Quality/GMPs

Drug type, potential sales, and ownership factor in the race to get drugs to market.

Manufacturers face uncertainty over imports, regulatory policies, and field inspections.

Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment.

Moving global manufacturing operations may be more complicated than it appears.

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.

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

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

FDA plans to initiate its quality metrics program as industry continues to push back.

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

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

In 2016, FDA approved 630 ANDAs and tentatively approved 183 ANDAs, the highest number to date, according to the report.

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

FDA granted inotuzumab ozogamicin priority review and accepted its BLA for filing.

In a press release, Momenta announced on Feb. 16, 2017 that Momenta/Sandoz’s fill/finish contract manufacturer, Pfizer, received a warning letter for the manufacture of the 40 mg of Glatopa (glatiramer acetate injection), Momenta’s generic version of the drug Copaxone. Pfizer said in the statement that the warning letter does not affect the production or shipment of the 20 mg version of the drug, which is already approved by FDA.

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

The ICH Q11 Q&A discusses the development and manufacture of drug substances and the selection and justification of starting materials.

FDA approved Valeant’s brodalumab with a boxed warning for suicidal ideation.

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

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.

The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.

Drug companies are pushing Congress to action on funding for FDA programs and staff to expedite drug reviews and approvals.

EMA announces that the European Union’s PAS Register has received its 1000th upload.

Pharmaceutical Technology spoke with Tommy Fanning, head of biopharmaceuticals for IDA Ireland, to get a perspective on how Brexit may affect the pharmaceutical industry.

The company is voluntarily recalling product due to particulate matter.