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Types of liquid column chromatography( HPLC) The type of liquid column chromatography (HPLC) can be classified on the nature of the stationary phase and the separation process. There Can be classified into three types Adsorption chromatography Ion-exchange chromatography Size exclusion chromatography Adsorption chromatography In adsorption chromatography the stationary phase is an …

Process analytical technology (PAT) — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance PAT FRAMEWORK PAT to be a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final …

SOP for environmental  monitoring of air OBJECTIVE  :To lay down a procedure for environmental  monitoring of air. SCOPE  :This SOP shall provide the procedure for monitoring the viable air borne count . RESPONSIBILITY :Microbiologist ACCOUNTABILITY Manager QC/QA PROCEDURE  The microbial environmental conditions  shall be monitored as per defined frequency and …

DESIGN QUALIFICATION (DQ) of Blister Packing Machine (BQS) TABLE OF CONTENT Objective Scope Responsibility Machine description Technical specification Technical specifications and make of sub-components/ bought out items. Details of Utilities Identification of components for calibration Material of construction of all components Safety features and alarms FAT procedure Change control procedure …

PERFORMANCE QUALIFICATION PROTOCOL Pure nitrogen is obtained by removing oxygen from air in two stages. Oil free compressed air is first dehumidified (anhydrous alumina is the desiccant) and is passed through a 0.01 micron filter and then column of Carbon Molecular Sieve (CMS) where oxygen is adsorbed from this column. …

Pass Box for Clean room and it validation Definitions of Pass Box: Pass Box is specifically designed that aids in the material transfer without much personnel movement in clean rooms and also work like a barrier between classified and unclassified area.two types of pass box is used in pharmaceutical industry that …

Reynolds number and its importance in water system Purified water is the most used ingredient in pharmaceutical industries its used directly for the drug manufacturing process and also used for equipment’s cleaning. Purified water and Purified water generation and distribution system is one of the most important and critical part of a pharmaceutical facility and …

SOP on operation and cleaning of analytical balance used in aseptic area (Sartorious) Objective: To lay down a procedure for operation and cleaning of analytical balance used in the aseptic area (Make: Sartorious). Scope The SOP describes the procedure for operation and cleaning of analytical balance used in the aseptic …

  To lay down a procedure for calibration of Weighing Balance XS – 204 DR SCOPE This Standard Calibration Procedure (SOP) is applicable in quality control area. RESPONSIBILITY Quality Control Officer/ Executive ACCOUNTABILITY Head –Quality Assurance PROCEDURE PRE STARTUP Check the cleaning of the weighing balance especially pan & display …

Design Qualification of Pre-treatment & Purified Water Generation System   For More Pharma Updates Visit –https://pharmaguidances.com

Factory Acceptance Test of Automatic Capsule Filling Machine Table of Contents System Information Protocol Details Protocol Approval from Customer Objective of this protocol Scope of this Protocol Definition of FAT and SAT Acceptance Criteria Responsibility Customer Requirements Performance Check Points & Testing Machine Sr. number details AF T Lab Factory …

Zhejiang Ludao Technology Co., Ltd.(USFDA warning Letter) 2/23/18 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning Letter …

Nan San (HK) Pharmaceutical Factory Ltd.(USFDA warning Letter) 2/23/18 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning …

Homeodynamics, LLC ( USFDA warning Letter ) 2/20/18 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning Letter …

Alchymars ICM SM Private Limited USFDA warning Letter 2/16/18 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning …

Nowcos Co., USFDA warning Letter 2/14/18 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/

Bayer Pharma AG USFDA warning Letter 11/14/17 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning Letter Visit …

Hangzhou Facecare Cosmetics Co., Ltd. USFDA warning Letter 11/17/17 For Warning Letter Click Here –   For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/

Dae Young Foods Co., Ltd. USFDA warning Letter 11/20/17 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning …

BBCOS SRL USFDA warning Letter 11/29/17 For Warning Letter Click Here –   For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/