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Phased Implementation, Reporting Burden Among Industry Focal Points in Initial Feedback on FDA’s Quality Metrics Draft Guidance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at the public meeting held by FDA on August 24 to capture industry’s initial feedback on the agency’s quality metrics draft guidance.

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....

New MHRA Orange and Green Guides

MHRA released the latest edition of its Orange Guide (Rules and Guidance for Pharmaceutical Manufacturers and Distributors) and Green Guide (Rules and Guidance for Pharmaceutical Distributors) in early January. The Orange Guide now includes sections on MHRAs: ● Innovation Office • Compliance and Action Group • risk-based inspection program • gold standard for Responsible Persons, […]

ICH’s Lifecycle Management Initiative Q12 is Targeting the Tough Regulatory Issues, With Patient Supply a Driving Concern; Analytical QbD Also on Expanded ICH Agenda

The ICH Q12 effort to create a more improvement-friendly and harmonized regulatory approach to pharmaceutical product lifecycle management is being driven by concern about the availability and reliability of supply as well as product quality and will address the “tough” regulatory issues involved, GSK CMC Regulatory Strategy VP Moheb Nasr stressed in an update on the ICH initiative in December. Nasr has been appointed to serve as Q12 rapporteur....

CDSCO Increases Personnel to Implement GMP

The Indian drug regulatory agency CDSCO has begun adding inspectors in an effort to increase regulatory oversight. According to Deputy Drugs Controller K. Bangarurajan, India expects “to double the manpower and enhance the lab infrastructure both at the centre and states by the end of 2017.”

New Ph. Eur. Policy on Bacterial Endotoxin Testing

In September, Ph. Eur. released a new policy on testing for bacterial endotoxins. The policy now recommends that new monographs include testing without a limit when a specific method has been described – leaving it up to the manufacturer to determine the appropriate limit. Existing monograph test limits will remain the same.

EU GMP Chapters 3, 5, 8, Finalized

The EU Commission has published final versions of EU GMP chapters 3, 5, and 8, which will go into effect in March 2015. The drafts of the chapters were issued in early 2013. Chapter 3 on premises and equipment was revised to: ● emphasize the use of quality risk management (QRM) principles for cross-contamination when […]

Notice on India’s Regulatory Procedures

Following from a meeting discussing Indian regulatory standards, India’s Central Drugs Standard Control Organization (CDSCO) issued a notice in early August to all of India’s state drug controllers on the standards for conducting GMP inspections. Of note is the need for focus on using a risk-based approach for inspections of product development, quality, stability, process […]

EMA Concept Paper on Validating QC Methods

EMA introduced a concept paper in late June for the creation of a guidance on how a method for quality control may be validated for use in a lab or product development arena.

Success of Eight-Year Amgen Effort to Improve Deviation Investigations and Follow-up Actions Writ Large on Quality Metrics and Bottom Line

The results of an eight-year program at Amgen to improve its deviation investigations and follow-up actions demonstrate how concentrating on finding and addressing root causes can have a substantial impact on a firm’s quality assurance and bottom-line....
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