India continues to be the place were many manufacturing sites are found to be out of GMP compliance. This time POLYDRUG LABORATORIES was inspected and 17 GMP compliance violations were found. Read more about the GMP-Non Compliance Statement.
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.
For the systematic review of the topicality of monographs and list entries the HMPC has updated a procedure which is supposed to ensure that this information is reviewed every 5 years. Find out more about the EMA/HMPC Document for systematic Review.
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 USP Chapter <1207> on the integrity testing of primary containers of sterile dosage forms is currently in the second round of review. Its adoption is expected for this year. Find out more about USP Chapter <1207>.
A USP article published in the Pharmacopoeia Forum discusses an improved method for the determination of the water vapour permeability in packaging for solid dosage forms such as tablets or capsules. Find out more about the optimization of the water vapour permeability test for packing materials.
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.
Ilisa Bernstein, Deputy Director of FDA's Center for Drug Evaluation and Research's Office of Compliance, shares her thoughts on the important role drug supply chain integrity plays in patient safety and quality care.
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.
On 1 April the Indian Ministry of Commerce and Industry has supplemented a paragraph that substantiates the actual requirements and the timeline for the implementation of the Track and Trace system for the export of medicinal products. Read more about the Indian Track&Trace System.
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.
One of the main demands of the Guideline ICH Q3D is to carry out risk assessments on metallic impurities. A database with analytical data provides a valuable support. Learn more about the data sharing using the new elemental impurities database.
The HMA (Heads of Medicines Agencies) and the EMA (European Medicines Agency) have issued a high level EU document in order to plan the strategy of the EU regulators for the upcoming 5 years. On 27 March 2015 a consultation draft entitled "EU Medicines Agencies Network Strategy to 2020" has been published. Please read more about the strategy plan of EMA and HMA.
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.
One of the largest scandals with regard to data integrity and data manipulation has been detected by French Inspectors of the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) in India. But the government in India will not accept the finding. Read more about the data integrity and data manipulation issues observed at GVK and the consequences.