Paragraph 13 AuditF1

(1)

Risk-based audits of the quality system must be performed at regular intervals to ensure that the quality system complies with the quality system requirements set out in paragraphs 8, 10, 11 and 12, and to determine its effectiveness.

(2)

The audits referred to in sub-paragraph (1) must be conducted by individuals who have no direct involvement in or responsibility for the matters or processes being audited.

(3)

Following a risk-based audit—

(a)

any corrective action, including a follow-up audit of deficiencies, must be taken where necessary;

(b)

a report on the results of the audit must be drawn up for each audit and follow-up audit;

(c)

the audit report must be sent to the management responsible for the matters audited; and

(d)

the dates and results of audits and follow-up audits must be documented in accordance with regulation 184(1)(b).

Annotations

Textual amendments

F1: Sch. 12A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 6 (as amended by S.I. 2019/1385, reg. 1, Sch. 1 para. 9 and S.I. 2020/1488, reg. 1, Sch. 2 para. 192); 2020 c. 1, Sch. 5 para. 1(1)