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FDA releases analysis on drug product quality in 2022

European Pharmaceutical Review

Therefore CDER stressed the need to maintain labelled storage conditions and monitor those conditions throughout the drug supply chain. Reflecting on five years of quality control for nitrosamine impurities Warning Letters In FY2022, the FDA issued 72 CGMP-related warning letters to pharmaceutical manufacturing sites.

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Line clearance procedure and reconciliation in GMP

GMPSOP

Proper line segregation involves physically separating different lots of starting materials, labeling components, and printing matters, many of which look similar. Before filling and labeling, you should thoroughly examine the filling line using a standard operating procedure. Please look at the labeling operation in the picture below.

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Pharmaceutical sampling procedures for non-sterile products

GMPSOP

Table of Contents Importance of sampling in pharmaceutical industry Pharmaceutical sampling procedures are carried out during and at each major processing step during the manufacturing to ensure the highest quality is attained. Pharmaceutical sampling procedures ensure all of the above. as their visual aids.

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NHC Submits Comments on FDA Draft Guidance on AI to Support Regulatory Decision-Making for Drugs/Biologics

Putting Patients First Blog

AI in Drug Discovery and Preclinical Development The integration of AI and ML into drug and biologic development presents transformative opportunities while introducing critical regulatory and ethical challenges. 3 ,4 The NHC is uniquely positioned to provide input on this issue.

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What are the elements of quality control process in pharmaceuticals

GMPSOP

Typical flow of samples in a quality control laboratory The quality control laboratory receives samples that are collected randomly at the beginning, middle, and end of manufacturing processes. GMP requires that all critical steps of manufacture are reliable or validated. This naturally includes laboratory test methods.

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Corrective and Preventive Action (CAPA) Procedure for GMP

GMPSOP

As a preventive action, the supplier of the carton was contacted and presented the issue. The supplier has taken action in their manufacturing process to improve the printing area which should stop the recurrence of the printing defect in the future. . A fresh lot of unprinted cartons was issued for printing.

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Validation master plan (VMP) – when and how to create one?

GMPSOP

Validation master plan flowchart Key elements to consider during validation activities We have told you the common validation examples typically undertaken by the pharmaceutical manufacturing facility. Also, we have demonstrated the five stages of the validation lifecycle.