Preparing

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.

Standard Protocol for Deriving and Assessment of Stability - Part 2: Aseptic Preparations (Biopharmaceuticals)

6 March 2017Stability of the protein structure is an important feature in preserving the safety and efficacy of biopharmaceuticals.

SPS at the Quality Assurance and Technical Services Symposium

16 April 2024

Requirements for Governance and Preparation of Gene Therapy

6 February 2024Practical advice for centres implementing Gene Therapies detailing GMSC and Governance requirements and optimal preparation location.

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