Drugs

CGMP Violations at McCallum Manufacturing

A 7/24-7/26/17 FDA inspection at McCallum Manufacturing, South Yorkshire, UK, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 4/9 Warning Letter. Specific violations cited in the letter were:

failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release;
failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failing to establish the reliability of component supplier analyses on which the firm relies in lieu of certain tests through appropriate validation of the supplier’s test results at appropriate intervals;
failing to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products;
failing to establish adequate written procedures for production and process control designed to assure that the drug products the company manufactures have the identity, strength, quality, and purity they purport or are represented to possess; and
failing to prepare batch production and controls records with complete information relating to the production and control of each batch of drug product produced.

FDA says it strongly recommends that the firm retain a qualified consultant to assist it in meeting CGMP requirements. McCallum was told to respond with a list of specific actions taken since the inspection to correct the Email Notesviolations and prevent their recurrence, with a timetable for completion.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome