EU GMP Annex 1 Revision: Key Changes for Sterile Drug …
Feb 4, 2025 · A Certificate of Analysis (CoA) or Certificate of Conformance (CoC) Traceability records and validation reports• Change control and deviation management Environmental …
ICH Guideline for Change throughout the Lifecycle of Drugs ...
Jan 17, 2020 · The Latest on Regulations: ICH Guideline to Manage Change throughout the Commercial Lifecycle of Drugs and Combination Products – Part 2
change management of elastomeric packaging components
Jan 2, 2018 · Effective change control systems are important for pharmaceutical packaging materials – especially those in direct contact with drugs. This topic has high visibility in the …
Critical Quality Attributes of drug/CCS and delivery system output requirements provide clarity & define the standards to be met in technical transfers and change control processes.
Effective Change Management through ICH Q12 - West
This blog is about the effective management though ICH Q12 and provides insight as well as a link to a recent OnDemand Webinar done by West experts around the topic.
Orphan drugs – small batches that demand attention - West
May 26, 2016 · West Ready Pack provides a solution for risk mitigation and change control, so the drug product and its packaging maintain a consistent profile from clinical stages through …
Specialist, Product and Compliance Job Details | West …
1 day ago · Manage the document lifecycle for GxP computerized systems, covering design, development, testing, validation, release, and change control documentation Prepare, revise, …
Sr Associate, Quality Engineering Job Details | West …
5 days ago · Monitor Change Control system and provide guidance for proper execution and timely closure of Change Controls and Action items. Understanding and facilitation of Risk …
Metrology Manager Job Details | West Pharmaceutical Services
Nov 26, 2025 · All internal change control procedures incl. e.g. adequate risk assessments are to be followed strictly. Support workstreams to implement / roll-out new innovative processes and …
Solution Architect, D&T, SAP PP
Nov 12, 2025 · Work within and participates in the Change Control process. Conform with and abide by all regulations, policies, work procedures, instruction, and all safety rules.