Quality Assurance of Aseptic Preparation Services Standards

Quality Assurance of Aseptic Preparation Services Standards

These 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. We share an aim to develop national standards that support best practice and the care of patients. Pharmacy aseptic preparation services are supporting the care of some of the most critically ill patients.

All the standards have been revised  and updated for this fifth edition.  

The standards are well established and widely used by UK hospital pharmacy departments. Their origin goes back prior to 1993, when the first edition of Quality Assurance of Aseptic Preparation Services was published by the NHS Quality Control Sub-Committee.

The relationship between the Royal Pharmaceutical Society and the NHS Pharmaceutical Quality Assurance Committee extends over many 

years and our publishing division, the Pharmaceutical Press (RPS Publishing), has previously published the third and fourth editions of Quality Assurance of Aseptic Preparation Services. 

Since 2010 the Royal Pharmaceutical Society has become a body akin to a Royal College. As such, it is appropriate for us to produce and host these standards as part of our library of professional standards. The standards have particular relevance to the RPS leadership roles, including our vision for the pharmacy workforce (RPS 2015).

I would like to join the editor, Dr Alison M Beaney, in thanking the contributors. These standards are a result of the hard work and dedication of many experts from across the UK. 

In the UK these nationally agreed quality standards and an audit programme are in place to assure the quality of pharmacy aseptic units (unlicensed) within the NHS. The standards are primarily intended for use within the NHS but they will also be of use to students, licensed units, individuals and organisations in other countries as well as the UK.

Aseptic preparation of medicines is an important part of the service provision by pharmacy departments to facilitate accurate and timely administration  

of injectable medicines for patients.  

It is a complex and demanding activity requiring skilled staff, appropriate facilities and close monitoring  

and control. 

Standards to guide and monitor the safe and accurate delivery of these services have evolved gradually, reflecting the changing expectations and needs for maintaining the high quality of aseptic products in the context of rising workload pressures, often reduced resources, and the increasing complexity of modern medicines. 

The standards contained herein address these issues in a practical way and should assist both those providing these services and those whose role it is to audit them.

Aseptic preparation in the UK is only  exempt from the licensing requirements of the Medicines Act 1968 and subsequent amendments provided all of the following conditions are met 

(MCA 1992): 

 The preparation is done by or under the supervision of a pharmacist, whotakes full responsibility for the quality of the product

The preparation uses closed systems

Licensed sterile medicinal products are used as ingredients or the ingredients are manufactured sterile in licensed facilities

 Products will be allocated a shelf life of no more than one week.The shelf life should be supported by stability data

 All activities should be in accordance with defined NHS guidelines.

The term ‘preparation’ is therefore used to denote activity without 

a manufacturing licence from the Medicines and Healthcare products Regulatory Agency (MHRA), whilst 

‘manufacture’ is used to denote  licensed activity.

The first edition of the Quality Assurance of Aseptic Preparation Services (Quality Control Sub-Committee 1993) gave advice to ensure consistent quality of products prepared in unlicensed hospital aseptic preparation units. It provided the ‘defined National Health Service 

(NHS) guidelines’ required by the then Medicines Control Agency (MCA) in their publication Guidance to the NHS  on the licensing requirements of the Medicines Act 1968 (MCA 1992).  

Updated and expanded versions  

of these guidelines have been  published by the NHS Quality Control/Assurance Committee (Lee 1996, Beaney 2001, Beaney 2006). This new edition has similarly been updated and significantly expanded to provide the NHS with up-to-date standards for aseptic preparation.

Since 2006 there have been significant changes to practice that are reflected in this new edition of the Quality Assurance of Aseptic Preparation Services. The NHS Pharmaceutical Quality Assurance Committee works closely with MHRA to maintain equity of standards between licensed and unlicensed units. Patients treated with products made in the NHS in either of these types of unit are entitled to expect the same level of safety from the products that they receive.

This fifth edition of the Quality Assurance of Aseptic Preparation Services (now published as a standards handbook) includes many new and revised standards in all chapters 

and places greater emphasis on requirements for pharmaceutical quality systems in EU Good Manufacturing Practice (GMP) (EC 2015) and 

for quality risk management (ICH 2005). For example, the scope of the Documentation chapter (Chapter 8) has been expanded to reflect this,  and the chapter has been renamed. This new edition has been reformatted into two parts: Part A – Standards 

(contained in the chapters) and Part B – support resources (contained in what were previously termed appendices). In line with EU GMP (EC 2015) the chapters, although standards, use

‘should’ rather than ‘must’ throughout. All support resources (which are

now published separately) have been revised and updated with the aim

of standardising best practice and providing guidance across the NHS on ways of achieving the standards in the chapters. The information in Part B on Computer Validation, for example, has been used as the basis for an advisory document (PQAC 2015) to assist with, amongst other systems, validation

of electronic prescribing and so is applicable to an expanded audience.

The standards are applicable to all products prepared aseptically in unlicensed NHS units across the UK for administration to patients. Parenteral nutrition solutions, cytotoxic injections, radiopharmaceuticals and additives for parenteral administration are 

the most common examples of such products. As such, the products are of a critical nature and standards for their preparation have a significant impact on patient safety. These standards enable pharmacists supervising unlicensed aseptic activity to implement safe systems of work and to prepare products of appropriate quality.

Executive Letter (97)52 (NHS Executive 1997) introduced a requirement in England for regular external audit of all unlicensed aseptic units by Regional Quality Assurance Specialists to ensure appropriate standards were achieved and maintained. This requirement still applies and similar arrangements are  in place in the other home countries. The standards in the fourth edition 

of the Quality Assurance of Aseptic Preparation Services (Beaney 2006) 

are the basis for this ongoing audit programme at the present time,  

and those in the fifth edition will replace them. 

Although Quality Assurance of Aseptic Preparation Services is primarily used as the basis of the above audit programme 

References across the UK, the text is also used as standards in several other countries worldwide. Additionally, it is used 

for undergraduate and postgraduate pharmacy teaching in academia.

The editor, Alison M Beaney, would like to thank all contributors to this edition for their hard work and dedication in preparing these standards. She would like to acknowledge the helpful comments and suggestions received from members of the NHS Pharmaceutical Quality Assurance Committee, the NHS Pharmaceutical Aseptic Services Group, the UK Radiopharmacy Group, the NHS Technical Specialist Education and Training group, and the Medicines and Healthcare products Regulatory Agency.


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