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.
Trending. The advice states that, as a minimum, trending of Environmental Monitoring data is required. This should be scheduled at least monthly with an annual review.
The agency notes that there is no mandatory requirement for MS manufacturers to produce a Product Quality Review (PQR), however regular periodic quality reviews are recommended, especially if numerous batches of the same product are manufactured.
Personnel authorised for batch release should have the appropriate level of experience and training. Releasing Officers should be named in the Quality System.
Contamination is addressed in a section on equipment, and the agency states that it still supports the use of spray and wipe as certain factors limit the widespread use of gassing.
It is expected that a risk assessment is carried out which details the justification for performing or not performing annual stability testing for each product. Factors such as use of the product, therapeutic index, patient population, shelf life, source of the formulation, end of shelf life testing if carried out, storage conditions etc. should be considered in the assessment.
For documentation, MHRA states that MS licence holders should have a Site Master File (SMF) unless they have a justification for not having one. The manufacturer should keep its batch documents for at least one (1) year after expiration or five (5) years after release, whichever is longer. The agency expects that many sites will keep records for much longer. The agency refers manufacturers to the EU GMP Annex 11 and 15 for further clarification.
LIMS software offers Specials manufacturers many features to help facilitate these and other regulatory requirements.
Learn more to review the full MHRA Guidance for Special Manufacturers by clicking here.
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