Tuesday , May 26 2020

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USFDA Warning Letter for Acino Products, LLC

Acino Products, LLC MARCS-CMS 589471 — February 10, 2020 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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USFDA Warning Letter for Guangzhou Tinci Materials Technology

Guangzhou Tinci Materials Technology Co., Ltd. MARCS-CMS 592199 — January 23, 2020 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 …

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USFDA Warning Letter for Windlas Healthcare Private Limited

Windlas Healthcare Private Limited MARCS-CMS 595494 — March 10, 2020   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 …

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USFDA Warning Letter for Cipla Limited

Cipla Limited MARCS-CMS 597511 — February 25, 2020 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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USFDA Warning Letter for Hangzhou Linkeweier

Hangzhou Linkeweier Daily Chemicals Co., Ltd. MARCS-CMS 595492 — March 13, 2020 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 …

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USFDA Warning Letter for Derma Pharm

Derma Pharm A/S MARCS-CMS 596662  March 10, 2020 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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USFDA Warning Letter for Pfizer Healthcare India Private Limited

Pfizer Healthcare India Private Limited MARCS-CMS 594972 — March 25, 2020 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 …

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USFDA Warning Letter for Trilogy Laboratories, LLC

Trilogy Laboratories, LLC MARCS-CMS 595087 — March 05, 2020 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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USFDA Warning Letter for FICOSOTA LTD

  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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USFDA Warning Letter Global Treat Srl

Global Treat Srl MARCS-CMS 596638 — March 31, 2020 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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Factory Acceptance Test for Automatic Strip Packing Machine

Factory Acceptance Test for Automatic Strip Packing Machine machine name : AUTOMATIC STRIP PACKING MACHINE     Client Name & address : M/S.     document name : factory acceptance test     PROTOCAL no. : SCT/FAT/000     Revision no. : 00     MACHINE SR. NO. :   …

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Performance Qualification for Automatic Strip Packing Machine

Performance Qualification for Automatic Strip Packing Machine TABLE OF CONTENTS 1.0 Approval 2.0 Objective 3.0 Responsibility 4.0 System Description 4.1 Equipment Identification 4.2 Description of Operation 4.3 Standard Operating Procedure Established During Operation Qualification 5.0 Validation Plan and Methodology 6.0 Performance Qualification Procedure 6.1 Effect of Sealing Temperature 6.2 Effect …

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Questions and Answers on coronaviruses (COVID-19) WHO

Questions and Answers on coronaviruses (COVID-19) WHO 1.0 Question : What is a coronavirus? Answer :  Coronaviruses are a large family of viruses which may cause illness in animals or humans.  In humans, several coronaviruses are known to cause respiratory infections ranging from the common cold to more severe diseases …

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Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak

Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home Published 9 April 2020 From: Medicines and Healthcare products Regulatory Agency Contents 1. Existing electronic systems 2. Paper documents that were approved with …

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WHO Guideline for Basic protective measures against new coronavirus and Myth busters

To prevent infection and to slow transmission of COVID-19, do the following: Wash your hands regularly with soap and water, or clean them with alcohol-based hand rub. Maintain at least 1 metre distance between you and people coughing or sneezing. Avoid touching your face. Cover your mouth and nose when …

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Performance Qualification for Auto Coater 48’’ GMP Model

TABLE OF CONTENTS 1.0 Approval 2.0 Objective 3.0 Responsibility 4.0 System Description 4.1 Equipment Identification 4.2 Description of Operation 4.3 Standard Operating Procedure Established During Operation Qualification 5.0 Validation Plan and Methodology 6.0 Performance Qualification Procedure 6.1 Gun Distance from Bed 6.2 RPM of Peristaltic pump and Spray Rate 6.3 …

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COMPUTER SYSTEM VALIDATION MASTER PLAN

COMPUTER SYSTEM VALIDATION MASTER PLAN Document No.   Version No. 00 Effective Date   Review Date   Total No. of Pages   INDEX  S. No. Content Page No. 1.0 Approval sheet 2.0 Introduction 3.0 Objective 4.0 Computerized Systems Validation Policy 5.0 Scope 6.0 Definitions 7.0 Role and responsibilities 8.0 Identification And …

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Site Acceptance Test Protocol for Tablet Compression Machine

Site Acceptance Test Protocol for Tablet Compression Machine machine name :  35 STN “B” TOOLING TAB COMPRESSION  MACHINE     Client Name & address :     document name : SITE ACCEPTANCE TEST PROTOCOL     PROTOCAL no. :     Revision no. : 00     MACHINE SR. NO. …

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SOP to prevent the spread of COVID 19 infection at workplace

1.0 OBJECTIVE: To lay down a Standard Operating Procedure to prevent the spread of COVID 19 infection at the workplace. 2.0 SCOPE: This SOP is applicable to cover all the individuals entering into plant 3.0 RESPONSIBILITY: HR department to verify and ensure compliance of the procedure. All individual reporting to …

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Factory Acceptance Test for Tablet Compression Machine

machine name : 35 STN “B” TOOLING TAB, COMPRESSION MACHINE     Client Name & address :     document name : factory acceptance test     PROTOCAL no. :     Revision no. : 00     MACHINE SR. NO. :   Table of Contents 1.SYSTEM DESCRIPTION 2.SYSTEM CHECKES …

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