USFDA Archives - Pharmaceutical Guidelines

Aurobindo Pharmaceutical USFDA Warning Letter- 2022

Aurobindo Pharmaceutical Limited MARCS-CMS 618091 — JANUARY 12, 2022 January 12, 2022 WARNING LETTER Delivery Method:VIA UPSProduct:Drugs Recipient: Mr. Narayanan GovindarajanAurobindo Pharmaceutical Limited Floor No.’s 22, 23 & 24 Galaxy Plot No-1, Survey No: 83/1, Hyderabad Knowledge City Raidurg Panmaktha, Ranga Reddy District Hyderabad500081 Telangana IndiaIssuing Office:Center for Drug Evaluation and Research | CDER United States Warning Letter 320-22-10 January …

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Data Integrity Problems as Main Topic of FDA Warning Letter

FDA Warning Letter

Data integrity continues to be one of the main topics during FDA inspections. One of the contributing causes for the warning letter to the American company Vi-Jon was the lack of controls to ensure the integrity of electronic data as well as insufficient access control to IT systems. Based on an inspection which was carried …

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Supporting Clean Areas & Clean Areas Separation in Aseptic Product Manufacturing – USFDA

Aseptic Processing Guidelines

Supporting Clean Areas Supporting clean areas can have various classifications and functions. Many support areas function as zones in which nonsterile components, formulated products, in-process materials, equipment, and container/closures are prepared, held, or transferred. These environments are soundly designed when they minimize the level of particle contaminants in the final product and control the microbiological …

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GUIDE TO INSPECTIONS OF HIGH PURITY WATER SYSTEMS

Microbiology

GUIDE TO INSPECTIONS OF HIGH PURITY WATER SYSTEMS Note: This document is reference material for investigators and other FDA personnel. The document does not bind FDA, and does no confer any rights, privileges, benefits, or immunities for or on any person(s). This guide discusses, primarily from a microbiological aspect, the review and evaluation of high …

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How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -II)

Uncategorized

How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -II) Out Of Specification( OOS ) :- The all test results which goes outside the specification or acceptance criteria established in Drug Dossiers, Drug Master files, Its official Pharmacopeias, Or the manufacturer comes Under Out of Specification( OOS ). We have seen in last …

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How to Investigate Out Of Specification(OOS) Test Results….???( USFDA Phase -I)

Uncategorized

How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -I) Out Of Specification(OOS) :- The all test results which goes outside the specification or acceptance criteria established in Drug Dossiers, Drug Master files, Its official Pharmacopeias, Or the manufacturer comes Under Out of Specification(OOS). What USFDA guideline says about Investigation of Out …

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What is Data Integrity In Pharmaceutical Industry…???

Uncategorized

What is Data Integrity In Pharmaceutical Industry…??? MHRA says,”The way regulatory data is generated has continued to evolve in line with the ongoing development of supporting technologies such as the increasing use of electronic data capture, automation of systems and use of remote technologies; and the increased complexity of supply chains and ways of working, …

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