Get ready for an Audit
Get ready for an audit (how to train your employees) Need to get ready for an audit? How do you ensure your organisation is ready for an audit? Do your employees know how to properly respond to an Auditor’s questions? Or was your last mock GMP audit (or internal quality audit/self-inspection) a disaster? If you’re […]
Remote Auditing Guidelines
Remote Auditing Guidelines and Procedures for Remote Audits (ICT, Security) Remote Auditing Guidelines: 10 Commandments for Conducting Remote Audits and offsite inspections Frequently asked questions about Remote Auditing techniques, procedures and guidelines FAQ1: Are remote audits as effective as onsite audits and site inspections? The success of a remote audit depends on numerous factors, including […]
Who conducts GMP audits in pharmaceutical manufacturing and other therapeutic goods production?
In today’s blog supporting the GMP Basics training series, we’ll answer questions relating to “who conducts GMP audits in pharmaceutical manufacturing sectors, medical devices manufacturing, blood and tissue products and other laboratories/bio-science industries”. We will discuss the value of GMP compliance auditing, as well as widely-recognized Regulatory Agencies responsible for GMP (PIC/S) audits in various […]
Medical Supply Chain Risks: Vulnerabilities and the Importance of GMP
Lean manufacturing and ‘just in time’ shipping strategies means medical supply chain risks are an ever-present phenomenon. But medical supply chain risks are particularly heightened during deadly pandemics, such as we’re seeing with Covid19. Medical supply shortages leave us vulnerable to substandard products and falsified medications entering our supply chains. If substandard or fake medical products […]
Top 10 GMP Audit Failure Reasons: FDA and TGA Inspection Findings
Preparing for GMP/PICS Audits by TGA or FDA Inspectors can be a time for introspection. An upcoming GMP audit can even provide inspiration for initiating a continuous improvement initiative, perhaps discussed for months or years yet not yet implemented. So pre-audit preparation is all about focusing on actions, rather than endless discussions. Yet TGA and […]