Guidance for 'specials' manufacturers
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
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.
AI Summary
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance for Manufacturers Specials (MS) licence holders regarding the 'packing down' and aseptic preparation of unlicensed medicines. This revision, originally published in 2013 and updated based on recent inspection findings, clarifies necessary interpretations of Good Manufacturing Practice (GMP) for products manufactured using closed systems. The primary focus of the document is to enhance sterility assurance through improved operational standards. Key technical areas identified for improvement include cleaning validation, pooling procedures, the use of sporicidal agents for disinfection, eye drop manufacturing protocols, and the identification of microorganisms. To ensure compliance, the MHRA requires most changes to be implemented within a three-month timeframe. However, more significant updates related to sterility assurance—such as cleaning validation and pooling—must be completed within six months of the document's publication. During this transition period, licence holders are explicitly required to perform interim risk-reduction actions to mitigate potential safety risks. This regulatory framework ensures that manufacturers of unlicensed medicines maintain high safety standards while adapting their processes to meet the latest MHRA expectations.
The full document, source attachments, and change history are available on KeyPedia. Sign in to view.