Category: CQV

A review of warning letters posted on September 10, 2013, to the FDA website was conducted.  Four of thirteen warning letters were issued by CDRH with a subject of Quality System Regulation for Medical Devices/Adulterated.  Twenty-seven violations were identified at these four manufacturers.  A break-down of the identified violations follows: Citation         […]

What happens when a FDA regulated company has repeated failures during inspection or when promised corrective action does not appear to be effective? In a recent warning letter, FDA identified four citations: While not numbered as an observation, the FDA also commented that the firm does not always follow their current SOPs. Finally – FDA made […]

– Bruce Beck Project information is the data and documentation generated by a number of sources including engineering, vendors, automation groups, contractors and operations as well as the C&Q team over the course of the project.  Accurate, complete information in the form of data, documentation and drawings is fundamentally important to not only the project […]

What happens when a firm obtains out of specification results? 21 CFR 211.192 states: All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy […]

EMA released the Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container on 6 March 2019, and it will go into effect 1 October 2019. The guideline is available here. This document addresses: 4. General requirements  4.1. Requirements for the manufacture of sterile medicinal products and sterile components  4.1.1. Steam sterilisation  4.1.2. […]

FY 2016 Drug Inspection Summary From October 1, 2015 to September 30, 2016, 691 Form 483’s were issued to Drug Manufacturers, which resulted in 3,342 individual citations. The frequency of citations ordered by subpart of 21 CFR 211 provides the following insight as to inspection trends identified by FDA for Fiscal Year 2016. As you can […]

FDA Inspection Trends, FY 2015 Did you know that in FY 2015 the US FDA completed 5,615 GMP inspections of registered drug and device establishments?  The total number of inspections has decreased by 6.3% since FY 2013.  However, the number of foreign inspections as a percent of total inspections per fiscal year have risen from […]

In a recently posted FDA warning letter to OTC Manufacturer, the OTC manufacturer in Canada received 6 observations. This is one of the few warning letters where FDA calls out executive management for failure to provide oversight and control of drug manufacturing. The OTC firm had promised actions from prior inspections – but failed to implement […]

Buildings and equipment used in the manufacture, processing, packaging, holding or storage of drug product are subject to the regulations set forth by the FDA in 21 CFR Part 211.  These regulations are considered the minimum current good manufacturing practices (cGMPs), for the manufacture of human and animal drug products.  Commissioning and qualification of these […]

In a recently posted warning letter, the manufacturer of over-the-counter (OTC) oral rinses and oral moisturizing drug products received a citation concerning 21 CFR 211.42. The firm used the same manufacturing equipment to manufacture the GMP over-the-counter oral rinses and oral moisturizing drug products and numerous non-pharmaceutical materials (Co-Manufacturing) in your facility, including an industrial car care […]