Welcome to the fall issue of RF Quarterly in which international experts from the US, EU, and Saudi Arabia examine quality and compliance and their governing regulations, with specific focus on data integrity, quality system design and management, current good manufacturing practice (cGMP), and postmarketing activities in relation to medical devices, pharmaceuticals, and biologics.   Pragmatism, integrity, and QMS Data reliability in all formats and parts of an o...

Issues related to data integrity have been in the news in recent years, often focusing on companies receiving citations from regulatory agencies regarding unreliable computer data. While the laboratory and computer data were the primary focus, data reliability in all formats and in all parts of the operation are critical to ensure products are reliable. While many also think this issue applies only to quality and operations, if the information listed in the regulatory doss...

Quality by design, or the principle of building quality into a product and testing, was introduced in 2011 as process validation guidance. Today it is codified within the Title 21 section 820. The quality management system (QMS) encompasses this principle in all areas of healthcare manufacturing – including drugs, biologics, and devices – and, with compliance, can ensure the safety and effectiveness of all manufactured products. The establishment, implementation, and maint...

Introduction A quality management system (QMS) is one of the five medical device conformity assessment elements. 1 Manufacturers of medical devices are expected to implement, document, and maintain a QMS that “ensures the medical devices it designs, manufactures, and supplies to the market are safe, perform as intended, and comply with the relevant provisions of the regulations in the countries where the product is made available.” 2   Today, a QMS is seen as a ...

This article discusses the phases from the product development to commercialization. Biologics are subject to 21 Code of Federal Regulations in order to meet the criteria established for safety, purity, and potency. Compliance to these regulations should be built based on a quality management system and risk management to capture changes during the product development and process validation phases and prepare a product and facility for inspection readiness. Post commercial...

Most of the 55 guidelines from the International Council on Harmonisation that relate to quality, safety and efficacy, as well as multidisciplinary guidelines, have been adopted among its 10 non-founding members and observers and 30 pharmaceutical companies, according to the results of a new survey.   The survey was designed to monitor the adequacy and level of implementation to ICH guidelines by regulators and industry and complements one released in 2019 on the adopt...

The US Food and Drug Administration (FDA) has issued a new paper  to help shed light on how therapeutic proteins can be produced safely on a continuous manufacturing line.   Continuous manufacturing “is still a novel concept for therapeutic proteins” and more “tangible” examples are needed to implement the program, acknowledged FDA in the report. Further, there are “few published studies” addressing viral inactivation methods for these products.   However, it’s im...

A new report from the US Food and Drug Administration's (FDA's) Office of Pharmaceutical Quality (OPQ) details the top drug quality issues seen in from 2016-2020, with questions of product quality topping the list.   In all, just over a quarter (27%) of all Product Quality Defect (PQD) reports were related to product quality issues, while device and packaging issues together made up another third of the PDQ reports over the 5-year period.   The PQD reports came fro...

The International Council for Harmonisation (ICH) on Tuesday issued its Q13 guideline on continuous manufacturing, making a draft available for public comment.   The long-awaited draft was soon expected, according to an FDA official who gave an update on the status of the guideline at a 14 July CMC Strategy Forum sponsored by the California Separation Science Society (CASSS). (RELATED: Long-awaited ICH continuous manufacturing guideline coming soon , Regulatory Foc...

The International Council for Harmonization (ICH) Q13 guideline on continuous manufacturing is expected to be released for public comment soon, as the US pharmaceutical industry continues slow but steady adoption of this mode of manufacturing.   Cyrus Agarabi, a reviewer in FDA’s Office of Biotechnology Products in the Office of Pharmaceutical Quality, updated attendees on the status of the ICH Q13 guideline at the 14 July CMC Strategy Forum sponsored by the California...

The European Medicines Agency (EMA) on 1 July released for public consultation two draft guidelines to help sponsors of investigational medicinal products (IMPs) for new drugs and biologics decide whether manufacturing changes are considered a “substantial modification” needing prior approval.   These guidelines are connected to the EU regulation No. 536/2014 which came into force on 20 June 2014. The regulation defines a “substantial modification” as any change to a...

New drug shortages in the US decreased in 2020, in part because of the US Food and Drug Administration’s (FDA’s) use of enforcement discretion to ensure an uninterrupted supply of critical medical products during the COVID-19 public health crisis.   Yet, the agency’s new drug shortages report to Congress said that while these actions helped avert shortages in the short-term, more work is needed to improve supply chain resiliency.   This report summarizes the agency...