Pharma Talk

In a recent Warning Letter, the FDA has criticised inadequate equipment qualification and deficiencies in process validation. What does the FDA require? The deficiencies at the inspected company also occurred during past FDA inspections in 2014 and 2016. The company responded to the 483 deficiency report by stating that they will validate the processes used to manufacture all future medicinal products. They also said they were discussing internally revisions to calibration and preventive maintenance practices. This was not enough for the FDA, in particular a retrospective assessment of the potential impact was requested. Furthermore, the FDA still expects: Corrective actions to better ensure ongoing management oversight throughout the manufacturing cycle of all medicinal products. A data-driven and science-based programme that identifies causes of process variability and ensures that manufacturing (including packaging) meets appropriate parameters and quality standards. This includes -

When planning new purified water (PW) systems, the question arises as part of the risk analysis or later, when drawing up the qualification and sampling plans as to whether endotoxins should be tested for. According to the specifications of the pharmacopoeias (e.g. USP or Ph.Eur.), endotoxin testing is not required for Purified Water. The endotoxin content is not a test parameter in the valid pharmacopoeia monographs for purified water. However, if purified water is used as feed water for distillation plants and pure steam generators for the production of WFI (water for injection) or pure steam, it may be useful to test for endotoxins as part of the qualification process. This is due to the fact that distillation systems and pure steam generators - depending on the technology and manufacturer - can only achieve a reduction of 3 to 6 log levels of endotoxins. For the validation of the water system, the performance of the purification process must be proven. This applies to all quality p

Swiss medic took new step towards its own database to post GMP/CDP certificate  The Swiss health authority Swissmedic launched the SwissGMDP Database, similar to the European Medicine Agency's (EMA) EudraGMDP database. It lists the GMP and GDP certificates of all companies in Switzerland with a valid establishment licence issued by Swissmedic. The certificates in the SwissGMDP database include all authorised activities, i.e. unlike EudraGMDP, the GDP activities and Switzerland-specific GMP activities of Swiss companies will also be listed in the certificates. All companies, authorities and individuals can easily view a company's GMP/GDP status using the SwissGMDP database. Furthermore, SwissGMDP enables a query of all establishment licence holders with a valid establishment license including their sites and licenced operations and will replace the previous table of establishment licence holders. The SwissGMDP database offers: Public access for all users; Free-of-charge access t

Additional substantive information I. Background The FDA uses the term ‘peptide’ in this notice to refer to alpha-amino acid polymers consisting of 40 or fewer amino acids. Peptides can be isolated from natural sources or produced synthetically or by recombinant expression in a host cell. Peptides isolated from recombinant sources (i.e., genetically modified) prokaryotic or eukaryotic host cells by cell culture/fermentation processes are referred to as recombinant peptides (rPeptides). The FDA describes at this point: HCPs are process-derived impurities from the host cell that copurify with the recombinant peptide of interest and may be present in the final drug product. HCPs are characterised and routinely well controlled during the manufacture of the peptide product. The types and amounts of HCPs in a product depend on many parameters, including differences in the substrate of the expression cells, culture conditions, purification procedure and between different facilities. Therefore

The U.S. Food and Drug Administration (FDA) issued a Warning Letter dated 03 September 2024 to a Canadian over-the-counter (OTC) product manufacturer. The letter follows an inspection conducted in April 2024, discovering multiple violations of Current Good Manufacturing Practices (CGMP). Key Findings Key findings of the FDA include:  Failure to Perform Identity Testing on Components: The company did not adequately perform identity testing for all incoming components used in drug manufacturing. The firm's failure to conduct these tests raises concerns about the potential for contamination or mislabeling of their products. The company also relied on certificates of analysis (COA) from suppliers without verifying the identity of the components themselves, which further compounded the issue. Inadequate Validation of Manufacturing Processes: Another significant issue identified by the FDA was the company's failure to adequately validate its manufacturing processes. The inspection re

With the introduction of the updated FDA guidance on process validation, a process validation life cycle was introduced in 2011. One of the stages in the cycle is the so-called Continued Process Verification stage 3, which shows whether the process remains permanently in a validated state. Many companies use statistical process control (SPC) to show the 'state of control' in this stage 3.   In a recent Warning Letter, the FDA criticised a drug manufacturer's statistical process control. What was criticised? No control charts created The methods used in the 'Continued Process Verification' to show the 'state of control' are not specified. One possibility mentioned in the Process Validation Guidance is statistical process control. This is what the company inspected by the FDA had planned. Was it intended that way? Yes, that is how it was intended. Citing section 21 CFR 210/211, the FDA criticises the lack of activities that show that the process is permanently

The BioShield Act of 2004 significantly influenced the pharmaceutical industry, particularly in the development and production of medical countermeasures (MCMs) against biological threats. Here's a breakdown of its primary impacts: Increased Funding and Investment  * Government Funding: The Act provided substantial funding to the U.S. government for the development and acquisition of MCMs.  * Industry Investment: This increased government funding incentivized pharmaceutical companies to invest more in R&D for MCMs, which might have been considered riskier before the Act. Accelerated Development and Approval  * Expedited Processes: The Act introduced expedited development and approval processes for MCMs, reducing the time it took to bring products to market.  * Faster Response: This was especially crucial during public health emergencies, as it allowed for a quicker response to biological threats. Public-Private Partnerships  * Collaboration: The Act encouraged collaboration bet

Introduction Biosimilars, often referred to as biological generics, are a relatively new addition to the pharmaceutical landscape. They offer a promising solution to the high costs associated with many biological medications. In this blog post, we'll delve into what biosimilars are, how they differ from generic drugs, and the impact they're having on healthcare. What are Biosimilars? Biosimilars are highly similar to original biological drugs (also known as biologics) but are produced by different manufacturers. Unlike generic drugs, which are chemically identical to their brand-name counterparts, biosimilars are produced using biological processes and may have minor differences in their structure or manufacturing process. The Difference Between Biosimilars and Generic Drugs The key difference between biosimilars and generic drugs lies in the complexity of the molecules they mimic. While generic drugs can be chemically synthesized, biologics are often proteins or other complex

The Swiss Federal Council has discussed measures to improve the supply of medicines in Switzerland and is endeavouring to implement a number of measures. In view of increasing global shortages, storage obligations for essential medicines are to be extended, price reductions partially suspended and imports simplified. The aim is to secure the production of essential medicines and better prepare Switzerland for pandemics. A panel of experts is to draw up additional measures. The measures envisaged by the Federal Council to combat drug shortages include the following points: The stockpiling obligation for essential medicines is to be extended to ensure supplies also in times of crisis. Planned price reductions for certain medicines will be temporarily suspended so as not to jeopardise availability on the market. The federal government should be able to conclude capacity contracts with manufacturers to ensure the production of certain quantities of certain medicines. The extent to which th