Validating pharmaceutical systems

Some of these are must have references for any CSV work, and some are just great resources for those more unorthodox questions.Originally starting as an online forum and blog, Learn About GMP has transformed into one of the most trusted and comprehensive online resources for validation professionals.In order to comply with c GMP, companies are required to record, track, manage, store and easily access various production documents and their detailed change history including Standard Operating Procedures (SOPs), Master Production Batch Record (MPBR), Production Batch Record (PBR), Equipment log books, etc.Download a Insight 21CFR part 11 requires that all systems that govern any c GXP process - including Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs), should be validated.According to the World Health Organization (WHO), the process of qualification and validation is applicable to any aspect of operation that may affect the quality of the product either directly or indirectly.The primary goal of the validation process in the pharmaceutical industry is to have documented proof that quality is part of each and every step of the manufacturing and distribution system, instead of merely testing products at the end of the process.However, with there being so much information out there, how to do you get the answers you need in a time frame that doesn’t slow down your project?

Lack of knowledge about how and what to validate can translate into too much documentation because of uncertainty as to where to draw the line or not enough information because the validation task seems so daunting.

This applies to both validation of product or device software and validation of software used to design, develop or manufacture devices and products.

When using computers or other systems for automated data processing in the pharmaceutical sector, it is important to validate software.

Validation and more specifically, computer system validation (CSV) are areas that require considerable research, thought and attention at the beginning of any project.

Whether it’s verifying your validation strategy, optimizing system testing or improving documentation, the internet provides a wealth of information to guide you in the right direction.


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