GMPs/Validation - BioPharm International


What you need to know about regulatory compliance, good manufacturing practices (GMPs), and validation, including evolving regulatory policy and developments in biosimilars.

Achieving More Effective and Efficient GMP Auditing

March 2, 2013

The authors present solutions based on a review of current service offerings and their audit experience.

A Lifecycle Approach to Process Validation

June 1, 2013

A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.

The Lifecycle Change of Process Validation and Analytical Testing

March 1, 2013

BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.

Using a Systematic Approach to Select Critical Process Parameters

July 1, 2012

Harmonized regulations call for a risk-based and systematic approach to evaluating and selecting CPPs.

Continued Process Verification for Biopharma Manufacturing

October 1, 2014

The authors discuss complications of implementing continued process verification and provide recommended approaches.

Quality Agreements for Contract Manufacturers

September 1, 2014

A well-constructed quality agreement can be an important tool to enable effective collaboration between owner and CMO.

Managing Cleaning Validation in Multi-Product Biologics Facilities

September 1, 2014

Developing and maintaining a current master plan for cleaning in multi-product facilities are crucial.

Benefits and Risks of Drug Information on Social Media

July 1, 2014

FDA draft guidances seek to maintain accurate drug information in new media.

Optimizing Human Performance: Part I

July 1, 2014

Achieving excellence in human performance is an achievable system of cultivating and sustaining exceptional levels of performance.



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