Audit Deficiencies – How does your organisation compare with others?
| |

Audit Deficiencies – How does your organisation compare with others?

Have you ever come away from an audit feeling unsure of your own organisational processes? Do you sometimes feel that your organisation is alone or unique in the types of audit deficiencies observed? How do you compare with others with respect to audit deficiencies? Audit Deficiencies Reported by the TGA The Australian Therapeutic Goods Administration…

What is GxP compliance?
| | | |

What is GxP compliance?

Industry support of overdose prevention This is blog 8 of 10 Blogs in the overdose awareness and overdose prevention series. What is GxP compliance? And how does GMP/GxP compliance help with overdose prevention efforts? GMP and GxP are pharmaceutical-industry quality standards and manufacturing guidelines. These quality standards apply to the manufacture of pharmaceutical products, medical devices,…

Opioid Crisis (Legal Cases)
|

Opioid Crisis (Legal Cases)

Snapshot of the Opioid Crisis (Legal Cases) This is blog 6 of 10 blogs in the overdose awareness and overdose prevention series. International Overdose Awareness Day (31st August) is rapidly approaching. It warrants a discussion of the opioid crisis in the United States, a 20-year phenomenon where over 800,000 people have lost their lives to…

Impact of COVID-19 on Pharmaceutical Manufacturing
|

Impact of COVID-19 on Pharmaceutical Manufacturing

How is the pharmaceutical manufacturing industry around the world expected to continue production during the COVID-19 pandemic? What control measures should be in place to help prevent or mitigate the potential adverse effects of COVID-19 on the safety and quality of products? In April 2020, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published…