Pharma Talk

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

If a pressure gauge is not calibrated within its scheduled date, it can lead to several quality risks:  * Inaccurate Measurements: An uncalibrated gauge may provide readings that are significantly different from the true pressure. This can result in errors in processes, calculations, and decision-making.  * Non-Compliance: Many industries have regulations or standards that require regular calibration of pressure gauges. Non-compliance can lead to fines, penalties, and damage to the organization's reputation.  * Product Defects: Inaccurate pressure measurements can lead to product defects, especially in processes that rely on precise pressure control. This can result in wasted materials, rework, and customer dissatisfaction.  * Safety Hazards: Inaccurate pressure readings can pose safety hazards, particularly in applications involving hazardous materials or equipment. For example, a faulty gauge might indicate a lower pressure than is actually present, leading to an unsafe operating

Specificity in a potentiometric assay refers to the ability of the method to measure the analyte of interest without interference from other substances. This is crucial to ensure accurate and reliable results. Methods to Assess Specificity Here are some common methods to evaluate the specificity of a potentiometric assay:  * Blank Analysis:    * Purpose: To determine the baseline signal or response in the absence of the analyte.    * Procedure: Prepare a blank sample containing all the reagents and solvents used in the assay except for the analyte. Measure the potential or response.    * Evaluation: If the blank signal is significantly low compared to the signal obtained with the analyte, it indicates good specificity.  * Matrix Effect Study:    * Purpose: To investigate how different matrices (e.g., excipients, impurities) can affect the assay's response.    * Procedure: Prepare samples with varying concentrations of the analyte in different matrices. Measure the potential or resp

On 05 August, the FDA issued a warning letter to the US company LS Promotions Inc. in Hicksville. The warning letter is the result of a review of the company's responses to a 483 letter from the FDA. It summarises the violations of Current Good Manufacturing Practice (CGMP) for finished drug products under Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 21) found during the inspection as follows. Laboratory Testing Adequate laboratory testing was not performed on each batch of manufactured drug product prior to release to ensure compliance with specifications, including the identity and strength of the active ingredients. Similarly, microbiological testing was not carried out, although this is required for certain products, such as SPF 15 lip balm, SPF 30 sunscreen and hand sanitiser. The lack of testing means that it is not certain whether the products meet the specifications. The FDA therefore expects the company to provide a list of chemical a

In July 2024, the  nitrosamine Q&A document  "Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorization holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products" of the EMA/CMDh was revised again and published on the EMA website under "Questions and answers". This list of questions and answers was first published in 2020. The new version 21 now contains updates and changes in the following questions and their answers: 8. How should confirmatory tests be conducted by MAHs and manufacturers? 9. What are the requirements of the analytical method(s)? 10. Which limits apply for nitrosamines in medicinal products? 14. What is the approach for new and ongoing marketing authorisation applications (MAA)?  15. When should a test for nitrosamines be included in the MA dossier? 16. What are the responsibilities of MAHs for APIs with CEPs or ASMFs? The

From 1 July 2024, the Australian TGA will introduce, at least temporarily,  new regulations for GMP inspections  of domestic and foreign manufacturers of medicinal products, active pharmaceutical ingredients (APIs), biological products and blood products, so-called surveillance inspections. These are repeat inspections of manufacturers with a shorter duration, but according to the TGA with full scope. This means that the inspection should cover all aspects of the pharmaceutical quality system (PQS) and the operations, but be reduced by around 50 % of the usual inspection time. The GMP certificates issued after the inspection will then state that a surveillance inspection has been carried out. Who is eligible for this? Both domestic and foreign manufacturers who received a " good " or " satisfactory " rating (A1 or A2) in their last TGA inspection. However, there are also clearly defined exceptions where shortened inspections are not possible. Objectives The primary

advantage is that the increased temperature also reaches areas that are difficult to access, such as branch pipes, if the duration of the thermal sanitization is long enough. Temperatures of 70-80 °C are common. Hot systems are therefore self-sanitizing. Conclusion The removal of biofilms from pharmaceutical water systems is difficult. Therefore, the measure should not be the removal of a biofilm, but the prevention of such a biofilm. An appropriate system design is essential for this (no dead leg, stub lines, cold spots, etc.). Ozonization of the system is very helpful in preventing biofilm. Regular heating of the entire system is also a good prevention strategy. The most important aspect, however, is to avoid stagnant water. This applies to the entire system as well as to individual components, which should be able to be drained. The water system should therefore not be left standing over the weekend, but should rather be producing water in the design. The motto is: "keep it run