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Annual Report – FY 2018

A comprehensive annual overview of the most frequently cited cGMP violations from actual FDA inspections. This 30-page report graphically depicts inspection observations by category and provides specific detail from actual 483 reports.

Annual Report – FY 2019

A comprehensive annual overview of the most frequently cited cGMP violations from actual FDA inspections. This 30-page report graphically depicts inspection observations by category and provides specific detail from actual 483 reports.

Annual Report – FY 2020

A comprehensive annual overview of the most frequently cited cGMO violations from actual FDA inspections. This report graphically depicts inspection observations by category and provides specific details from actual 483 reports.

FY 2023 Review of FDA Inspections

[…] *** 68 21 CFR 211.113(b) Procedures for sterile drug products Procedures designed to prevent […]

Annual Report – FY 2021

The GMP Trends® Annual Report is a review of FDA Inspection Observations for the previous […]

FY 2022 Review of FDA Inspections

[…] *** 40 21 CFR 211.113(b) Procedures for sterile drug products Procedures designed to prevent […]

GMP Sample Newsletter 2023

[…] that are used in the manufacturing of sterile drug products. You sample the water […]

GMP-Sample-Newsletter-2024

[…] that are used in the manufacturing of sterile drug products. You sample the water […]

Issue #1132

[…] actual 483 observations pertaining to quality systems, manufacturing controls, and medical device manufacturers. This […]

Issue #1077

Highlights actual 483 observations pertaining to quality systems, manufacturing controls and medical device manufacturers. This […]