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Sanofi is Coordinating the Lifecycle Management of its Automation Systems to Head Off Manufacturing Breakdowns

Sanofi is focusing more attention on coordinating the lifecycle management of its automation systems to head off the major threats to the continuity of manufacturing operations that ensue from not having a well thought-out planning process in place....

Comment Request on Drug Manufacturer Registration

FDA announced the opening of a comment period on the requirements for drug establishment registration and listing set out in section 510 of the FD&C Act. The comment period ends May 22.

Final Guidance on Unique Facility Identifier Registration

In November, FDA released a procedural guidance, “Specification of the Unique Facility Identifier [UFI] System for Drug Establishment Registration.” The guidance addresses the FDA Safety and Innovation Act (FDASIA) requirements for defining the UFI system for registration of domestic and foreign drug establishments. The guidance notes that at this time, FDA’s preferred UFI for a […]

Final Guidances on Compounding Facilities

FDA issued two final guidances and one draft revision relating to compounding outsourcing facilities in late November. The final guidances address the Registration of Human Drug Compounding Outsourcing Facilities, including the process for registering, re-registering, and de-registering as an outsourcing facility, and the Fees for Human Drug Compounding Outsourcing Facilities, respectively. Also issued was a […]

EMA Final Guideline on Exposure Limits in Shared Manufacturing Facilities

In mid-November, EMA released a final guidance on setting exposure limits for residual active substances in shared manufacturing facilities. The guideline recommends an approach for how to set and present daily exposure thresholds for cross-contamination. The guideline, which comes into effect in June 2015, includes specific considerations for dealing with: ● products with genotoxic potential ● […]

EU GMP Chapters 3, 5, 8, Finalized

The EU Commission has published final versions of EU GMP chapters 3, 5, and 8, which will go into effect in March 2015. The drafts of the chapters were issued in early 2013. Chapter 3 on premises and equipment was revised to: ● emphasize the use of quality risk management (QRM) principles for cross-contamination when […]

Successful Tech Transfer to a CMO Depends on a Strong Quality Agreement and Open Communication Pathways, FDA Asserts

A detailed description of how a drug product owner will transfer technical knowledge to a contract manufacturer needs to be part of a quality agreement, FDA officials are stressing....

Analyses of Defect Reports by Ireland’s IMB and FDA Highlight Packaging and Labeling as Key Pharma Manufacturing Problem Area

Analyses by the Irish Medicines Board (IMB) and FDA of their data on deviation reporting over the past few years indicate the prominence of packaging and labeling as a problem area in the pharmaceutical manufacturing arena....

The Monthly Update for November is Now Available – A Special Report on the Crisis in Pharmacy Compounding and its Implications

In this Monthly Update, IPQ departs from its usual format encompassing the CMC and GMP developments in the U.S., Europe, and internationally to provide a special report on the causes of the health crisis that has unfolded from fungal contamination in pharmacy compounded injectables and the far-reaching implications that extend across the U.S. drug regulatory arena....

New Ranbaxy Site in India Begins Shipping Generic Lipitor to the US

Ranbaxy Laboratories announced in early April that the company has begun exporting its generic version of Lipitor (atorvastatin calcium) oral tablets to the US market from its new “Mohali” manufacturing facility located in Punjab, India. In the first quarter of 2012, the company received approval from FDA to manufacture and market atorvastatin 10mg, 20mg, 40mg […]
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