Tag Archives: Antrim and Newtownabbey

Checklist for Precautions during Sample Dilution /preparations in Wet Labs

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 …

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Hydrochlorothiazide and it mechanism of action

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 …

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CEPHALOSPORINS & MECHANISM OF ACTION

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 …

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SOP On SOP – Initiation of new SOP In Pharma Industry

SOP On SOP – Initiation of new SOP In Pharma Industry The fundamental purpose of an SOP in pharma is to provide clear and concise instructions for the consistent execution of routine operations within an organization. By offering a step-by-step guide on how tasks should be carried out, SOPs aim …

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REGULATORY IMPACT ON OOS

REGULATORY IMPACT ON OOS Stability study required OOS should be reported to RA OOS batch should not be sold to the Regulatory market OOS batch can not be blended with a fresh approved batch OOS batch can not be directly sold to the market Reporting Test Result Result: Averaging Appropriate …

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OOS RECORDING PROCEDURE

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 …

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SECONDARY WORKING STANDARDS

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 …

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Temperature mapping protocol

Temperature mapping protocol A well-designed protocol will help ensure that the mapping study is correctly carried out. To cover the full range of temperature regimes, a standard protocol can be used to map any storage area in the facility The mapping protocol should contain the following sections: a. Approval page …

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Temperature Mapping report template

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. …

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Electronic data logging monitor (EDLM)

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, …

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BET and sterility validation of microbiology 

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 …

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Process validation protocol

Process validation protocol A written plan stating how validation will be conducted, including test parameters, product characteristics, production and packaging equipment, and decision points on what constitutes acceptable test results. The process validation protocol is defined as the experimental plan that design thoroughly the validation programmed. Protocol of the Process …

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GMP Inspection HPLC Checklist 

GMP Inspection HPLC Checklist HPLC is an abbreviation for High-Performance Liquid Chromatography. “Chromatography” is a technique for separation, “chromatogram” is the result of chromatography, and “chromatograph” is the instrument used to conduct chromatography. HPLC dedicated to molecular separation called columns and high-performance pumps for delivering solvent at a stable flow rate …

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Audit checklist for Purified Water System

Audit checklist for Purified Water System Purified water is water that has been mechanically filtered or processed to remove impurities like bacteria, viruses, chemical pollutants, and minerals like lead and copper, Purified Water is intended for use as an ingredient of official preparations and in tests and assays unless otherwise …

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Good Manufacturing Practices (GMPs)

Good Manufacturing Practices (GMPs) CGMPs provide systems that assure proper design, monitoring, and control of manufacturing processes and facilities.  Good Manufacturing Practices (GMPs) are the basic manufacturing and environmental conditions required to produce pharmaceutical products. They ensure that ingredients, products, and packaging materials are handled safely and that pharmaceutical products …

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Liquid pharmaceutical Preparations

Liquid pharmaceutical Preparations A solution is a homogenous one-phase system consisting of two or more components. →solvent + solute • The solvent is that phase in which the dispersion occurs and the solute is that component that is dispersed as small molecules or ions in the solvent. • Liquid preparations: …

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PARENTERAL PREPARATIONS

PARENTERAL PREPARATIONS Parenteral preparations are sterile preparations intended for administration by injection, infusion, or implantation into the human or animal body. Parenteral preparations may require the use of excipients, for example, to make the preparation isotonic with respect to blood, to adjust the pH, to increase solubility, to prevent deterioration …

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Most common types of pharmaceutical contamination

Most common types of pharmaceutical contamination Contamination can lead to objectionable results in the Pharma industry. It can conciliate the safety of patients, staff, and the environment – as well as affect the market. High standards of hygiene are important to maintain, only preventing the bio-burden levels by means of …

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HVAC SYSTEM AND TEST FOR HVAC QUALIFICATION

HVAC

HVAC SYSTEM AND TEST FOR HVAC QUALIFICATION What is HVAC? HVAC controls Temperature, Humidity, and Air quality inside a building. HVAC technology aims to provide thermal comfort and acceptable indoor air quality. HVAC system design is a sub-discipline of mechanical engineering, based on the principles of thermodynamics, fluid mechanics, and heat …

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Change Management in Pharma

Change Management In Pharma Change Management in Pharma is a formal process for making planned and unplanned changes to the existing approved procedure and policy. The primary objective of Change Management in Pharma is to provide standardized methods and procedures to meet the change management requirements supporting operations. Change control …

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