Drugs

CGMP Violations at Czech Interpharm

A 10/12-10/16/15 FDA inspection at Interpharm, Modrany, Czech Republic, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API) and significant CGMP violations for finished pharmaceuticals, according to a 10/18 Warning Letter. Specific deviations and violations included:

failing to prevent unauthorized access or changes to API data, and to provide adequate controls to prevent manipulation and omission of data;
failing to ensure that test procedures are scientifically sound and appropriate to ensure that API conform to established standards of quality and/or purity;
failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in finished pharmaceutical master production and control records or other records; and
failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to ensure that finished pharmaceutical components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.

The letter also says that the firm’s quality system “does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.” It recommends retaining a qualified consultant to assist in remediation and called for (1) a comprehensive investigation into the extent of inaccuracies in data, records, and reporting; (2) a current risk assessment of the potential effects of the observed failures on drug quality; and (3) a management strategy for the firm including details of a global corrective action and preventive action plan.

Interpharm was told to respond with a list of steps it has taken since the inspection to correct the violations and deviations and prevent their recurrence, with a timetable for completion.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome