Blog

Sep
16

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. […]

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Sep
06

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 […]

By Connie May | Uncategorized
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Aug
17

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 […]

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Jul
21

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 […]

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Jun
18

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 […]

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May
27

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 […]

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May
17

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 […]

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Apr
12

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 […]

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Mar
12

Best Practice Online Assessments: Top 5 Tips

Demand for best practice online assessments increased rapidly ever since the education sector had to react to the impacts of a global pandemic. By the year 2021, it became clear that online training — and online assessments — are here to stay. While Covid lock-downs and travel restrictions had a devastating impact on a wide […]

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Feb
02

Zoom etiquette: virtual training delivery

ZOOM etiquette and Zoom Meeting DO’s and DON’TS made all the top 10 blog topics lists (2020-2021). In 2021, Zoom etiquette continues to be a dominant blog theme. These virtual meeting platforms are here to stay, especially with travel restrictions likely to continue for at least the next two (2) years (or longer). As the […]

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Jan
20

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 […]

By Connie May | GMP Audits . Medical Device (SaMD)
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Dec
21

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 […]

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