#pharmecutical engineering

With the product lifecycle moving so fast, many organizations may ask the question, "How can we effectively measure quality?" The answer is risk management. Learn the elements of risk management and how they help to identify, prevent, and mitigate risk throughout an organization.

Download the white paper here.

This paper describes the approach and benefits of using DPT Labs’ QbD Formulation service and follows the previous paper in our Thought Leadership Series, “What is QbD and Why Should You Care?”

Containment technology has emerged as one of the major trends in the processing and manufacture of pharmaceuticals. Part of the reason for this is continuous quality improvement, which relies on new and improved containment technologies to enhance production. However, there has been a steep rise in interest in containment following medical trends leading to more volatile pharmaceuticals. Reasons for this include more targeted applications with larger molecules as well as a rise in biopharmaceuticals and anti-virals.

Environmental monitoring is an important aspect of regulatory and quality control in the production of pharmaceuticals. The manufacturing environment must be controlled and monitored during the production of drugs. Final drug products must be sterile and free from contamination.

Terminal sterilization and aseptic processing are the two paths taken to produce sterile drugs. Terminal sterilization is the process of sterilizing materials and containers, done with the material in its containers, with the product in its final form.

In aseptic filling or packaging, the individual components are sterilized separately and brought together in the final form in a sterile environment.

Sterile drugs should be manufactured by aseptic processing only when terminal sterilization is not feasible.

The greatest concern with the manufacturing of sterile drugs is viable microorganisms. With current technology, it is not possible to monitor these in real time Particle counters play an important part in determining the quality of the air during aseptic processing.

Components of an environmental monitoring program include:

Airborne nonviable particulate monitoring

Airborne viable contaminant monitoring

Viable contaminant monitoring of surfaces

Read More

The California State Assembly became the latest state legislature to move forward with bills that specifies requirements under which pharmacists can substitute biosimilars for brand-name products. The bill (SB-598) passed the California State Assembly on Aug. 26, 2013, and now moves to the California Senate for a final vote.

The bill, which amends California’s state pharmacy law, specifies that a pharmacist filling a prescription order for a prescribed biological product may select a biosimilar only if the product is approved by FDA and the prescriber (i.e., the doctor) does not personally indicate “do not substitute” for the product. For prescriptions filled prior to Jan. 1, 2017 for a biological product or interchangeable biosimilar, the pharmacist must notifiy the prescriber (i.e., doctor) whether the prescription dispensed was a biological product or interchangeable biosimilar or enter the information in a patient record system shared by the prescriber. The bill would prohibit a pharmacist from selecting a biosimilar unless the cost is the same or less than the cost of the prescribed biological product. The bill also requires that the substitution of a biosimilar be communicated to the patient.

State legislatures have become a key focal point for biosimilar as the industry waits for a final US regulatory pathway for biosimilars. The Patient Protection and Affordable Care of 2010, the landmark healthcare reform package signed into law (Public Law 111-148) by President Barack Obama on March 23, 2010, authorized a regulatory pathway for biosimilars (1). In February 2012, FDA issued three draft guidances relating to biosimilars (2-4), but these guidances have not been finalized. The approval pathway, as established by the federal law, distinguishes between biologic products that are “biosimilar” to an innovator biologic, meaning they are “highly similar” to an innovator product, and biologic products that meet a heightened standard to be deemed “interchangeable” (5). Although FDA’s role in the approval of biologic and biosimilar medicines includes the designation of an interchangeable status, the policy on whether one biologic product may be substituted by dispensers when a different biologic product was prescribed is governed by state law (5), and it is that issue that has been the recent focus of many state legislatures.

Read More

When you install a new continuous monitoring system in a controlled environment you have made an important investment towards reducing several kinds of risk that your company is vulnerable to. First, you have reduced the risk of ruined or adulterated product by installing a monitoring system with alarm capability. Second, you have reduced the risk of lost or missing data by way of devices and software that are designed with redundant memory storage. Any good continuous monitoring system is designed to meet the regulatory requirements that are part of the Pharmaceutical and Medical Device industries. Moreover, a system that meets regulatory requirements must be easy to learn and use or the functionality meant to ensure compliance may be sub-optimized.

Download the whitepaper here: 

Ensuring product quality is of utmost importance to the pharmaceutical industry, and appropriate controls and oversight are required for both the drug-manufacturing process and the supply chain for pharmaceutical ingredients. Several key measures in the United States and European Union that address these issues are progressing with either implementation or further discussion slated for July 2013.

European Falsified Medicines Directive  On top of the agenda is the implementation of the European Falsified Medicines Directive. The directive seeks to prevent falsified medicines entering the legal supply chain in the EU. The directive was adopted in July 2011, and EU member states began applying provisions in January 2013. The directive harmonizes and strengthens safety and control measures across Europe in four main areas: safety features of medicines, supply chain and good distribution practices (GDPs), active substances and excipients, and Internet sales (1, 2).

On the pharmaceutical ingredient side, beginning in July 2013, all active substances manufactured outside the EU and imported into the EU must be accompanied by a written confirmation from the regulatory authority of the exporting country. These statements are to be issued per manufacturing site and per active substance to ensure that standards of GMP equivalent to those in force in the EU are upheld, according to the directive (1, 2). Several countries have already committed to issuing written confirmations. Exporting countries with an "equivalent" regulatory framework will not need to issue these written confirmations. The European Commission (EC), together with the European Medicines Agency and member states, is assessing the regulatory frameworks of countries applying for equivalent status (1, 2).

Read More

Upcoming requirements in the US and around the world for serialization and track and trace of pharmaceuticals were a focus of the Pharmapack conference held in Philadelphia, PA earlier this week. Momentum toward implementing these technologies across packaging lines is building as deadlines, including California’s requirements in 2015 and others around the world, approach. After listening to several presentations and a panel discussion, the message I heard loud and clear was that time is of the essence and that packagers should prepare for serialization now.

Some companies have delayed working on serialization because US federal track-and-trace legislation is not yet in place, although a vote could come this summer. Regulations in California and other countries, however, are approaching deadlines for implementation. Many companies are moving forward despite federal delays, said panelists.

Read More