Quality Assurance/Quality Control

Mar 20, 2018
By Pharmaceutical Technology Editors
The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.
Mar 15, 2018
The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates.
Mar 14, 2018
A previously published article presented difficulties with the revised European guidelines on sterile manufacturing. The authors included a brief summary of the comments developed on the draft document. This article expands upon that summary, outlines the authors' rationale, and highlights the most difficult aspects of the revision draft.
Mar 06, 2018
By Pharmaceutical Technology Editors
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.
Mar 06, 2018
By Pharmaceutical Technology Editors
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.
Mar 02, 2018
Pharmaceutical Technology
Stability testing on APIs/finished drug product helps define optimal drug packaging for shelf-life storage.
Mar 02, 2018
Pharmaceutical Technology
Robert Iser of PAREXEL Consulting answers questions regarding the regulatory expectations of quality agreements and how companies can ensure the quality and safety of their products.
Mar 02, 2018
Pharmaceutical Technology
In-house experts can help select the right systems and suppliers, making validation and compliance easy, says Siegfried Schmitt, principal consultant at PAREXEL.
Feb 23, 2018
By Pharmaceutical Technology Editors
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.
Feb 02, 2018
Pharmaceutical Technology
While more companies are embracing taggants, researchers are developing new technologies that will be extremely difficult to reproduce.
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