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Clarifying Questions Upfront is Key in Process Validation, US and EU PV Principles in Alignment, CDER’s McNally Stresses 

FDA is advising industry to ensure that their process validation teams clearly articulate and document the questions they are seeking to answer up front, prior to collecting data or executing process qualification (PQ).

IPQ Monthly Update, June 2015

In focus are: ● FDA’s CDER on the role of the control strategy in application approval recommendations and the challenges reviewers face in piecing the story together ● the key role a novel excipient played in the development of a new insulin inhalation product and the broader implications of the experience, and ● ICH’s effort to address the pressing questions on API CMC and GMP through Q&As on Q7 and Q11....

ICH’s API Coverage Deepening with a Newly Released Q&A on Q7 and a Q11 Q&A Project on Starting Materials Underway

A newly released Q&A from ICH on its active pharmaceutical ingredient (API) GMP guideline Q7 and another Q&A being prepared on the more recently issued API development and submission guideline Q11 are intended to address issues that have surfaced in implementing the two guidelines and drive more uniform interpretation across industry and regulators worldwide....

APIs from Indian Firm Banned in EU

A Slovenia inspection team representing EMA discovered issues at Polydrug Laboratories in Maharashtra, India that have led to suspensions of all of the firm’s CEPs. According to the EudraGMDP report, 17 deficiencies were found, including five “major” deficiencies, involving: ● customer complaints “deliberately” unregistered in the official logbook ● storage of quality documents in an […]

EU Bans Sterile APIs from Chinese Firm

An April inspection of a Zhuhai United Laboratories sterile API site in Guangdong, China by Romanian inspectors representing EMA has resulted in some of the firm’s amoxicillin products being banned from sale in the EU. The firm claims to be the world’s largest manufacturer of the API for the antibiotic amoxicillin. According to the inspection […]

EC Draft on Sodium-Containing Excipients

The European Commission (EC) released a draft revision of the “Excipients in the label and package leaflet of medicinal products for human use” (CPMP/463/00 Rev. 1) annex covering the use of sodium-containing excipients. The nine-page draft, in the form of a Q&A document, was released in late June for a three-month public consultation. The Q&A […]

MHRA Business Plan

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) 2015/16 business plan was published at the end of June. Key strategic activities for 2015-16 include: ● bringing innovation and new products speedily and safely to patients ● strengthening surveillance ● ensuring safe medicines and devices and secure supply in globalized industries, and ● achieving a […]

India Drug Regulator Upgrades and Rename

India’s drug regulator, the Central Drug Standard Control Organization (CDSCO) has made a proposal to the government’s cabinet of ministers to upgrade the agency’s regulatory oversight using the US FDA as a model, and will rename it the Central Drug Administration (CDA), the Hindustan Times reported. The draft note also suggests that CDA should fall […]

EMA Concept Paper on Import Guidance

In mid-May, the EMA’s GMP/GDP Inspectors Working Group (IWG) released a concept paper on providing additional guidance on the GMP requirements that are of particular relevance to importers and on the extent those requirements apply to the different entities involved in importation activities. The IWG foresees that the guidance would take the form of a […]

EMA/HMA Joint Strategy

The EMA and the Heads of Medicines Agencies (HMA) released their first joint strategy document in early April, entitled the “EU Medicines Agencies Network Strategy to 2020.” The five-year EMA/HMA plan addresses the quality of medicines, supply chain integrity, and confronting the issues of antimicrobial resistance using “a more coordinated approach than was used in […]
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