Are you Ready for GMP Certification?

Ensuring Quality and Compliance in Manufacturing
Good Manufacturing Practice Certified badge

Take the GMP Readiness Questionnaire

Industry: (select all that apply)

For questions 1 - 13, select the option that best describes your current state

A. Yes – We have a fully established process that is written, approved, and followed consistently.

B. Somewhat – We have a process, but it needs improvement, approval, or is inconsistently followed.

C. No – We do not have this process in place.

1. Do you have a Quality Manual that describes your company’s product, quality objectives, and regulations you adhere to? *
2. Do you conduct and document management reviews for deviations, CAPAs, complaints, audits, trainings, change controls, and supplier performance? *
3. Do you have a Good Documentation Practices (GDP) procedure that includes record retention requirements? *
4. Do you have a Training Program that outlines training expectations for all roles within the company? *
5. Do you conduct and document annual GMP Training for all staff? *
6. Do you have a supplier approval procedure, and are all suppliers documented in the approved suppliers list? *
7. Do you have documented procedures for inspecting and testing incoming materials and finished product? *
8. Do you have defined procedures for manufacturing, maintenance and calibration? *
9. Do you have approved Batch Records that are completed, reviewed, and dispositioned for each batch you produce? *
10. Do you have a Change Control Policy? *
11. Do you document, investigate, and disposition all complaints and deviations? *
12. Do you perform internal audits on a predetermined schedule? *
13. Do you have a procedure for product holds and recalls? *

Take the GMP Readiness Questionnaire

Industry: (select all that apply)

For questions 1 - 13, select the option that best describes your current state

A. Yes – We have a fully established process that is written, approved, and followed consistently.

B. Somewhat – We have a process, but it needs improvement, approval, or is inconsistently followed.

C. No – We do not have this process in place.

1. Do you have a Quality Manual that describes your company’s product, quality objectives, and regulations you adhere to? *
2. Do you conduct and document management reviews for deviations, CAPAs, complaints, audits, trainings, change controls, and supplier performance? *
3. Do you have a Good Documentation Practices (GDP) procedure that includes record retention requirements? *
4. Do you have a Training Program that outlines training expectations for all roles within the company? *
5. Do you conduct and document annual GMP Training for all staff? *
6. Do you have a supplier approval procedure, and are all suppliers documented in the approved suppliers list? *
7. Do you have documented procedures for inspecting and testing incoming materials and finished product? *
8. Do you have defined procedures for manufacturing, maintenance and calibration? *
9. Do you have approved Batch Records that are completed, reviewed, and dispositioned for each batch you produce? *
10. Do you have a Change Control Policy? *
11. Do you document, investigate, and disposition all complaints and deviations? *
12. Do you perform internal audits on a predetermined schedule? *
13. Do you have a procedure for product holds and recalls? *

Latest News