During any new drug product development phase, developers have to conduct a degradant and impurity evaluation at varying degrees and several points in the program. An expert pharmaceutical consultant can help in this examination like active API identification as the drug product and substance. Global regulatory agencies like the FDA (Food and Drug Administration) expect recognition, qualification, and reporting of the compounds. It is dependent on the 3 guidance documents by the ICH.
A pharma consultant takes the help of these documents at various developmental stages and addresses particular concerns related to specific degradants or impurities. How and when the pharmaceutical consultant will implement the appropriate timing of the guidance documents is crucial for ignoring obstacles. It is also essential for successful product development for derailing or delaying the program.
What are the impurities in the new drug products or substances?
ICH Q3B (R2) indicates the new degradants in the drug products, and ICH Q3A (R2) indicates the impurities in the drug substances. These guidelines help in ignoring the obstacles before market approval of the drug. It further assists in extensive procedure changes, safety qualification efforts, or product reformulation.
ICH Q3B and ICH Q3A help in outlining the expectations for identifying, reporting, and qualifying degradants and impurities. The degradants and impurities that exceed the qualification limit or are not properly tested are identified in this development phase. A pharma consultant helps in qualifying the degradants and impurities safety as a group.
What are the degradants and Impurities Present in 505 (b) (2)?
Most of the development process in 505 (b) (2) is often accelerated. Thus, it becomes essential to be aware of the identified and potential issues in this phase. A reputed pharmaceutical consultant will make sure that the available information is enough for qualifying degradants or impurities. If any degradants or impurities are present in the new drug product at an equal or lower level in the representative approved product batches, then it is qualified.
How does a pharmaceutical consultant control and assess the DNA reactive impurities?
Another important document guideline that many pioneer pharma consultants follow in small molecular drugs is ICH M7 (R1). It offers a framework to identify, categorize, qualify, and control the mutagenic degradants and impurities for restricting carcinogenic threats. What distinguishes this guidance from ICH Q3B and ICH Q3A is it is applicable in all developmental stages along with the approval phase.
It primarily concentrates on DNA reactive substances potentially causing cancer. The question and answer segment in this document offers more clarity on implementing and interpreting particular items present in this guidance. According to the TTC (Threshold of Toxicological Concern), if the concentrations of degradants and impurities are above the mentioned level, they should be evaluated and identified for mutagenicity.
A pharmaceutical consultant also recognizes and considers the impurities that can form. ICH M7 also offers restrictions on PDEs or Permissible Daily Exposures for a particular mutagenic impurities set. These include conducting a bacterial mutagenicity assay to rule out QSAR structure-centric concerns. An expert rule and a statistical-centric model are necessary for validating and complementing the QSAR models.
FAQ
What is the key role of a pharmaceutical consultant in new drug evaluation?
A pharma consultant advises the drug manufacturers on the pharmaceutical development and sales. They have immense knowledge about the industrial regulations to aid and allow the companies to efficiently deliver medical treatments to those who are in need.
End Thoughts
It is vital to be aware of any degradants or impurities during the drug development to take ideal actions and ensure continued program progress. An experienced pharmaceutical consultant can address the difficulties that arise because of the degradants or the impurities. Their knowledge about regulatory pathways all around the world offers support to the development of high-quality pharmaceutical drugs, QSAR assessment, and impurity qualification.