Manufacturing

The DME Facility Focus survey revealed best practices for coping with the challenges of aging facilities and implementing facility modernization.

The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.

Industry experts discuss IIoT and its impact on pharmaceutical manufacturing.

Pharmaceutical Technology spoke with Frank Generotzky, plant manager for Baxter BioPharma Solutions’ Halle, Germany facility, about operational excellence at the site.

Capsule filling is a complex process, and the product to be encapsulated must be well developed to ensure mass uniformity.

Although best practices are key, advances in integrated informatics platforms and automation can make it easier to ensure data integrity and improve overall lab efficiency.

As the November 2017 deadline nears, a surprising number of companies still don’t have a serialization plan in place. New programs aim to get them compliant in time.

The UK Stem Cell Bank released validated stem-cell lines for researchers developing novel cell-based therapies for clinical trials.

The article reviews strategies for firms with or without existing in-house capacities and the pros and cons for outsourcing bio/pharmaceutical development and manufacturing.

Having an effective and granular data management process in place will enable companies to meet the requirements of IDMP as well as help usher in a new age of digital-based identification, in which organizations can easily share data across borders.

The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.

Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.

Sanofi and Lonza formed a joint venture to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland.

The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.

The industry is becoming more consolidated, but there needs to be some strategy behind the mergers and acquisitions.

The authors discuss regulatory and patent issues with combination products.

The companies have developed a Level 4 traceability solution to manage pharmaceutical regulatory requirements.

The regulatory agency rejected the medication, citing various issues related to device use.

Momenta’s fill/finish contract manufacturer, Pfizer, was cited in the letter.

FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility’s aseptic processes.

Improved process analytical technology and new ways of thinking seek to enhance measurement and control for next-generation pharmaceutical manufacturing.

The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.

The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.

Soft sensors are powerful tools that can be used along with spectroscopic instruments in on-line measurement.

Aurobindo has added four cell-culture derived biosimilars to its product line.