Quality Manuals/SOP’s/Briefing Binders

• Need help with writing your Quality Manual/Plan?

 GMP Learning can help. We have worked with numerous companies

 helping them develop their own Quality Manual or Quality Plan utilizing a generic version of a robust Quality Manual that the GMP Learning Center has developed as a guide to ensure that all elements of your Quality System are covered in your plan.

• Need help with writing your regulatory required Quality SOP’s?

 GMP Learning experts, utilizing a designed and developed framework tool, can help you to identify the procedures and work instructions that you need to   have in place from a regulatory and performance perspective.  The framework is divided into 9 key compliance sections with each section containing numerous  subsections.

The main categories of the framework are as follows:

Quality System Framework

                        Section 1          General Quality System Controls

                        Section 2          Document Control

                        Section 3          Facility Controls

                        Section 4          Equipment Controls

                        Section 5          Material Controls

                        Section 6           Production Controls

                        Section 7           Labeling Controls

                        Section 8          Packaging Controls

                        Section 9          Laboratory Controls

Once you see the subsections under each section and the regulatory references (device and drug industry) for each subsection to the CFR/GMP/QSR requirement, you will understand how this approach makes it nearly impossible to not have a procedure required by the GMP/QSR requirements. This helps ensure regulatory compliance from a procedural perspective.

Once the Framework is instituted, we work with you to find the gaps in your current procedural and record keeping system and work together via proven effective procedure writing techniques to fill those gaps. 

• Need help with your Master SOP?

      Yes, we can help you with that also. Give our experts a call.

• Need help with an FDA Briefing Binder to ensure you are proactively prepared for a visit from the FDA?

 GMP Learning has worked with many companies to assemble a briefing binder that help expedite the FDA inspection and demonstrates proactiveness on the part of your company when hosting an inspection. This is also a good practice and a helpful tool for visits from OSHA, EPA, USDA, or any regulatory agency, not just the FDA.

Let GMP Learning help you today!