Manufacturers of specials have guidance to consult as the Medicines and Healthcare Products Regulatory Agency (MHRA) has released an interpretation of GMP requirements for manufacturing unlicenced specials. The guidance titled, "MHRA Guidance for Specials Manufacturers," is presented in a question and answer (Q & A) format for ease of reading and reference. The Manufacturing Specials (MS) licence includes radiopharmaceuticals. The following is selected advice, however, the 41-page guidance is extensive and covers many issues relating to specials manufacturing.
Microorganisms are found everywhere. This can be in the air and water, on skin and other surfaces. When microbiological contamination occurs in pharmaceutical manufacturing, product batches are wasted, risking potential recalls and plant shutdowns. The effect of the contamination can include lost time and money for manufacturers, drug delays and shortages, and related loss of public confidence, potential fines and even criminal consequences.