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
Auditor Training: Remote Auditing Guidelines and Procedures for Remote Audits (ICT, Security) Remote Auditing Guidelines and Auditor Training Courses 10 Commandments for Conducting Remote Audits and offsite inspections FAQ’s about Remote Auditing guidelines, remote auditing techniques and procedures FAQ1: Are remote audits as effective as onsite audits and site inspections? The success of a remote […]
Who conducts GMP audits in pharmaceutical manufacturing and other therapeutic goods production?
Who regulates GMP compliance? In today’s blog supporting the GMP Basics training series, we’ll answer questions relating to “who regulates compliance GMP?” We’ll provide a brief overview and list of Regulatory Authorities that conduct GMP audits in pharmaceutical manufacturing sectors, medical devices manufacturing, blood and tissue products and other laboratories/bio-science industries. We will also discuss […]
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 […]