International GMPs

Self-Inspection

The role of self-inspection is not discussed, or required, in the United States GMPs, however this plays a major role in the European, PIC and WHO GMPs. The European GMPs describe self-inspections in the following way:

“Self inspections should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures. Personnel matters, premises, equipment, documentation, production, quality control, distribution of the medicinal products, arrangements for dealing with complaints and recalls, and self inspection, should be examined at intervals following a pre-arranged programme (sic) in order to verify their conformity with the principles of Quality Assurance. Self inspections should be conducted in an independent and detailed way by designated competent person(s) from the company. Independent audits by external experts may also be useful. All self inspections should be recorded. Reports should contain all the observations made during the inspections and, where applicable, proposals for corrective measures. Statements on the actions subsequently taken should also be recorded.”

While this is deemed in the USA to be the function of internal audit programs, such audit programs are “off limits” to FDA inspectors and are never reviewed for adequacy of self-inspection, or for adequacy of the follow-up actions that might be necessitated from such a self-inspection. Without question, the role of self-inspection is vital to assure final product quality and to attempt to attain continuous improvement in the workplace.



	Introduction

	Drug Quality - Pharmacopoeal Testing

	The Advent of GMPs

	GMPs: Codes, Directives, Guidelines, Points to Consider, or Regulations; and INspection Severity

	Drug Quality – GMP Implementation

	The GMPs

	Quality Management and the Qualified Person

	Validation

	Self Inspection

	Contract Manufacture and Contract Analysis

	Future Trends

	Afterthought

	References