This article considers regulatory guidance on airflow velocities and the way that these are verified, and whether satisfactory airflow can be achieved outside of these guidance values.
The training quality system is a critical component of the site quality program in pharmaceutical, medical device, and other regulated industries.
Let's delve into actual work experiences – problems and solutions to problems that may be helpful to other compliance professionals.
The author's reflections over any years of performing GMP audits worldwide in which there have been many occasions of animal issues in pharmaceutical or in active pharmaceutical ingredient (API) manufacturing. Read what he learned.
The investigation of out-of-specification (OOS) results is an important part of the work undertaken by the analytical laboratory. The OOS process is concerned with the examination of any result that falls outside established acceptance criteria.
Test methods and specifications are integral parts of stability testing for combination products and play important roles in the success of a stability program. Combination medical devices have special considerations due to the complexity of the device design and integration of drug components.
This paper is a preparation for the types of concern that may arise in an inspection, in which microbiologists normally face. In addition, verify that your site has all the necessary documents in place.