ISPE announced the release of its latest Guide, I SPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry . The Guide focuses on how Knowledge Management (KM) can enable a more effective Pharmaceutical Quality System (PQS). The...
ISPE announced the release of its latest Guide, ISPE Good Practice Guide: Maintenance, 2nd Edition. The Guide describes current established good practices and seeks to provide a practical and consistent interpretation of the required elements of a...
Maintenance can impact both the quality of products and the compliance of pharmaceutical processes. Maintenance programs have long been recognized as critical to the success of the operations they support.
ISPE announced the release of its latest Guide, ISPE Good Practice Guide: Equipment Reliability . This Guide offers best practices with respect to equipment reliability, addresses specific opportunities for the pharmaceutical industry beyond the...
ISPE announced the release of its latest Guide, ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System . This is the first in the planned four-part series that seeks to improve the state of pharmaceutical quality and ensure sustainable...
The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System provides a quality management framework for assessing and advancing CAPA system maturity level by evaluating several key components.
ISPE announced the release of its latest Guide, ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design . This Guide was written by a group of experts and reviewed by regulators and practitioners in the field, and supports a holistic data...
ISPE announced the release of its latest Guide, ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, and Controls. The Guide was written by a group of experts and reviewed by regulators and practitioners in the field, delivering a...
Why is commissioning & qualification important? Is qualification the same as verification? What is a key factor when implementing a risk management approach to commissioning and qualification? What is a common...
Regulatory compliance of critical utilities is essential to maintaining overall facility compliance. Due to their hidden nature, critical utilities can become vulnerable to non-compliance and significantly increase the...
