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Guidance on Definition of Supervision under Section 10 Aseptic Preparation Activities, 3rd Edition, Sep 2019 (Yellow Cover)

3 September 2019The NHS Aseptic Services Accreditation Working Group, working closely with the South West Product Approval Accreditation Programme have developed and published a definition of Supervision…

Requirements for Governance and Preparation of Gene Therapy: Pan UK Pharmacy Working Group for ATMPs

30 October 2019Practical advice for centres implementing Gene Therapies detailing GMSC and Governance requirements and optimal preparation location.

Explaining Section 10 exemption

17 September 2004Pharmacists are exempt from licensing requirements pertaining to the provision of medicines in certain circumstances, as described

Guidance for the Approval of Suppliers of Raw Materials Used in the Manufacture of Unlicensed Medicinal Products 3rd edition (Yellow Cover)

25 May 2010This document is intended to provide a guidance framework for NHS Specials’ manufacturing activity for a consistent and risk-based approach to evaluate and approve suppliers…

Repacking and over-labelling small batches of medicines

1 October 2020Smaller packs of licensed medicines can be produced for clinics and departments by their hospital pharmacy, under pharmacist supervision in accordance with GMP

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

29 February 2016This document is intended to cover stability testing of all oral liquid formulations including suspensions, emulsions, solutions and powders for reconstitution

Advice on the preparation and/or administration of contrast agents supplied under a Patient Group Direction

12 August 2020

Labelling and packaging of unlicensed medicines (Specials): best practice guidance for the NHS

1 March 2022National guidance from NHSE/I to reduce LASA errors and improve patient safety when considering requirements for unlicensed specials medicines

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

1 June 2017To support NHS compounding units and purchasers to derive and assess stability data for pharmaceutical products (Specials and extemporaneously compounded).

Standard Protocol for Deriving and Assessment of Stability - Part 5 Sterile Products

1 June 2017This protocol applies to small molecule products of all presentations, manufactured from non-sterile starting materials and sterilised in their final container.