FDA Warning Letters on Data Integrity Issues
Batch release decisions — and other product safety evaluations — rely on data integrity. In this pharmaceutical industry article, we’ll explore 2021 and 2022 FDA Warning Letters on data integrity issues in the pharmaceutical manufacturing sector. We’ll also discuss: Why data integrity controls become more critical during a pandemic. Why data governance measures are essential […]
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 […]
Auditing FAQs: Guidelines for Offsite Inspections
Procedures for Remote Inspections (virtual inspections) including ICT and Security Auditing Guidelines and Auditor Training Courses 10 Commandments for Conducting Remote Audits and offsite inspections Auditing FAQ’s about Remote Auditing guidelines, remote auditing techniques and procedures FAQ 1: Are remote inspections as effective as onsite inspections when evaluating GMP compliance? The success of a remote […]
Software as a Medical Device (SaMD)
FAQs about Software as a Medical Device (SaMD) Medical-purpose software development is a rapidly growing industry. As with other medical devices, medical-use software offers potential benefits to patients. SaMD can save lives by improving diagnostic capacities, monitoring treatment efficacy, and guiding critical-care decisions. Review the online GMP compliance course for SaMD designers, medical-use software manufacturers […]
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 […]
Does my product require FDA approval? FDA Pre-Approval Requirements
How can you tell if your product needs pre-approval from the FDA before you can market it to the public? This blog gives you a general idea of the types of products and additives that require pre-approval from the FDA prior to marketing (going to market). You’ll need to consult the FDA and visit the […]