Tag Archives: Aberdeenshire

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 …

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 …

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 …

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 …

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 …

  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/

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 …

Factory Acceptance Test for Automatic Strip Packing Machine machine name AUTOMATIC STRIP PACKING MACHINE Client Name & Address M/S. document name factory acceptance test PROTOCOL no. SCT/FAT/000 Revision no. 00 MACHINE SR. NO. Table of Contents Sr. No. Title Page No. 1.0         Purpose 2.0         Scope 3.0         Responsibilities 4.0         System description …

Performance Qualification for Automatic Strip Packing Machine TABLE OF CONTENTS Approval Objective Responsibility System Description – Equipment Identification & Description of Operation Standard Operating Procedure Established During Operation Qualification Validation Plan and Methodology Performance Qualification Procedure -1.Effect of Sealing Temperature 2. Effect of Sealing Temperature 3.Effect of Vibration Deviation and …

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 …

SOP on 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 …

WHO Pharma 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 …

SOP for Performance Qualification for Auto Coater 48’’ GMP Model TABLE OF CONTENTS 1.Approval 2.Objective 3.Responsibility 4.System Description – 1.Equipment Identification 2.Description of Operation 5.Standard Operating Procedure  Established During Operation Qualification 6.Validation Plan and Methodology 7.Performance Qualification Procedure Gun Distance from Bed RPM of Peristaltic pump and Spray Rate Effect …

SOP FOR COMPUTER SYSTEM VALIDATION MASTER PLAN Content Approval sheet Introduction Objective Computerized Systems Validation Policy Scope Definitions Role and responsibilities Identification And Categorization of Computerized Systems Validation Strategy and Deliverables Supplier Assessment Quality Risk Management Validation Requirements Documentation Change Control Training Maintenance and Support Document Completion Procedure System Retirement …

SOP For 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 …

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 …

Compression Machine FAT (Factory Acceptance Test) Compression Machine FAT – The purpose is to identify the quality acceptance tests performed at the suppliers’ facilities. Ensuring the compression runs well at startup is an important role of the equipment supplier. Proper design and fabrication are critical, but equally important is a …

SOP For Performance Qualification for Tablet Compression 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 Machine Speed 6.2 …

SOP For MFR For Ornidazole Tablets 500 mg Label Сlaim Manufacturing Formula List of Equipment Manufacturing Instructions Manufacturing Process Flow Chart Manufacturing Process Details Packaging Finished Product Specifications Procedural Changes   Label Сlaim  Product Ornidazole Tablets 500 mg Strength 500 mg Label сlaim Each Film uncoated tablet contains: Ornidazole …………500 …

STABILITY STUDY PROTOCOL THIS PROTOCOL IS: Lisinopril and Hydrochlorothiazide tablets 10+12.5 mg CONTENTS: Each uncoated tablet contains: Lisinopril dihydrate equivalent to Lisinopril 10mg Hydrochlorothiazide                                           12.5mg SHELF LIFE: 24 months DOSAGE FORM: Tablet MANUFACTURED AT: TYPE OF STABILITY STUDIES: Accelerated stability studies 40 + 20C / 75 + 5 …