Changes to PIC/S GMP
What updates or changes to PIC/S GMP Guidance do you need to understand; and what is the latest version of PIC/S GMP Guidance and PIC/S Annexes?
Top 10 GMP Audit Citations: FDA & TGA Inspections
FDA & TGA GMP Compliance Audit Citations for 2020, 2021, & 2022. Latest FDA inspection trends: common audit…
Medical Device Design
Medical device design should consider – at the earliest of design stages – manufacturing licence application requirements, regulatory compliance requirements, material supply chains and reactivity, and manufacturing at scale.
Are you ‘recall ready’ according to the FDA?
Are you ‘recall ready’? What do regulators such as the FDA, TGA, EMA or MHRA expect in terms of recall preparedness? Recall basics.
Medicine Supply Shortages
Medicine supply shortages relating to the pandemic continue to wreak havoc on treatment continuity. GMP education can help reduce shortages caused by …
10 Key Steps for Managing a GMP Compliance Training Program
Are you an experienced trainer, but new to the Pharmaceutical industry and cGMP compliance training programs? Perhaps you…
FDA Warning Letters on Data Integrity Issues
Batch release decisions — and other product safety evaluations — rely on data integrity. In this pharmaceutical industry…
What is a GMP Inspection?
GMP inspection (Definition) A GMP inspection (‘GMP compliance audit’) will generally involve an onsite visit by a specially-trained…
PIC/s Annex 2A for ATMPs – GMP Regulation Updates
This article provides an introduction to the PIC/S Annex 2A updates in Version 15 in relation to Good…
Get ready for an Audit
Get ready for an audit (how to train your employees) Need to get ready for an audit? How…
Remote Inspections (Offsite Inspections): Auditing Guidelines
Procedures for Remote Inspections (virtual inspections) including ICT and Security Remote Inspections & Offsite Auditing Guidelines & Training…
MHRA GMP Audit – Summary of 2019 – 2020 Inspections (PQS deficiencies)
Top 10 MHRA GMP Audit deficiencies (2019 – 2020 analysis) Summary article for Education Purposes only. If you…
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