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November 07, 2005
Pressures to save API are driving formulation developers toward smaller-scale laboratory processes, while pressures to save time put a premium on more- accurate laboratory scale tools.
November 03, 2005
New FDA Guidance on Electronic Common Technical Document Submissions
November 01, 2005
Coordinating validation efforts throughout an organization requires an accurate and timely overview and a validation master plan (VMP).
To implement process analytical technology systems into the current information technology landscape, manufacturers will need to adopt continuously available systems and infrastructures.
Risk analysis and evaluation of software and computer systems is a good tool to optimize validation costs by focusing on systems with high impact on both the business and compliance.
October 01, 2005
Regulatory and compliance requirements are frequently changing, and if that wasn't enough there is also numerous varying regulations across products, services and countries.
August 02, 2005
In 1987, when the US Food and Drug Administration issued its Guideline on General Principles of Process Validation, a young FDA reviewer asked her supervisors.
August 01, 2005
Reading the good automated manufacturing practice (GAMP 4) guide acquaints you with the now classic and almost famous V-model.1 The V-model, originally used for describing a validation workflow of IT and automated systems, is easy to understand and very good at ensuring that the requirements and design are built into the final solution. It is also extremely versatile and can be used for almost any type of validation task you could meet in a development phase.
June 01, 2005
A good electronic records managment program will not just impress regulators. It also can boost profitability.
This article describes the Part 11 requirements that companies must address when automating their quality management processes and offers practical tips for compliance.