A pharmaceutical manufacturer in India received a Warning Letter from the US-American FDA in December due to deficiencies in the areas of maintenance/cleanliness, OOS and data integrity. Read more here.
A US-American pharmaceutical manufacturer received a Warning Letter from the FDA in November 2019 due to microbial issues in the water system, deficiencies in qualification/validation and insufficient stability data. Read more here.
Stability testing of drug products is required by 21 CFR 211.166 of the cGMP guidelines. There has been an increase in GMP violations related to stability testing. A few days ago, a German company received an FDA Warning Letter in which, among others, the stability program was criticized.
During the transition period, all EU laws remain applicable in the UK. Does that mean that QP certification by UK QPs will still be valid across the EU? Not really, as a statement by the EQPA explains.
The USP has published the revised chapter on testing for non-visible particles <1788> as well as new monographs on the individual test methods light obscuration, membrane microscopy and flow imaging as drafts.
Anyone who has gradually lost track of the mass of information about nitrosamine impurities can now consult the EDQM website. Read more about where to find important documents, e.g. analytical methods of determination on the new EDQM website for nitrosamines.
The United States Pharmacopeia is currently introducing some changes to the format of the USP and to its Pharmacopeial Forum - a bimonthly online journal in which USP publishes proposed revisions for public review.
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Henan Kangdi Medical Devices Co. Ltd. due to, among others, the failure to establish an adequate stability program. Furthermore, the quality unit was not provided with the appropriate authority and sufficient resources to carry out its responsibilities.
The U.S. Food and Drug Administration (FDA) recently warned Teligent Pharma, Inc., for different significant violations of current good manufacturing practice (CGMP) at the company's facility in Buena, New Jersey. The FDA cites the company, among others, for failing to thoroughly investigate out-of-specification (OOS) test results.