The Medicines and Healthcare products Regulatory Agency (MHRA) has a responsibility to protect public health by ensuring that medicines and medical devices meet applicable standards of safety, quality and efficacy. Each year, they conduct
Is My Audit Trail Regulatory Compliant?
Operating a laboratory within regulatory requirements can be a challenge. The wording of regulations is typically cryptic, and there’s always room for different interpretations. Audit trails are an important factor for compliance because
The European Commission has published the final version of the revised EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release". Deadline for coming into operation is 15th April 2016.
MHRA Guidance for Specials Manufacturers
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.