Regulatory/GMP Compliance

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

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

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

Process conditions can corrode stainless-steel surfaces, necessitating corrective and preventive maintenance.

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

FDA's Warning Letter to an Indian API manufacturer alleges cGMP violations and improper cleaning and validation

Laboratory tests can determine critical cleaning parameters for passivation treatments used to prevent rouge on GMP stainless-steel equipment.

Drug manufacturers need to work closely with excipient suppliers to ensure supply chain safety.

Reducing regulatory roadblocks requires more than the stroke of a pen.

The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates,  discusses how to ensure sterility when manufacturing small-scale parenteral batches.

User fee reauthorization is crucial to implementing the Cures Act and refining the approval process.

The authors look at challenges and considerations to continuously improve inspection efficiency.

FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.

As the date for implementation of the Drug Supply Chain Security Act approaches, bio/pharma companies and contractors should focus on key areas.

FDA cites Sato Yakuhin Kogyo Co., Ltd. with data integrity violations after a June 2016 inspection of its Kashihara City facility.

The presentation details the addition of triethylamine to the guideline on toxic solvents.

An FDA guidance on biosimilar naming garnered mixed responses from the Biosimilars Forum, the American College of Rheumatology, and Pfenex.

The partnership will focus on providing practical information to clients on the development of biologics and vaccines.

The company was cited by FDA for violations of sterile processing GMPs.

FDA’s Center for Drug Evaluation and Research (CDER) approved 22 new molecular entities (NMEs) in 2016, according to a January 4, 2016 release from the agency. Of the 22 NMEs, 12 were large-molecule therapeutics. Of CDER’s 45 novel drug approvals in 2015, 17 were considered large-molecule therapeutics (larger than 900 Daltons).In 2016, 11 of the 12 large-molecule drugs that were approved were biologics. This includes seven monoclonal antibodies (mAbs), one hormone, and three DNA-derived medications. The remaining large-molecule medication was a diagnostic agent.

A four-stage process to successfully make the switch from paper to electronic batch records is presented.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has conducted an annual survey of GMP/GDP inspections at sites and affiliates among its member companies from 2003 until the present time. This article describes findings of the EFPIA annual survey of site inspections among its member companies.

The agency has published its refuse-to-receive standards guidance for abbreviated new drug applications.

The companies entered a manufacturing agreement for the future commercial production of Lenti-D and LentiGlobin product candidates.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on a limited budget.

Airlocks, gowning rooms, and transition spaces have different uses and should be considered separately in cGMP pharmaceutical facility design.

Pharmaceutical companies must see regulators as partners in their efforts to provide safe and effective therapies worldwide.

FDA has revised its draft guidance to provide greater clarity and focus. This version would establish an initial voluntary phase to allow regulators and industry to focus, first, on a limited set of metrics.

FDA issued a warning letter to Srikem Laboratories Pvt. Ltd. for data integrity violations