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Regulations for NHS aseptic services

Published
Topics: Aseptic services

NHS pharmacy aseptic services are tightly regulated to maintain high standards and ensure patient safety.

This article forms part of a series
  1. Understanding aseptic services in the NHS
    1. Introduction to aseptic manipulation of injectable medicines
    2. Assuring quality in NHS aseptic services
    3. Regulations for NHS aseptic services

Contents

  1. Understanding why regulation is important
  2. MS licence
  3. Section 10 exemption
    1. Assurance of aseptic preparation of medicines guidance
    2. Quality Assurance of Aseptic Preparation Services (QAAPS)
  5. Being audited and inspected

Understanding why regulation is important

Aseptic services are highly regulated because of the significant risks to patient safety from error and microbial contamination. The risks are explained in the other articles in this series.

This article explains the two different ways pharmacy aseptic services are regulated:

  • a Medicines and Healthcare products Regulatory Agency (MHRA) Manufacturing Specials authorisation, commonly referred to as an MS licence
  • Section 10 exemption from the Medicines Act 1968 (via Regulation 4 of Human Medicine Regulation 2012)

MS licence

An MS licence provides the highest level of quality assurance for ensuring aseptically made medicines are safe and effective. An MS licence can cover all categories of manufacturing activities, from patient specific doses to large-scale manufacturing, but is essential for units manufacturing medicines as batches or for stock.

All MS licence holders have a person responsible for quality control and a person responsible for production, both of whom are named on the licence.

MS licensed units are required to comply with Good Manufacturing Practice (GMP) and follow the MHRA’s guidance for ‘specials’ manufacturers. These services are subject to MHRA GMP inspections at a risk-based frequency determined by the inspector. Interim compliance reports should be submitted following any significant change between inspections or as requested by the inspector.

Section 10 exemption

Section 10 exemption of the Medicines Act allows medicines to be prepared without the need for an MS licence provided all of the following conditions are met:

  • The medicinal product is prepared by or under the supervision of a pharmacist in a registered pharmacy, a hospital, a care home service or a health centre.
  • In accordance with a medical prescription given by a practitioner.
  • For a specific patient.

When working under Section 10 exemption, additional restrictions are required, compared to working under a MS licence. These are detailed in NHS England’s guidance on assurance of aseptic preparation of medicines.

Section 10 preparation falls under the regulatory oversight of the General Pharmaceutical Council (GPhC) for registered premises, or the Care Quality Commission (CQC) for unregistered premises, rather than the MHRA.

The Specialist Pharmacy Service Quality Assurance team is commissioned to undertake risk-based audits of these services at a maximum frequency of 24 months.

Assurance of aseptic preparation of medicines guidance

In March 2023, NHSE published guidance on the Assurance of aseptic preparation of medicines. This document sets out the governance and regulatory arrangements for the aseptic preparation of medicines for NHS patients in England and replaces the 1997 NHS Executive letter EL(97)52, Aseptic dispensing in NHS hospitals.

The guidance provides comprehensive information on

  • the scope of guidance
  • restrictions for aseptic preparation
  • roles and responsibilities of NHS organisations and regulators
  • the assessment process and audit arrangements, including the application of the Interactive Quality Assurance of Aseptic Preparation Services (iQAAPS) system
  • assurance and performance management arrangements
  • compliance management, escalation and improvement processes
  • reporting arrangements

Quality Assurance of Aseptic Preparation Services (QAAPS)

The QAAPS professional standards for the quality assurance of aseptic preparation services are a joint initiative between the Royal Pharmaceutical Society and the NHS Pharmaceutical Quality Assurance Committee.
QAAPS provides a nationally recognised minimum standard for quality, safety and governance. It supports both regulatory compliance and continuous improvement covering key areas such as

  • clinical interface
  • management and infrastructure
  • production
  • quality control

Compliance with the standard ensures that aseptic services are robust, patient-focused, and fit for purpose.

iQAAPS is a web browser-based system to support SPSQA oversight and external audit of NHS Section 10 pharmacy aseptic preparation. Understanding iQAAPS (SPS page) provides more information.

Being audited and inspected

The article on preparing for audits and inspections of aseptic services (SPS page) provides further advice on the experience of being audited either by the SPS QA service or by the MHRA inspectorate.