FDA Warning Letter: Deficiencies in API / Finished Drug Product Testing and Stability Program
The United States Food and Drug Administration (FDA) has recently published a Warning Letter to a manufacturer of over-the-counter (OTC) drug products. The letter summarizes significant violations of current good manufacturing practices (CGMP) concerning finished drug product testing, identity testing of active pharmaceutical ingredients (APIs), and stability testing.
Numerous FDA 483s due to Deficiencies in the Stability Program
Stability studies of pharmaceuticals are a well-established discipline and, of course, an important regulatory requirement. Nevertheless, an evaluation of the last two fiscal years shows that deficiencies in the stability program are mentioned in numerous FDA 483s.
Lack of Scientifically Sound Laboratory Controls often mentioned in FDA 483s Reports
Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. An evaluation of the last two fiscal years shows that a lack of scientifically sound laboratory controls and not following/documenting laboratory controls are often mentioned in such FDA 483s.
Inadequate Sampling Plans lead to FDA 483 Inspection Report
Sampling of materials is one of the most important processes in pharmaceutical companies. An Indian company received a so-called 483 FDA report due to inadequate sampling plans for raw materials and intermediates. Furthermore, the FDA criticises that components used in manufacturing are not tested and released prior to use.
Important Change for Entries in EudraGMDP Database
The new regulatory framework for veterinary medicinal products requires several changes to the EudraGMDP database. One important change is the integration of EudraGMDP into the EMA's Organization Management Service (OMS).
The "Access Consortium", a consortium of the regulatory authorities from Australia (TGA), Canada (HBFB), Switzerland (Swissmedic), Singapore (HSA) and now also the United Kingdom (MHRA), published a three-year plan regarding planned common approaches and goals.
Absence of Approved Storage Facilities leads to GDP Non-Compliance Report
The competent authority of Czechia has added a new GPD Non-Compliance Report into the EudraGMDP database. The report states that the company concerned does not provide approved storage facilities and the services of a qualified person are not ensured.
Industry still facing Problems with Root Cause Investigations
Deviations and CAPA are still important issues during inspections. Inspectors' summaries of their observations show that things do not always work as they should. This also applies to root cause investigations.
API Testing in the Focus of the Inspections of the U.S. FDA
In May 2021, the U.S. FDA issued a Warning Letter to a Turkish over-the-counter (OTC) drug manufacturer called "Gulsah Uretim Kozmetik Sanayi Anonim Sirketi" due to significant violations of cGMP regulations for drug products.