GMP Learning conducts 2 to 3 day audits for regulated industries focusing on industry GMP requirements. The compliance audit will focus on three key control areas which include:       


  2. Buildings
  3. Equipment
  4.  Materials


  2. Policies
  3. Procedures
  4. Records


  2. Employees
  3. Customer Complaints
  4. Vendors/Suppliers


Technical, Operational, and Relational Controls are examined as they relate to key Quality Systems elements outlined by the FDA for a particular industry:


For drug, cosmetic, nutraceuticals and biotech manufacturers the following systems are examined (7356-002 FDA Inspection Program), along with current proposed regulations, guidance documents, compliance programs and rulings related to those industries:

                                    Quality System

                                    Material System

                                    Packaging and Labeling System

                                    Equipment and Facility System

                                    Production System

                                    Laboratory System


For the biotech industry the same systems are examined as with drug manufacturers but also items related to a Team Biologics Inspections are included. For Cosmetics document 7329-003 Domestic Cosmetic Program is also used as a reference.


For medical device manufacturers the following systems are examined (QSIT Systems Approach to Inspection):

                        Quality System

                        Material System

                        Equipment and Facility System

                        Production System

                        Design Controls

                        CAPA System

                        Packaging and Labeling


            For food companies the following elements are examined:

                        HACCP program

                        NFSAN standards

                        AIB Standards

                        Food Title 21CFR Part 110 regulations


At the end of the audit a Findings Summary Meeting will be conducted with management.




A detailed written report will be prepared and mailed to you within two weeks after this audit. The report will include the audit findings and recommendations related to an item action plan to correct any non-compliance issues.