Procedure for assessing the acceptability, in principle, of vaccines ...

validation. In case of contract manufacturing and contract testing of part of the
process, provide information on the way in which GMP compliance of the contract
acceptor is assessed.
1.6 Give a short description of the quality management system of the company
responsible for manufacture.
1.7 Give a short description of the internal audit system and the programme for
qualifying suppliers of raw materials.
1.8 List manufacturers supplying biological raw materials and adjuvants
Chapter 2: Personnel
2.1 Provide an organizational chart showing the relationships between different areas,
including quality assurance, production and quality control, with identification by
name of key personnel (heads of production, quality assurance, quality control,
warehousing and engineering).
2.2 Provide curricula vitae for heads of production, quality assurance and quality
control, indicating educational and experience qualifications.
2.3 Outline arrangements for basic and continuing training and how records are
maintained.
2.4 Describe requirements for personnel engaged in production, particularly relating
to requirements for monitoring of health status (including immune status) of
production personnel, and for outside contract service personnel entering the
manufacturing areas.
Chapter 3: Premises and equipment
These will be examined in depth during the site audit. However, the following
preliminary information must be submitted:
3.1 Provide simple, currently valid, floor plans and text descriptions of manufacturing
and quality control areas. The floor plans should give an indication of scale, air flow
and flows of materials, product, personnel and waste (architectural or engineering
drawings are not required), room classification, and air handling unit identification by
room.
3.2 Describe the nature of construction and finishes of manufacturing and quality
control areas.
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