These processes shall be managed by the manufacturer in accordance with the requireme ...

3.13 Quality audit means a systematic, independent examination of a manufacturer's qu ...

Improvement General: The manufacturer shall identify and implement any changes necess ...

Appendix I CONTENTS OF A SITE OR PLANT MASTER FILE The manufacturer shall prepare a s ...

(d) records needed to provide evidence that the realisation processes and resulting p ...

(d) records needed to provide evidence that the realisation processes and resulting p ...

(e) all personnel shall bear clean body covering appropriate to their duties. Smoking ...

Purchasing information shall describe the product to be purchased, including where ap ...