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 […]
FDA Warning Letters – CAPA
FDA Warning Letters for cGMP compliance issues relating to CAPAs If you’re a Pharmaceutical business owner or Quality Manager, you know this all too well — that your deviation management records & CAPA system will be scrutinised during your next GMP compliance audit. Auditors and FDA Inspectors are all but guaranteed to delve deeply into […]
GMP Education Topics: Induction Bundles
Did you know you can mix and match GMP education topics when ordering online GMP training courses? You can purchase courses individually or in bulk, depending on your needs. Options for bundles include a discounted pack of any 4 standard courses, a 6-bundle package, an 8-bundle package, a 20 bundle package, and more! The benefit […]
New employee training needs (employee and public safety)
New training trends continue to emerge since Covid-19 was first recognised as a global threat. The 2021 Australian Employer Survey report from NCVER (regarding ASQA/VET skills training courses) was released in October 2021. The survey indicates that Employers experienced an increased need for new employee training programs since the pandemic began. This is not surprising, […]
Online Learning During the Pandemic
Online learning during the pandemic – a practical solution to GMP training requirements. The education industry was particularly impacted by Covid-19; and by the 2nd quarter of 2020, most face-to-face training sessions were put temporarily on hold. Temporarily on hold turned to indefinitely on hold; as the pandemic continued to wreak havoc around the globe. […]
What is a GMP Inspection?
GMP inspection (Definition) A GMP inspection (‘GMP compliance audit’) will generally involve an onsite visit by a specially-trained Inspector/Auditor; who examines various components of the manufacturer’s Pharmaceutical Quality System (PQS). The GMP inspection generally includes, but is not limited to, reviews of manufacturing procedures (SOPs) across the product lifecycle, supplier qualification procedures, facilities and equipment […]
Non-medical use (NMU) of Pharmaceuticals (Diversions)
Non-medical use (NMU) of prescription medications, polysubstance use, and criminal product diversions are contributing to overdose incidents and drug-induced deaths. We’d like to bring your attention to International Overdose Awareness Day, held annually on the 31st of August, and to the risks of non-medical use of prescription medications. Concurrent drug use is common, and it […]
Training Credentials – Training Course Badges
Training Credentials and GMP Training Certificates: GMP Training Course Badges Finishing a well-recognised qualification from a notable education provider doesn’t mean you actually understand what it’s really like to work in a particular industry. Certainly, in the life science sector, a University degree is one of the more imperative training credentials you will need to […]
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 […]
Pharmaceutical Industry Jobs: 5 Essential Skills
What are the requirements for applying for pharmaceutical industry jobs? Are you applying for current Pharmaceutical industry job openings? If yes, there are 5 essential skills you’ll need to develop to be successful in your employment. The pharmaceutical sector includes medical device manufacturing, biologic medicines, veterinary medicines, medicinal cannabis cultivation and production, and certain nutritional supplements and […]