Recent Posts

Temperature Mapping

OBJECTIVE: To lay down a procedure for temperature mapping in control rooms to determine the hot and cold spots.  SCOPE: This SOP is applicable for Control areas of  Pharmaceutical company. RESPONSIBILITY: Officer and above of respective department shall be responsible for follow the procedure.. Engineering department shall be responsible for …

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Types of liquid column chromatography ( HPLC),HPLC Separation and HPLC Silica gel

Types of liquid column chromatography ( HPLC),HPLC Separation and HPLC Silica gel Type of liquid column chromatography can be  to classify  on the based the nature of the stationary phase and the separation process, Can be classify  three type Adsorption chromatography Ion-exchange chromatography Size exclusion chromatography Adsorption chromatography In adsorption chromatography the stationary …

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Process analytical technology (PAT) — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

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 …

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SOP for environmental  monitoring of air

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 …

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DESIGN QUALIFICATION (DQ) of Blister Packing Machine (BQS)

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 …

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PERFORMANCE QUALIFICATION PROTOCOL

PERFORMANCE QUALIFICATION PROTOCOL TABLE OF CONTENTS 1.0       PROTOCOL APPROVAL 2.0       OBJECTIVE 3.0       SCOPE 4.0       RESPONSIBILITY 5.0       ACCOUNTABILITY 6.0       METHOD 7.0       RECORDING 8.0       ABBREVIATIONS 9.0       REFERENCES. 10.0     REVISION OF PROTOCOL   1.0     PROTOCOL APPROVAL: Protocol Prepared by: QA is responsible for the preparation of protocol for Performance Qualification of Nitrogen plant. …

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Pass Box for Clean room and it validaton

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 …

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Reynolds number and its importance in water system

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 …

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SOP on operation and cleaning of analytical balance used in aseptic area (Sartorious).

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 …

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Procedure for calibration of balance XS 204 DR. Quality assurance

  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 …

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Design Qualification of Pre-treatment & Purified Water Generation System

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

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Factory Acceptance Test of Automatic Capsule Filling Machine

Factory AcceptanceTest 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 …

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Zhejiang Ludao Technology Co., Ltd.(USFDA warning Letter) 2/23/18

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 …

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Nan San (HK) Pharmaceutical Factory Ltd.(USFDA warning Letter) 2/23/18

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 …

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Homeodynamics, LLC ( USFDA warning Letter ) 2/20/18

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 …

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Alchymars ICM SM Private Limited USFDA warning Letter 2/16/18

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 …

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Nowcos Co.,Ltd USFDA warning Letter 2/14/18

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 :http://pharmaguidances.com/shop/guideline/usfda-warning-letter/

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Wishing a very happy and wonderful Holi 2018 to all Pharmaguidances Visitors

Bright colours, water balloons, lavish gujiyas and melodious songs are the ingredients of perfect Holi. Wish you a very happy and wonderful Holi. our valued customer — add even more protection to your web presence! Website security is something we take very seriously at HostGator. For that reason, as part …

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Auro Pharmacies, Inc. USFDA warning Letter 12/13/16

Auro Pharmacies, Inc. USFDA warning Letter 12/13/16 For Warning Letter Click Here –     For more USFDA warning Letter Visit :http://pharmaguidances.com/shop/guideline/usfda-warning-letter/

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Natura Bisse International S.A. USFDA warning Letter 12/15/16

Natura Bisse International S.A. USFDA warning Letter 12/15/16 For Warning Letter Click Here –     For more USFDA warning Letter Visit :http://pharmaguidances.com/shop/guideline/usfda-warning-letter/

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