Please note:

Access to some of the content below is restricted and users need to be registered, and logged in to the SPS site with an NHS access level.

If there are any problems getting beyond this page using the links below, contact Sandra Wharton in the first instance (s.wharton@nhs.net).  If Sandra is out-of-office contact Ben Rehman (b.rehman@nhs.net) or Tim Root (tim.root@chelwest.nhs.uk).

A Guide to Quality Control Chemical Testing of Aseptically Prepared Products

(ATMPs)- The Role of Pharmacy in the Successful Delivery of Advanced Therapy Medicinal Products Information for Chief Pharmacists

Aseptic Preparation NHS Hospitals – Information For Microbiologist 1st Edition

Audit: Standard Operating Procedure for Undertaking and Reporting El(97)52 Audits, 8th Edition, January 2018

Audit: Visit by Quality Assurance Personnel to Pharmaceutical Manufacturers and Wholesalers 3rd Edition

Broth Fill: End of Session Broth Fill Technique for Sterility Assurance of Products Aseptically Prepared in Section 10 Units 1st Edition

Clean Room Garment Monitoring 1st Edition

Cleaning and Disinfection Regimens for Clean Rooms 1st Edition

Computer Systems Validation

Design, Build and Maintenance of Pharmacy Aseptic Units

Emergency Preparation of Eye Drops in Unlicensed Aseptic Units 1st Edition September 2019

Good Practices for the Preparation of Medicinal Products in Healthcare Establishments 1st Edition: Positional Statement by the NHSPQA Committee PIC/S

Guidance on the Pharmaceutical Issues Concerning Outpatient Parenteral Antibiotic Therapy (OPAT) and Other Outpatient IV Therapy Services

Guidance on Repackaging and Overlabelling Small Batches of Medicines in Pharmacy Departments

Measurement of HEPA filter performance using the dispersed oil particle aerosol test for leak detection in filter installations ed 3

Testing of Piped Medical Gases

MHRA website link

Microbiological Protocol for the Integrity Testing of Syringes, 2nd Edition April 2013

Monitoring of Isolators and Enclosed Spaces Sterilised by Hydrogen Peroxide Vapour 1st Edition

Monoclonal Antibody (mAb) Products: Guidance on Handling

Multiple Use of Injectable Medicines in Clinical Areas V02 February 2020

Pharmaceutical Isolators

Pharmacy Clinical Trials Activites 1st Edition

Pharmacy Intrathecal Chemotherapy Audit Aide Memoire 4th Edition

Procurement – Quality Assurance Policy to support the National Contract Procurement of Licensed Medicines

Purchase and Supply of Unlicensed Medicinal Products Guidance Notes for Prescribers and Pharmacists

The Responsibilities of Chief Pharmacists for Radiopharmaceuticals

Quality Assessment of Unlicensed Medicine

Quality Assurance of Aseptic Preparation Services: Standards Handbook 5th Edition 2016

Quality Assurance of Radiopharmaceuticals

Raw Materials: Guidance for the Approval of Suppliers of Raw Materials Used in the Manufacture of Unlicensed Medicinal Products 3rd Edition

Registration of Quality Controllers (MGPS)

Risk Associated with the Outsourcing of the Aseptic Compounding of Parenteral Nutrition

Risk Management of Medicines Stored in Clinical Areas: Temperature Control

Sampling Programme for GMP grade Controlled Environments, Section 10 Unlicensed Units 1st Edition

Sourcing and Supply of Ready-to-Administer Chemotherapy Doses for the NHS

Sporicidal Issues – Guidance for Aseptic Transfer Processes in the NHS: Addressing Sporicidal Issues

Standard Protocol for deriving and Assessment of Stability – Part 1 Aseptic Preparation (Small Molecules)

Standard Protocol for Deriving and Assessment of Stability -Part 2 Biopharmaceuticals

Standard Protocol for Deriving and Assessment of Stability – Part 3 Oral Liquid Medicines

Standard Protocol for Deriving and Assessment of Stability – Part 4 Parenteral Nutrition

Standard Protocol for Deriving and Assessment of Stability – Part 5 Sterile Products (End Sterilised Products)

Supervision as Applied to Section 10 Aseptic Preparation Activities

Supply of Aseptically Prepared Doses of IMPs Across Legal Boundaries, Version 2, October 2019

Testing of Piped Medical Gases 2nd Edition 

The Training of Auditors to Undertake Audits of Unlicensed Aspectic Dispensing in NHS Hospitals 2nd Edition

Unlicensed Imported Medicines – Guidance for the Overlabelling and Provision of Translated Information

Validation Master Plan 1st Edition

Validation of Pharmaceutical Quality Control Analytical Methods 1st Edition

Vial Sharing in Aseptic Services 1st Edition August 2014

Wholesale Distribution Authorisation Audit Edition 1 August 2014

 

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