REVISED ANNEX 14 PUBLISHED

Annex 14 of the GMP guide on the manufacture of medicinal products Derived from Human Blood or Plasma has been revised in the light of Directive 2002/98/EC and relevant implementing directives setting standards of quality and safety for the collection and testing of human blood and blood components for all uses, including the manufacture of medicinal products.  Deadline for coming into operation: 30 November 2011

PHARMACOVIGILENCE CONCEPT PAPER ISSUED

The EU consultation paper on new pharmacovigilence measures has been released. The deadline for comment is 07 Nov 2011. Download the concept paper here.

MHRA ISSUES ALERT FOR BD NEEDLES

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a device alert for sterile hypodermic needles manufactured by BD Medical. The company’s Microlance 30G x ½” needles may be blocked or partially blocked. BD Medical is asking customers to quarantine affected lots of the needles until recall can be arranged.

HEALTH CANADA OVERSEE RECALL DUE TO LABEL MIX-UP

Mylan Pharmaceuticals has started a voluntary recall of two drugs after a pharmacist noticed a prescription product containing the wrong medication. The products affected by the labeling error are one lot of the Mylan-Minocycline 50-milligram capsules in bottles of 100, and Mylan-Amlodipine five-milligram tablets in bottles of 100. A patient who is taking Mylan-Amlodipine to treat high blood pressure or angina could instead end up getting the other product, which is used for skin infections, urinary tract infections, gallbladder infections, and respiratory tract infections such as bronchitis, pneumonia and sinusitis .A patient who is sensitive or allergic to tetracyclines or minocyline could experience a life-threatening reaction. In addition, the patient wouldn't be getting the medication needed to control high blood pressure or angina.

BAXTER CASTLEBAR HALTS PRODUCTION TO RESOLVE ENDOTOXIN CONTAMINATION

Baxter has shut down a production area which manufactures peritoneal dialysis solutions following detection of Endotoxin in a small number of batches. Reports suggest that microscopic cracks in two production tanks are the suspected problem. Despite cleaning operations it now appears that the only option to eradicate the problem is to replace the equipment. This will result in the temporary loss of approx 150 jobs while this work is done.

The IMB and EMA were informed of the problem in December. Health alerts were issued to dialysis units advising vigilance to adverse reactions until alternatively sourced stocks were made available.

REVISION OF CHAPTER 6 (QUALITY CONTROL) - CONCEPT PAPER

The EMA have issued a concept paper to update this chapter. The update will consider the requirements of ICH Q8,Q9, Q10; draft Q11; ongoing revisions of Chapters 4 and 7 and Annex 11, the requirements of Annexes 16, 19 and 20; and new technologies and PAT. The quality of Technology Transfer validation is likely to be addressed also in light of recent comments that OOS trends indicate that there are often issues in this area. The concept paper is available here.

EMA PUBLISH CONCEPT PAPER ON STORAGE CONDITIONS DURING TRANSPORT

In preparation for a widely expected overhaul of GDP (Good Distribution Practice) requirements, a concept paper has been published on storage conditions during transport.

DRAFT OF CHAPTER 5 OF EU GUIDE PUBLISHED

The proposed revision of Chapter 5 on Production has been published. The revision has significant new requirements for the control exercised over suppliers, including the testing of starting materials by suppliers. The draft can be seen here.