Fundamentals
Key information about aseptic services.
- Understanding aseptic services in the NHS
- Assuring quality in NHS aseptic services
- Regulations for NHS aseptic services
- Introduction to aseptic manipulation of injectable medicines
Pharmaceutical quality systems
Guidance on developing pharmaceutical quality systems (PQS).
Contamination control
Our guidance on controlling contamination in aseptic services.
- Understanding contamination control in pharmacy aseptic services
- Process risk assessments for a Contamination Control Strategy
- Aseptic transfer processes using sporicides
Aseptic processing
Our guidance on making unlicensed medicines in aseptic services.
- Preparing eye drops in unlicensed aseptic units
- Vial Sharing in Aseptic Services
- Restricted to NHS: Managing particulate contamination of aseptic medicines
- Making unlicensed medicines
Stability
All our resources and guidance on stability and assigning shelf lives for aseptically prepared medicines.
Guidance
- Restricted to NHS: Stability resources for aseptic services
- Shelf lives of aseptically prepared medicines in NRFit syringes
- Deriving and assessing stability data for medicines
Stability tool
Access our Stability Information for Aseptics Tool (available only for NHS registered users).
Our stability monographs support the understanding of drug stability and help users to make an informed decision of the shelf life for products prepared within aseptic facilities.
Validation
Guidance to support facility, equipment and process validation.
- Validation master plans
- Computer Systems Validation
- Integrity of syringes for aseptically made medicines
Audit
Our guidance on self-inspection and being audited, including use of the Interactive Quality Assurance of Aseptic Preparation Services (iQAAPS) system.
- Preparing for audits and inspections of aseptic services
- Understanding iQAAPS
- Submitting iQAAPS Quality Indicators (QIs)
Management
Resources for managers and chief pharmacists.
- Understanding aseptic services in the NHS
- Design, build and maintenance of pharmacy aseptic units
- Managing an intrathecal chemotherapy service
- Supply of aseptically prepared IMPs across legal boundaries
Workforce
Information to support workforce planning in aseptic services.
- Accredited training for pharmacy staff within technical services
- Supervision of aseptic preparation under Section 10 exemption
- Northern Pharmacy Technical Services Workforce Project Report
Quality control
Guidance on quality control testing in aseptic services.
- Detecting HEPA filter leaks using dispersed oil particle aerosols
- Quality Control chemical testing of aseptically prepared products
- Integrity of syringes for aseptically made medicines
- Validation of quality control analytical methods
Videos
SPS videos based on emerging themes and problem areas identified at aseptic preparation audits and from queries from Trusts
Next SPS Quality Assurance (QA) events
Bite-size learning events presented by the SPS QA team, and other events for Pharmacy Technical Services.
NHS Pharmaceutical QA Committee guidance
All of the NHS Pharmaceutical QA Committee’s Yellow Cover documents.
- Detecting HEPA filter leaks using dispersed oil particle aerosols
- Quality Control chemical testing of aseptically prepared products
- Supervision of aseptic preparation under Section 10 exemption
- Validation master plans
- Computer Systems Validation
- Integrity of syringes for aseptically made medicines
- Vial Sharing in Aseptic Services
- Restricted to NHS: Managing particulate contamination of aseptic medicines
- Deriving and assessing stability data for medicines
- Validation of quality control analytical methods