GuidanceMHRA
Guidance for 'specials' manufacturers
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
First published: Jan 30, 2015Last updated: Feb 25, 2021Changes: 2
Latest change: A major update to the manufacture of sterile medicinal products section to add: 1. A definition of an aseptic manipulation. 2. A definition of a compounded intermediate for use in further process, for example parenteral nutrition (PN) manufacture. 3. Guidance on additional risk reducing factors to be used when producing compounded intermediates. 4. The elements to be included in a contamination control strategy Other minor changes to the formatting and numbering of existing guidance.
The full document, source attachments, and change history are available on KeyPedia. Sign in to view.