COMPLIANCE AUDITS
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:
- TECHNICAL CONTROLS
- Buildings
- Equipment
- Materials
- OPERATIONAL CONTROLS
- Policies
- Procedures
- Records
- RELATIONAL CONTROLS
- Employees
- Customer Complaints
- 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.
DELIVERABLE:
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.