<span class="archive__title-prefix>Posts Categorized:</span> Conference Spotlight

Health authorities rely on inspections of pharma manufacturing facilities as a critical element of the drug approval process and insurance of compliance to Good Manufacturing Practices (GMPs). However, during the COVID-19 pandemic, travel and in-person visitation have been restricted, creating challenging scenarios for health authority inspections and creative solutions.Inspection alternatives used by the agencies include […]

The May 26, 2021 deadline for compliance with the European Union (EU) Medical Device Regulation (MDR) is fast approaching. For combination products with a device component—which are covered under this regulation—it is imperative that gap assessments have been completed and action plans implemented by that date to ensure the products stay on the market in […]

What happens when a deviation investigation into microbiological contamination in a water system determines the wrong root cause?  Then, what happens if a corrective action is implemented that results in the contamination immediately coming back worse than it was and now also showing up as well in product samples?  And what does a pharma company […]

The animal health industry has long voiced concerns over some of the difficulties of marketing products in the European Union. These include: High administrative burden produced by the need to translate and produce packaging and product inserts in national languages for smaller marketsWork required for submitting variations and the time they take getting approvedRequirements for […]

At the 2020 ISPE Europe Annual Conference held virtually in September, Vladislav Shestakov, Director and Deputy Head of the Russian State GMP Inspectorate—the State Institute of Drugs and Good Practices (SID&GP)— weighed in on the following: Remote or so-called distance auditsHow his inspectorate conducts such auditsHis agency’s views on international cooperation and harmonization Question (paraphrased): […]

Combination products—combinations of drugs, biologics, or devices that are physically, chemically, or otherwise produced as a single entity, such as prefilled syringes, metered dose inhalers, or drug-eluting stents—have become important healthcare tools in the last decade. Regulations and guidances affecting these products have been promulgated since the final GMP rule covering them was finalized in […]

While the number of drug GMP warning letters declined by about 30% in FY2019, the number of import alerts, regulatory discretions, and regulatory meetings increased dramatically through July 2020 compared to FY2019. At the 2020 PDA/FDA Joint Regulatory Conference held virtually in September, Director of the Office of Manufacturing Quality (OMQ) in CDER’s Office of […]

FDA is proposing the use of a model that would measure and rate the maturity of a pharma company facility’s quality management system. This model would eventually incentivize companies to improve their ratings in exchange for regulatory concessions such as flexibility in post-approval change management. FDA would not disclose a company’s rating, although companies could […]

Are you aware of the changes to the Chinese Pharmacopoeia 2020 edition, which became effective at the end of December 2020? Zonghua Song, PhD, Deputy Director, Chinese Pharmacopoeia Commission, provided an overview of the Chinese Pharmacopoeia 2020 edition via a prerecorded talk at the virtual 2020 PDA Pharmacopeia Conference. [Related: Are you responsible for regulatory […]

FDA’s vision of biomanufacturing in the future includes facilities that are simplified in design with reduced floor space and that are cloneable with closed single-use-systems. The equipment used should provide for flexibility, with more modular reconfigurable units and smaller reactors with processes that remove the need for stainless steel site Clean-In-Place (CIP) and Steam-In-Place (SIP) […]