Tag Archives: Treviso

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 …

Read More »

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 …

Read More »

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 …

Read More »

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 …

Read More »

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 …

Read More »

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 …

Read More »

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 …

Read More »

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. …

Read More »

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, …

Read More »

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 …

Read More »

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 …

Read More »

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 …

Read More »

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 …

Read More »

HPLC Chromatography

HPLC Chromatography (Questions & Answers) HPLC is a chromatographic technique that employs a liquid mobile phase to separate and analyze components of a sample. Unlike traditional liquid chromatography, HPLC utilizes high pressure to force the liquid mobile phase through a packed column, enhancing separation efficiency and speeding up analysis times. …

Read More »

Design Qualification of Gelatin Colour Mixer

Design Qualification of Gelatin Colour Mixer OBJECTIVE: To design, engineer and supply the Gelatin Colour Mixer and to provide assurance that the machine is manufactured and it complies with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in …

Read More »

SOP for operation of Strip Packing Machine

A -

SOP for operation of Strip Packing Machine Standard Operating Procedure (SOP) Objective To lay down a procedure for operation of Strip Packing Machine. Scope This SOP is applicable for the operation of Strip Packing Machine used to pack the Tablets and Capsules into Strips in the formulation plant. Responsibility Production …

Read More »

Installation Qualification of Gelatin Storage Vessel

Installation Qualification of Gelatin Storage Vessel PURPOSE: To describe the Installation Qualification of Gelatin Storage Vessel its accessories and to define the Specification of the system in order to: Ensure that the equipment meets the specification as per Design Qualification. Aid verification of the installation as per equipment general arrangement …

Read More »

SOP for operation of de-dusting and polishing machine

A 2 -

SOP for operation of de-dusting and polishing machine Standard Operating Procedure (SOP) Objective To lay down a procedure for operation of de-dusting and polishing machine. Scope This SOP is applicable for operation of de-dusting and polishing machine used to polish the Filled Capsules in Capsule Filling Area to the formulation …

Read More »

SOP on operation of Paste Kettle

A 3 -

SOP on operation of Paste Kettle Standard Operating Procedure (SOP) Objective To lay down the procedure for operation of Paste Kettle Scope This SOP is applicable for operation of Paste Kettle in the formulation plant. Responsibility Production Operator/ Technician – For operation of the equipment. Production Officer/ Executive – To …

Read More »

SOP FOR STABILITY STUDY IN PHARMA INDUSTRY

A 36 -

SOP FOR STABILITY STUDY IN PHARMA INDUSTRY OBJECTIVE: To lay down the procedure for collection, storage and analysis of stability of  samples. SCOPE: This SOP shall be applicable for stability study of samples in Quality Control Department in Pharma Industry. RESPONSIBILITY: Officers/Executive-Quality Control shall be responsible for follow that procedure. …

Read More »