A Practical Guide to FDA Warning Letter Remediation
An FDA Warning letter is an official document that is sent by the U.S. Food and Drug Administration in case there are major regulatory non-compliances identified. These shortcomings tend to reflect the existence of severe gaps in Current Good Manufacturing Practices (cGMP) that can affect the quality of products or data integrity or safety of patients. It is also imperative to implement prompt and effective remedies to reinstate compliance and defence of the regulatory position of an organization.
A Basic Guide to Good Manufacturing Practice (GMP) Audit and Checklists
Good Manufacturing Practice (GMP) is a system to ensure constant production and control of products in accordance with quality standards. A Good Manufacturing Practice (GMP) audit is a structured investigation or evaluation of a facility, processes, and documentation at a manufacturing site. Audits are very important and can be applied in such industries as pharmaceuticals, medical devices, food, cosmetics, and chemicals, where the safety and consistency of products are indispensable.
What is Eco-Pharmacovigilance?
Eco-Pharmacovigilance (EPV) is the group of science and activity that is related to identifying, measuring, comprehending, and avoiding the negative impact of pharmaceutical substances on the environment. It is concerned with the detection of risks of medicinal products as soon as they get into the ecosystems either through human actions, through manufacturing processes or inadequate disposal.
What is Environmental Risk Assessment (ERA)?
Environmental Risk Assessment (ERA) is a process applied to the identification, assessment, and control of the risks associated with the environment that are caused by human activity or natural occurrence. It can assist organizations to know the effects that their operations can have on the air, water, soil, ecosystems, and the health of humans so that they can make informed decisions and develop sustainably.
What is a Finished Dosage Form?
A Finished Dosage Form (FDF) refers to a pharmaceutical product that has gone through all stages of manufacture, processing, packaging, and labeling and is ready for distribution and administration to a patient. An FDF contains an active pharmaceutical ingredient (API) along with excipients in a predetermined form that is safe, of quality, and medically efficacious.