Pharmaceutical quality, regulatory affairs, and CMO oversight professionals
A strong clinical package is not enough. This week’s inspection and audit news is a reminder that m…
A strong clinical package is not enough. This week’s inspection and audit news is a reminder that m…
TCI Co., Ltd BioCosme PABP BRANCH, based in Taiwan, received an FDA Warning Letter dated 2 Septembe…
**Company:** Bausch & Lomb Inc. **Country:** United States (Tampa, Florida facility) **Audi…
The World Health Organization has released a draft guidance on Quality Risk Management (QRM) design…
Global inspection activity is sending a consistent message. Authorities are still willing to accept…
ISO 9001:2015 Clause 6.1.1 – Actions to Address Risks and Opportunities: Consider Risks and Opportu…
Standard Operating Procedure (SOP) Clause 6.2 – Quality Objectives and Planning to Achieve Them ISO…
Clause 6 – Planning of ISO 9001:2015 ensures that the organization plans its Quality Management Sys…
Clause 5.3 - Leadership by Defined Roles & Responsibilities Standard Operating Procedure (SOP) …
Clause 5.2 – Quality Policy of ISO 9001:2015 requires top management to establish, implement, maint…