International GMPs

Contract Manufacture and Contract Analysis

The European and International GMP codes (PIC and WHO) have extensive sections regarding the roles and responsibilities of contract giver and contract receiver when pharmaceutical manufacturers sub-contract either parts of the manufacture or the testing of the pharmaceutical product.

It is FDA’s position that whether a company manufactures/tests a product itself, or whether it contracts this activity out to others, such a decision is purely an economical one – the manufacturer’s decision to make in-house or contract-out being purely dependant on which option is the best business decision. As such, although there is no specific GMP regulation per se, FDA holds the manufacturer responsible for all aspects of GMP non-compliance by the contractor. This onus is taken to extensive lengths as witnessed by a warning letter issued by FDA in 2002 that held a pharmaceutical manufacturer liable for GMP non-compliance of its contracted software company. The GMP non-compliance was that the software company had not provided GMP training to its software programmers – a basic GMP requirement stated in the GMP regulations.



	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