Paragraph 7
Unless the licensing authority otherwise direct in writing, the licence holder shall ensure that any medicinal product which is for parenteral administration satisfies the following tests—
sterility,
abnormal toxicity, and
pyrogens (except in the case of vaccines and preparations of insulin).
Where the licensing authority has directed that the provisions of the preceding sub-paragraph need not apply, the licence holder shall either—
ensure that the medicinal product as aforesaid has satisfied the said tests, or
satisfy himself, taking into consideration—
the in-process controls carried out during the manufacture of the medicinal product as aforesaid, and
the results obtained from testing in accordance with sub-paragraph (1) above other batches of medicinal products of the same description,
that if tested in accordance with sub-paragraph (1) above, the medicinal product as aforesaid would satisfy the said tests.
The tests referred to in sub-paragraph (1)(a), (b) and (c) above shall be—
the tests set out in Parts II, III and IV respectively of this Schedule, or
where the medicinal product as aforesaid is one in respect of which there is a monograph in the European Pharmacopoeia, the tests specified in the European Pharmacopoeia, or
such other tests as the licensing authority may in any particular case approve.
The said tests shall be made after every manufacturing process has been completed unless the licence holder has obtained the consent of the licensing authority in writing to testing at an earlier stage in the manufacture.
The licence holder shall keep readily available for inspection by a person authorised by the licensing authority durable records of all the relevant details of the said tests including records of the examination of each tube, vessel or animal as the case may be and shall ensure that the said records are not destroyed for a period ending six months after the expiry date has passed.