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PharmTech GMP_validation
GMPs/VALIDATION ARTICLES
Understanding the Cleaning Validation Lifecycle
The cleaning validation lifecycle includes assessment, development, validation, and monitoring.
Defining the Sterile Barrier of Complex Drug Delivery Systems
New injection-delivery systems with multiple closure points pose challenges for container closure integrity testing.
Trends and Best Practices in Visual Inspection
Using best practices for manual or automatic inspection can improve the inspection process.
Separation of Compliance and Performance Under FDASIA
The root cause of drug shortages is mismanagement of variation.
Complying with Revised USP Chapters on Weighing
USP's revised Chapters 41 and 1251, which became official in December 2013, have new requirements for weighing, including balance calibration and testing.
GMPs/VALIDATION NEWS
Ranbaxy Suspends API Shipments from Two Plants in India
Daiichi Sankyo announced suspension of API shipments from Ranbaxy's Toansa and Dewas plants; issues apology to stakeholders.
FDA Commissioner to Meet with Indian Regulatory Authorities
In first official visit to India, FDA commissioner to discuss ongoing collaboration on drug programs.
FDA Prohibits Another Ranbaxy Facility from Producing Drugs for US Market
FDA adds Ranbaxy's Toansa, India facility to existing consent decree, prohibiting distribution of APIs from that location
FDA Launches Online Portal for Advisory Committee Nominations
Online portal accepts nominations for FDA advisory committee membership.
EMA Adds Statements of GMP Non-Compliance to EudraGMDP
EMA has launched a new version of the EudraGMDP database, which includes the publication of statements of non-compliance with good manufacturing practice.
GMPs/VALIDATION RESOURCES
Process Validation Strategy Templates
This strategy/validation plan defines what needs to be validation (i.e. equipment, systems, and processes) and how validation needs will be met for a given project.
Example Validation Master Plan
This Validation Master Plan serves as a summary of the overall strategy for the validation of a facility.
Traceability Matrix for Process Validation | IVT
Take a lesson for the CSV group. Add a traceability matrix to your documentation.
CROs Face Issues with Talent Retention
A recent survey shows that talent retention is an issue on industry level for contract research organizations (CROs), particularly for CROs located outside the United States.
Novartis Receives EU Approval for Juvenile Arthritis Treatment
Novartis Ilaris, an interleukin-1 beta inhibitor, treats active system juvenile idiopathic arthritis.
GMPs/VALIDATION EVENTS
Apr 23, 2014 - Apr 25, 2014
15th Annual Computer and Software Validation Forum
Jun 4, 2014 - Jun 5, 2014
3rd Annual Forum on Manufacturing Execution Systems (MES) for Device and Diagnostics
Jun 17, 2014 - Jun 19, 2014
Product Complaints for Bio/Pharmaceuticals and Medical Devices
Aug 14, 2014 - Aug 15, 2014
MES 2014
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