Paragraph 21 F1
A description of the arrangements for maintaining—
(a)
production records, including records of manufacture and assembly;
(b)
records of analytical and other tests used in the course of manufacture or assembly for ensuring compliance of materials use in manufacture, or of active substances, with the specification for such materials or active substances;
(c)
records of importation;
(d)
records of storage and distribution.
Annotations
Textual amendments
- F1
Sch. 7A inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 33