ICH guideline Q1A(R2), states that “the purpose of stability testing is to provide evidence on […]
Why should I subscribe to GMP trends?
GMP Trends helps you stay up to date on the latest observations being made by the FDA. Read GMP Trends’ relevant, real-time, and unbiased analysis to formulate your quality strategy. Don’t make the same mistakes as other companies; learn from their mistakes.
Facility Inspection Reports
This is a useful tool for auditors to see if vendors or potential vendors are having inspections and what they are being cited for. This is also a useful tool for support businesses (data integrity, cleaning validation, equipment maintenance, stability support, etc.) to see who might benefit from their product by looking at the citations being noted and then marketing to those businesses.
Developed to help you prepare for your next inspection. Be ready at any time.
This template helps you establish a procedure for the creation, approval, storage and distribution of standard operating procedures (SOP).
This Preparation package includes templates and checklists to help you avoid common mistakes when producing your APR.
Our FDA inspection checklist gives the user a description of critical preparatory steps to take in order to be ready for the next time the FDA comes knocking at the door.