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Sanofi is Coordinating the Lifecycle Management of its Automation Systems to Head Off Manufacturing Breakdowns

Sanofi is focusing more attention on coordinating the lifecycle management of its automation systems to head off the major threats to the continuity of manufacturing operations that ensue from not having a well thought-out planning process in place....

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.

FDA Releases Draft Guidance on Vial Overfills

FDA released a draft guidance in mid-March to better define acceptable practices regarding the overfilling of vials. The guidance, open for comment until June 12, illustrates the best use of overfilling to achieve accurate doses, while preventing contamination.

ICH Q8-11 Oriented Submission and GMP Expectations for Process Validation and Other Quality Issues Taking Shape in Europe

The effort in Europe to update its expectations for process validation (PV) to reflect the quality management principles underpinning ICH Q8-11 moved closer to completion in late February with the issuance of a final guideline on PV submissions for medicinal products and a draft revision of EU GMP Annex 15....

Successful Tech Transfer to a CMO Depends on a Strong Quality Agreement and Open Communication Pathways, FDA Asserts

A detailed description of how a drug product owner will transfer technical knowledge to a contract manufacturer needs to be part of a quality agreement, FDA officials are stressing....

Analyses of Defect Reports by Ireland’s IMB and FDA Highlight Packaging and Labeling as Key Pharma Manufacturing Problem Area

Analyses by the Irish Medicines Board (IMB) and FDA of their data on deviation reporting over the past few years indicate the prominence of packaging and labeling as a problem area in the pharmaceutical manufacturing arena....

ASEAN Adopting QbD Approach to Process Validation Under Singapore Leadership

Singapore is leading an effort by the Association of Southeast Asian Nations (ASEAN) to achieve a harmonized approach to process validation modeled on FDA’s lifecycle approach and the ICH Q8-10 paradigm it embodies....

EMA Guidelines on Process Validation Filings for Biotech Substances and Drug Products Advancing Along with GMP Annex 15 Revision

A guideline on what the European Medicines Agency (EMA) wants to see in marketing authorization applications (MAAs) regarding process validation for biotech drug substances is advancing as a third prong in the agency’s effort to strengthen its PV guidance portfolio....
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