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Phased Implementation, Reporting Burden Among Industry Focal Points in Initial Feedback on FDA’s Quality Metrics Draft Guidance

Phased implementation, reporting burden, and the nuances of site versus product reporting were among the focal points of the comments by the various associations appearing at the public meeting held by FDA on August 24 to capture industry’s initial feedback on the agency’s quality metrics draft guidance.

FDA Presence in China

FDA has been facing problems staffing its office in China due to difficulties in obtaining long-term working visas. While the intent has been to get 26 investigators in the two FDA offices in China (IPQ “Monthly Update” September 2011, pp. 27-24), the office currently has ten full-time employees, only three of whom are dedicated to […]

Supply Chain Security Pilot Program

In Mid-May, FDA announced that is looking for firms capable of developing and implementing a pilot program to “explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain” in accord with the Drug Supply Chain Security Act (DSCSA). The announcement is not a solicitation for applications, but rather an attempt […]

FDA Foreign Generic Drug Company Inspections

FDA has made “substantial improvements” to its inspections of foreign generic pharmaceutical manufacturers according to a new report by the Department of Health and Human Services’ (HHS) Office of the Inspector General (OIG). OIG’s early May report was prompted by congressional concerns that FDA lacked sufficient resources to inspect generic pharmaceutical manufacturers, which now make […]

Online GMP Training in India

U.S.-based Underwriters Laboratories will offer online GMP training to drug inspectors in India, Pharmabiz reported in early April. In addition to GMPs, training will cover GLPs and clinical research topics. The training “would definitely help our inspectors understand the nuances of global regulatory requirements and ensure a high degree of quality control for pharmaceutical manufacturers […]

High Foreign Inspection Failure Rate Indicates Need for Better Pharma Risk Modeling and Supplier Oversight Abroad, FDA Compliance Official Stresses

The current high FDA foreign inspection failure rate points to the need for the pharmaceutical industry to develop better risk models and intensify supplier oversight abroad, a senior official at the Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) is stressing....

Implementing the ANSI NSF-IPEC 363 Standard on Excipient GMPs Will Help Ensure Compliance with FDASIA, FMD and EU’s New Excipient Risk Assessment Guideline

Implementation of the ANSI NSF-IPEC 363 standard on GMPs for excipients by pharma and excipient manufacturers will help ensure that they are compliant with the supply chain mandates of the FDA Safety and Innovation Act (FDASIA), the EU Falsified Medicines Directive (FMD), and the newly-completed EU excipient risk assessment guideline....

2015 Planned Guidances

In late February, CDER published a list of new and revised draft guidances it plans to issue in 2015. Some of the topic areas of guidances to be issued are: ● biosimilars ● DSCSA implementation, and ● GDUFA completeness for APIs. Some specific guidances of interest are: ● CGMP data integrity Q&A ● environmental assessment […]

CFDA Plan to Improve Inspections

A plan to improve its regulatory inspections was announced by China’s CFDA in late January. The plan calls for increased inspection capacity, improved training, and better information sharing and coordination.

Drug Controller General of India to Strengthen GMP Enforcement

In late January, the Drug Controller General of India (DCGI) said that they would expand their sample testing program to North Eastern states to better assess drug quality. DCGI had begun testing samples from public healthcare and retail pharmacies to check for quality and efficacy last year in a number of other states.
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