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 […]
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 Manufacturing Practice (GMP) requirements for Advanced Therapy Medical Products (ATMPs). PIC/s guidance on ATMPs and biological medicines: what changed in PIC/S Version 15? GMP requirements for the production of ATMPs (in Annex 2A) are now in a […]
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 […]
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 are facing a GMP audit by the MHRA, you’ll want to ensure ALL of your quality systems are fully compliant with current Good Manufacturing Practice (cGMP). That noted, which components of your pharmaceutical or medical device quality […]
HVAC system specifications and requirements: pharmaceutical manufacturing
When it comes to HVAC system specifications and requirements for pharmaceutical facilities – including cleanroom designs – getting your HVAC system right is crucial for product quality and GMP compliance. If your pharmaceutical facility architects (or construction managers) do not fully understand GMP, you’re risking product contamination issues and future GMP inspection findings (GMP audit […]
Good Clinical Practice (GCP) Inspections Program
New online courses available for clinical trials and GCP compliance training. The latest online training courses at www.onlinegmptraining.com relate to drug safety through GCP (clinical trials) and pre-and post-marketing pharmacovigilance (drug safety surveillance and adverse event reporting/SAE reporting). These courses cover pharmaceutical development quality management systems (QMS) and quality risk management (QRM), drug approval processes, […]
Who conducts GMP audits for pharmaceuticals & other therapeutic goods manufacturing?
Who regulates GMP compliance? List of Regulatory Authorities (Regulators) for GMP manufacturing of pharmaceuticals, biologicals, and medical devices. Well-recognized Government Regulatory Agencies around the world include the following agencies/regulatory bodies: Australian Therapeutic Goods Administration (TGA) Malaysian National Pharmaceutical Control Bureau (NPCB) NPCB – Foreign GMP Inspections document Singapore’s Health Sciences Authority (HSA) Singapore’s Therapeutic Products […]
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 […]
Pharmaceutical Water For Injection
What is Water For Injection (WFI)? How does WFI relate to different types of Pharmaceutical Water Quality in pharmaceutical manufacturing settings? And what do engineers and water supply system designers need to know when designing feed-supply water systems, including pre-treatment processes, in PICS GMP regulated manufacturing sectors? These questions are answered in our online training […]
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 […]
Industry Updates: PDA and FDA Joint Regulatory Conference
Our GMP courses, e-learning courses and GMP Forums repeatedly get great reviews by people who need to know the latest PDA and FDA information on regulatory requirements, compliance inspection findings, and GMP compliance audit trends…why is that the case? It’s because our GMP training course experts and quality/risk management compliance consultants regularly attend the top […]