Chemland Co., Ltd. MARCS-CMS 593158 — February 11, 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 …
Read More »Pharma 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 …
Read More »Pharma 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 …
Read More »Pharma 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 …
Read More »Pharma 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 …
Read More »Pharma 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 …
Read More »Pharma 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 …
Read More »Pharma 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 …
Read More »Pharma 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 …
Read More »Pharma 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 :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Read More »Pharma 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 …
Read More »Strip Packing Machine
Automatic Strip Packing Machine The Strip Packing Machine is designed to pack tablets and capsules within two heat-sealable foil. The machine has been designed to use cellophane Film, Cellophane Lumithene, Aluminum Foil, Polythene Film Laminates, and all heat-sealing papers for sealing. The Tablets / Capsules are charged into the hopper. …
Read More »SOP for Performance Qualification for Automatic Strip Packing Machine
Strip Packing Machine The Strip Packing Machine is designed for packing tablets and capsules within two heat-sealable foil. The machine has been designed to use cellophane Film, Cellophane Lumithene, Aluminum Foil, Polythene Film Laminates, and all heat-sealing papers for sealing purposes. The Tablets / Capsules are charged into the hopper. …
Read More »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 …
Read More »SOP on Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak
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 …
Read More »WHO Pharma Guideline for Basic protective measures against new coronavirus and Myth busters
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 …
Read More »SOP for Performance Qualification for Auto Coater 48’’ GMP Model
Auto Coater 48’’ GMP Model Auto Coater 48’’ GMP Model –The purpose of the Tablet Coating System is to uniformly coat tablets by spraying them with coating materials in a controlled environment & on a moving tablet bed. The hot air entering this equipment will enable efficient drying of tablets, …
Read More »SOP FOR COMPUTER SYSTEM VALIDATION MASTER PLAN
COMPUTER SYSTEM VALIDATION MASTER PLAN The complexity of processes, management of data, and its repeated use are the driving forces for the automation of processes using computerized systems. The systems have the advantages of online data creation, review, approval, archival, retrieval, storage, and utilization and help to reduce the overall …
Read More »SOP For Site Acceptance Test Protocol for Tablet Compression Machine
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 …
Read More »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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