Quality Assurance Of Aseptic Preparation Services Pdf

[Emerson Mata]

Thisguidance sets out the governance and regulatory arrangements for aseptic preparation of medicines for NHS patients in England and replaces the 1997 NHS Executive letter EL(97)52, Aseptic dispensing in NHS hospitals.

It also describes the oversight provided by the Care Quality Commission (CQC) and the inter-relationships between the regulatory bodies, primarily the CQC, Medicines and Healthcare products Regulatory Agency (MHRA) and General Pharmaceutical Council (GPhC).

This guidance addresses the above recommendation, is consistent with the current NHS infrastructure and replaces EL(97)52 in England with immediate effect. It applies to provision of all aseptically prepared medicinal products within NHS pharmacy aseptic facilities, other than those products manufactured under an MHRA MS authorisation (see Scope of guidance section below).

Most such services operate under Section 10 exemption from the Medicines Act 1968 (as referenced in The Human Medicines Regulations 2012), but as detailed below, the scope of this guidance also encompasses a range of aseptic activities that sit outside the Section 10 exemption and outside the scope of MHRA MS authorisation. These include, for example, aseptic preparation/reconstitution of investigational medicinal products (IMPs) and advanced therapy medicinal products (ATMPs) within NHS pharmacy aseptic facilities in England.

This guidance specifies the process for auditing, monitoring, assuring and reporting compliance of services and facilities with critical quality and patient safety parameters, and for responding to serious concerns about non-compliance. It also specifies the process for escalation of unresolved concerns and signposts to other key guidance and standards applicable to NHS aseptic preparation services and activities.

The guidance is predicated on universal implementation of a template for a digital, good manufacturing practice (GMP) based audit and compliance management system termed iQAAPS (interactive quality assurance of aseptic preparation services). This is supported by a web-based process that enables trust chief pharmacists to develop and improve their services (see Revised assessment process section and Appendix 1 for further details).

This guidance has been developed for NHS England by a short life working group (see Appendix 5). It will be formally reviewed no later than month/+ three years from the date of publication, or sooner in the event of any significant change.

The principles and processes described in this guidance apply to all aseptic preparation of medicinal products in NHS pharmacy aseptic facilities in England, other than those products manufactured under an MHRA authorisation. The guidance therefore applies to all NHS pharmacy aseptic facilities in England undertaking preparation of sterile medicinal products under Section 10 exemption to the Medicines Act 1968 (as amended), even when provided from facilities that concurrently hold an MHRA MS authorisation.

Overarching organisational responsibilities for NHS organisations performing aseptic preparation, SPS QA, NHS England and the CQC are specified below. Requirements for key individuals and services, and the roles of primary stakeholders are documented in Appendix 3.

SPS QA officers with suitable knowledge and experience in aseptic preparation and quality assurance perform these audits. The specialists are the lead regional quality assurance pharmacists in their local area or trained and nominated auditors accountable to the lead regional QA pharmacist. Audit teams cover each of the NHS regions in England and report to the Head of SPS for England via the SPS QA hub lead. Each audit team maintains a local list of sites to be audited, including details of aseptic services provided, and sets the local audit programme.

iQAAPS is a digital, GMP-based audit and compliance management system implemented to manage a number of activities linked to the audit process and provide greater oversight of aseptic preparation. Specifically it:

In addition, a self-assessment function enables aseptic facilities to self-declare their compliance with the QAAPS standard. Evidence statements can be created to support the self-assessment rating. Action plans can also be produced in response to internal audit findings to drive quality improvement.

Each facility is responsible for reporting a set of predefined quality indicators to NHS England via the iQAAPS system on a monthly basis. These are liable to evolve over time; the QIs in place at the time this guidance is published are detailed in Appendix 4.

Note: Failure to submit QIs or to take appropriate action in response to results may impact on the re-audit frequency of the site or escalation in accordance with the Compliance management and escalation section of this guidance.

Compliance management is automatically triggered for every service that is identified as having a high risk rating, and also for any site identified as having a medium risk rating that is failing to make adequate progress with corrective and preventive actions, submit QIs or for which the QI data demonstrates a loss of control.

