Quality Control/Quality Assurance

Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.

A validation plan developed to support a process unrelated to bio- pharmaceutical manufacture is applied to bio- pharmaceutical processes and systems.

The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.

FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.

After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.

FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.

The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.

A new report gives an overview of the work of the International API Inspection Program.

Premier Pharmacy Labs is voluntarily recalling multiple products because of the potential lack of sterility assurance.

FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.

The European Pharmacopoeia Commission added 19 new monographs and three new chapters and revised 51 monographs and 15 chapters.

RGtimeline/Shutterstock.comParenteral product quality is improving.

Certificates of analysis can be used to monitor the reliability of products and their suppliers, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

This is the first of a series of three articles about validation and technical transfer in the bio- pharmaceutical industry.

The company’s close communication with customers has enabled it to bring advanced pipetting products to market.

Telstar reports that its Boreas, a new 86° ultra-low-temperature freezer, increases average performance by 20%.

The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.

The author reviews operative options for the implementation of a quality oversight and how companies can benefit from this function from a regulatory perspective.

Process validation is an extension of biologics development processes.

Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.

The company is recalling three lots of Hydromorphone HCl Injection USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials because of possibly empty or cracked vials.

The company is recalling Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g manufactured by Gland Pharma Ltd and distributed by Sagent due to out-of-specification impurity results.

In-house experts can help select the right systems and suppliers, making validation and compliance easy, says Siegfried Schmitt, principal consultant at PAREXEL.

FDA enforcement efforts and drug approvals trend upward.

Spectroscopic tools present an alternative method for reliable at-line process monitoring and control.

The company is voluntarily recalling three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial and one lot of Labetalol Hydrochloride Injection, USP, Novaplus because of the potential of cracked glass at the rim of the vials.

The NECC supervisory pharmacist at the center of the 2012 fungal meningitis outbreak was sentenced to 8 years in prison.

This article explores lab data integrity violation trends, as well as a sampling of the latest technologies that can help avoid them.

The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the shortcoming with the contemporary approaches.

Lonza Pharma & Biotech's's Modular Automated Sampling Technology (MAST) platform, which allows for the collection of up to 10 sterile sample sources for automated analysis in multiple analytical devices, won the CPhI Pharma Award 2017 for Excellence in Pharma: Bioprocessing.