GMP NEWS 2015

After the WHO had released the second draft of the guideline for the design of hold time studies in March already, it now released the final version as part of the Technical Report Series 992. Find out more about the Guideline for Hold Time Studies.

The WHO has published a set of technical guidance documents giving interesting and detailed information on temperature-controlled transport operations. Read more in the technical supplements to Model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products.

The GMP/GDP Inspectors Working Party is planning to implement a new Annex 21 to the EU GMP Guidelines focussing on the import of medicinal products.

The USP has described the future requirements for the integrity of pharmaceutical packaging in the Pharmacopeial Forum. New proposals about the content have been published - now in form of 4 general chapters on the integrity of packaging materials. Find out more about the new USP Chapters on the Integrity of Pharmaceutical Packaging.

The installation of pipework leads to recurrent discussions about how dead legs can be prevented and about the maximum length of outgoing pipes. In most cases the 3D/6D rule is used as an argument, but not always in a correct way. Learn more about the 3D/6D rule.

The VDI published the standard 2083, part 2 final in April. In principle, this standard summarises the requirements on clean rooms according to VDI 2083 part 1and 3 as well as DIN EN ISO 14644-1 and -3 together and indicates the time intervals at which compliance with the requirements should be checked. Read more about VDI 2083 part 2.

The ECA Foundation and the Pharmaceutical Quality Group (PQG) have been working on the interpretation of different chapters of the EU GDP Guideline. Now the group has finalized the work on chapter 6 - Complaints, Returns, Suspected Falsified Medicinal Products & Medicinal Product Recalls. Read more about the GDP Guidance Chapter 6.

Mid of April PIC/S has taken over the revised Annex 15 of the EU GMP Guide on Validation and Qualification in their GMP Guide. Learn more about the PIC/S takeover of Annex 15.

Just recently we reported about the counterfeited HIV drug Viread (Tenofovir) from Gilead and how the counterfeited Viread packs had penetrated into the legal supply chain. At that time a parallel importer had detected the deviations and could therefore stop the further distribution. Now, promptly another two cases came up. Read more about the counterfeiting of the drug Humira.