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.
GMP Newsletter
Our free publication highlights different examples of recent observations the FDA has made at facilities. GMP Trends gives advice on where to find more information about this topic. Use the newsletter to help improve your systems. Review the documents suggested and check your system. Is everything correct, do you have all the information in your procedures, is your facility following the procedure? Are you making the same mistakes as other facilities?
Bi-Monthly Publication, Annual Report, Special Topics
All of these reports give you insight as to what the FDA is looking for when they come to your facility for inspection.Trainers
Use this information to train your employees on different topics. Show examples of what other facilities are getting cited on. Help ensure your facility is not making the same mistakes.
Auditors (internal audits or vendor audits)
Use these reports to help you determine what you should focus on during your audit. See if your facility or the facility you are auditing is making the same mistakes.
Department Managers
Use the search feature on our website to search topics related to your department. Review errors being made by other facilities. Review the same things in your department. Are you making the same mistakes? Are there additional things you could be doing to enhance your systems and procedures?
Managers / Owners
Review the observations being cited. Determine if you have adequate staff to address similar issues in your facility. Having a robust quality system in place is the best way to mitigate downtime for equipment breakdowns, loss of product due to errors etc.
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.
Free Resources
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.