Corrective and Preventive Action (CAPA) is a key process within a pharmaceutical quality management system. It is the process of identifying and documenting corrections and improvements to systems and processes to reduce the risk of a deviation, non-conformance or …
Data integrity continues to be a focus during US FDA inspections. A number of warning letters issued by the FDA in 2022 highlight the importance of Data Integrity compliance.
In the warning letters issued, the FDA references the FDA’s guidance …
FDA Citation Tracking Tool Updated October 2022
I’m excited to share that QikSolve has helped us to update track and trend all the FDA inspection 483 citations from 20011 to 2021, the tool dynamically scrapes data from various live websites …
This popular blog has been updated in 2022 with the latest FDA data.
As we all know there has been an increasing regulatory emphasis on the importance of Quality Metrics. Where there is a demand, there will also follow a …
Certain medical devices utilize animal materials in their manufacture to provide performance characteristics that are more advantageous than non-animal-based materials.
The use of animal material, however, carries the risk of transmitting infectious diseases when it is improperly collected, stored or …
What is a Unique Device Identifier (UDI)?
Unique Device Identifier (UDI) is a globally unique series of characters for each medical device on the market to:
Unambiguously identify a device for patient safety
Improve medical device traceability in the supply chains
The Unique …
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 …
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 …
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 …
FDA Crackdowns on False Claims for Medicinal Cannabis Products
False Claims, Fake Medicines and Counterfeit News – Why the U.S. FDA is cracking down on cannabis-product advertising claims and unsubstantiated efficacy statements.
Are U.S. medicinal cannabis suppliers preying on vulnerable populations …
