Good Manufacturing Practice (cGMP) Audits

The interpretation and application of current Good Manufacturing Practice (cGMP) is critically important in order to meet the expectations and requirements of your customers as well as the US Food and Drug Administration (FDA).

cGMPs require that manufacturers, processors, and packagers of drugs, medical devices, food, and blood take proactive steps to ensure that their products are safe, pure, and effective.

GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling

·    GMP – Good Manufacturing Practice –

o   US Parts 210/211 and Predicate Rules. 

o   EU Good Manufacturing Practice Audits,

o   Canadian GMPs,

o   Facility Audits,

o   Mock FDA Audits,

o   Department and Internal Systems,

o   Vendors and Suppliers,

o   Documentation audits,

o   ‘For-cause’ – ‘Due Diligence’ audits. 

o   Standard Operating Procedures,

o   Validation and

o   Compliance Audits.

o   Good Documentation Practice Audits

o   Good Auditing Practices

o   Quality Assurance / Quality Control Audits

o   CAPA, Recall and Complaint Systems