SCHEDULE 1STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE RELATING TO THE MANUFACTURE AND ASSEMBLY OF RELEVANT MEDICINAL PRODUCTS
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The licence holder shall keep readily available for examination by a person authorised by the licensing authority durable records of the details of manufacture of any intermediate products held by him which are for use in the manufacture of biological medicinal products for human use, and these records shall—
a
be in such form as to ensure that the licence holder has a comprehensive record of all matters that are relevant to an evaluation of the safety, quality and efficacy of any finished biological medicinal product for human use which he manufactures using those intermediate products; and
b
not be destroyed without the consent of the licensing authority until the records of the details of manufacture of any finished medicinal products which were or may be manufactured using those intermediate products may be destroyed in accordance with the requirements of these Regulations.