Services placed under stage 1 enhanced oversight or stage 2 escalation may appeal the decision. The trust chief pharmacist must make any appeal in writing to the head of SPS; this must detail any concerns being raised, provide evidence to support the appeal and must be countersigned by the trust chief executive.

Provider collaboratives, integrated care system (ICS) and NHS England regional teams should appropriately resource pharmacy quality assurance services in their respective areas. This resourcing should be used to develop teams of individuals with the relevant expertise to assist underperforming units (as identified through auditing with the iQAAPS system), applying corrective and preventive actions as appropriate. These teams should also develop and deliver training materials for aseptic services across the area to ensure workforces are kept suitably up to date on current practices.

SPS QA produces a quarterly national situation report to provide an overview of the status of all NHS pharmacy aseptic facilities in England. Reports are distributed to the NHS England Chief Pharmaceutical Officer, Head of SPS and Head of the NHS Infusion and Specials Medicine Programme.

SPS QA produces a quarterly regional situation report to provide an overview of the status of all NHS pharmacy aseptic facilities in the appropriate NHS region. Reports are distributed to all NHS England regional chief pharmacists.

SPS QA produces site-specific compliance management reports for all sites placed in stage 1 enhanced oversight and stage 2 escalation. Updates to the report are produced monthly. The reports are distributed to the NHS England Chief Pharmaceutical Officer, Head of SPS, Head of the NHS Infusion and Specials Medicine Programme, regional chief pharmacist, trust chief executive and trust chief pharmacist. Reports are shared with other regulators on request.

Manufacture includes any process carried out in the course of making a medicinal product but specifically excludes dissolving or dispersing the product in, or diluting or mixing it with, some other substance used as a vehicle for the purposes of administering it.

Aseptic preparation is the reconstitution of an injectable medicine or any other aseptic manipulation when undertaken within NHS aseptic facilities to produce a labelled ready-to-administer presentation of a medicine, in accordance with a prescription provided by a practitioner, for a specific patient.

Although reconstitution may be performed in a clinical area or within a pharmacy aseptic unit, it is classed as a preparation activity within the scope of this guidance when it is performed in the latter.

In the context of investigational medicinal products, Regulation 37 of the Medicines for Human Use (Clinical Trials) Regulations 2004 provides an exemption for hospitals and health centres to allow labelling activity to be undertaken by a person operating under the supervision of a pharmacist.

See Roles and responsibilities section for overarching organisational responsibilities for NHS organisations performing aseptic preparation, Specialist Pharmacy Service Quality Assurance (SPS QA) and NHS England.

The new guidance makes explicit not only the audit process, but the process for escalation of concerns and accountability for that. The aseptic preparation of medicines is widely recognised to be an area of high risk NHS work and the focus is assuring the quality of this work.

The guidance describes the inter-relationships with the regulatory bodies, primarily the Medicines and Healthcare products Regulatory Agency (MHRA), Care Quality Commission (CQC) and General Pharmaceutical Council (GPhC). It also defines the roles and responsibilities for the following groups in meeting the stated requirements.

The NHS England Specialist Pharmacy Service Quality Assurance service (SPS QA) have a role in providing regulatory oversight and inspection of aseptic preparation activity, and auditing services against quality standards.

The ability of NHS organisations to meet the necessary standards is predicated on universal implementation of a template for a digital, Good Manufacturing Practice (GMP) based audit and compliance management system termed iQAAPS (interactive Quality Assurance of Aseptic Preparation Services), which is being rolled out by SPS. This is supported by a web-based process which enables Chief Pharmacists to develop and improve their services.

The majority of the services operate under Section 10 exemption from the Medicines Act, but as detailed below, the scope of the guidance also encompasses a range of aseptic activities that sit outside Section 10 exemption and outside the scope of MHRA MS Authorisation. These include, for example, aseptic preparation / reconstitution of Investigational Medicinal Products (IMPs) and Advanced Therapy Medicinal Products (ATMPs) within NHS pharmacy aseptic facilities in England.

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