

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Quality Assurance

Quality inspection (Self-inspections & Benefits of Self Inspection)

Posted on By Pharmaceutical Guidanace

Quality inspection (Self-inspections & Benefits of Self Inspection) Principle Importance and Benefits of Self Inspection What is needed Scope How can self-inspection be conducted Inspection Techniques Example of Self-Inspection Plan Who should be involved Self-inspection report Points to consider when performing self-inspection Stages of Self-Inspection Advantages & Disadvantages of Checklist Principle Self-inspections shall be conducted…

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Quality Assurance

PROCEDURE FOR QUALIFICATION/ REQUALIFICATION OF SYSTEM/ EQUIPMENT/ UTILITY/ INSTRUMENTS

Posted on By Pharmaceutical Guidanace

PROCEDURE FOR QUALIFICATION/ REQUALIFICATION OF SYSTEM/ EQUIPMENT/ UTILITY/ INSTRUMENTS PURPOSE :To describe the procedure for equipment / facility qualification: prepare qualification protocols, to initiate, conduct, and document equipment / facility qualification studies. SCOPE : This SOP shall be applicable to all new and upgraded process related equipment /facility. REFERENCE(S) :ISPE, Volume 5, Commission & Qualification. DEFINITION…

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Engineering

Autonomous Disinfection Solution

Posted on By Pharmaceutical Guidanace

Autonomous Disinfection Solution there is a new technological solution that has emerged in recent years to help combat the spread of disease in public spaces: autonomous disinfection robots. These robots are capable of cleaning and disinfecting public areas without human intervention, making them an ideal solution for high-traffic areas where cleanliness and hygiene are essential….

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Production

Pseudoephedrine & Mechanism of Action

Posted on By Pharmaceutical Guidanace

Pseudoephedrine & Mechanism of Action Pseudoephedrine temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies, and nasal congestion associated with sinusitis. Pseudoephedrine also temporarily relieves sinus congestion and pressure. Drug Class: Nasal Decongestant MECHANISM OF ACTION Pseudoephedrine is a sympathomimetic drug belonging to the phenethylamine and amphetamine chemical classes. Its principal mechanism of action depends on its effects…

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Production

Checklist for Do’s and Don’ts for Dissolution Analysis

Posted on By Pharmaceutical Guidanace

Checklist for Do’s and Don’ts for Dissolution Analysis Checklist for Do’s Always check the availability of chemicals and required glassware for the analysis. Before loading dissolution check the Calibration status of the instrument. Always check the water level of the dissolution bath (without a bowl). Check the clarity of the water bath. Check the status of…

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Quality Control

Checklist for Do’s and Don’ts for Using Glassware for Analysis

Posted on By Pharmaceutical Guidanace

Checklist for Do’s and Don’ts for Using Glassware for Analysis Checklist for Do’s Use Class A Glassware for analysis Use  transparent glassware for analysis Before using glassware for analysis check for cracks or breakage. Use exact capacity glassware by checking the marking of capacity e.g. ‘20’ flask not to be used for 25 ml capacity. Check…

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Quality Control

Checklist for Do’s and Don’ts for Sample preparation of temperature / light-sensitive material and product

Posted on By Pharmaceutical Guidanace

Checklist for Do’s and Don’ts for Sample preparation of temperature / light-sensitive material and product Checklist for Do’s In the case of temperature-sensitive / light-sensitive material collect samples from the respective storage area & allowed them to attain room temperature before using i.e weighing, pipetting, etc. During analysis close the sample container immediately after use and…

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Quality Control

DO’s & DON’Ts For Column care to avoid/Minimize incidences

Posted on By Pharmaceutical Guidanace

DO’s & DON’Ts For Column care to avoid/Minimize incidences 1.0 New HPLC Columns(Except Silica Columns for Normal Phase) DO’s Before using the new column wash the column with water followed by an appropriate solvent mixture. For Silica Column for washing use solvent as Given in the Column Certificate. DON’Ts Don’t saturate the new column directly…

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Quality Control

Checklist for Precautions during Sample Dilution /preparations in Wet Labs

Posted on By Pharmaceutical Guidanace

Checklist for Precautions during Sample Dilution /preparations in Wet Labs Checklist for Do’s Use a bulb pipette for further dilution. During pipetting Wipe off the tip with clean tissue paper. Adjust the meniscus to eye level by discarding the solution to waste. Transfer the amount to the volumetric flask. Touch the tip to the wall for…

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Quality Control

Hydrochlorothiazide and it mechanism of action

Posted on By Abha Maurya

Hydrochlorothiazide and its Mechanism of Action Hydrochlorothiazide is a thiazide diuretic used to treat edema associated with a number of conditions, and hypertension. Hydrochlorothiazide is the most commonly prescribed thiazide diuretic. The drug has been widely used to treat hypertension globally and is relatively very safe. Hydrochlorothiazide acts on the distal convoluted tubules and inhibits…

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Production

CEPHALOSPORINS & MECHANISM OF ACTION

Posted on By Abha Maurya

CEPHALOSPORINS & MECHANISM OF ACTION Cephalosporins are a group of semisynthetic antibiotics derived from ‘cephalosporin-C’ obtained from a fungus Cephalosporium. Cephalosporins are chemically related to penicillins the nucleus consists of a β-lactam ring fused to a dihydrothiazine ring, (7-aminocephalosporanic acid). By the addition of different side chains at position 7 of the β-lactam ring (altering…

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Uncategorized

OOS RECORDING PROCEDURE

Posted on By Abha Maurya

OOS RECORDING PROCEDURE REPORTING TO THE LABORATORY SUPERVISOR RECORDING AND NUMBERING OF OOS INVESTIGATION BY ANALYST LABORATORY TESTING APPROVAL BY LAB. SUPERVISOR TESTING BY ANALYST PROCEDURE OF OOS INVESTIGATION: A written record of the review should include the following information A clear statement of the reason for the investigation. A summary of the aspects of…

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Quality Assurance

SECONDARY WORKING STANDARDS

Posted on By Abha Maurya

REGULATORY RECOGNITION OF SECONDARY WORKING STANDARDS (1) Human Drug CGMP Notes, Vol 9, Number 3, 2001 (Internal FDA Publication): Q: Can a company use reference standards from sources other than the USP? A: Yes. Using a source other than USP can be acceptable provided the reference standard incorporates the critical characteristic properties, is suitable for…

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Quality Assurance

Temperature Mapping report template

Posted on By Abha Maurya

Temperature Mapping report template The mapping report should include the following sections: a. Introduction: a description of the objectives of the mapping study. b. Summary: a summary and discussion of the results organized in the sequence set out in the mapping protocol, including a summary of deviations (if any). c. Conclusions and recommendations: a general…

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Engineering

Electronic data logging monitor (EDLM)

Posted on By Abha Maurya

Electronic data logging monitor (EDLM): A small portable device that measures and stores temperature readings at predetermined time intervals by means of an electronic sensor. They have programmable alarm capabilities, and integrated displays, and can create reports and graphs which may be permanently stored, shared, and analyzed via proprietary hardware, software, desktop application, or hosted…

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Engineering

BET and sterility validation of microbiology 

Posted on By Pharmaguidanaces Channel

BET and sterility validation of microbiology  BET and sterility validation of microbiology consists of the following:- Protocol No. for BET and sterility validation should be written in format PR/MV/AA/ BB/CC/DD and report No. should be written in format RP/MV/AA/ CC/DD . PR refers to protocol, RP refers to Report, MV refers to microbiology validation. AA…

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Microbiology