ISO/IEC 17025:2017 (NABL) Certification for Drugs & Pharmaceuticals
Drugs and Pharmaceuticals
Drugs and Pharmaceuticals are an integral part of modern day lifestyle. There are numerous conditions that need the support of the drugs and pharmaceuticals for recovery. These pharmaceuticals are not only used for treatment of various conditions but also help the human body to retain a health state. As these products impact the health of the consumers, there is a need to keep a close watch on the quality and production of these products. The FDA or food and drug administration acts as a watch dog for products and quality control of drugs and other pharmaceutical products.
There are several phases of drug development which must be followed by the drug development company for a safe drug creation. Let’s see what these phases of drug development are.
The first phase is discovery and development. Discovery of a drug involved the research done by the researchers to find out different possibility of a medication or a drug by studying and testing the molecular structure of different compounds and then find out some other effects that it might have that are different from other treatments that are already available in the market. Development phase also focuses on finding out different ways to target a particular drug on a certain site of the body. Also the studies regarding the proper dosage, modes of administration of a drug and other aspects as well are conducted.
After the development phase, comes the preclinical research. In this phase, the researchers look out for any potential toxicity of the drug that is being studied. The preclinical research can be done in two ways, in vitro and in vivo. With in-vitro, the research is done in a controlled environment outside an organism. This method of research does not need a living organism to conduct the research. On the other hand, the in-vivo method of research is conducted inside a living organism to study the behaviour of the drug inside an organism.
After the preclinical research, the research goes into phase 3. This phase is clinical research. In this phase, the safety of the drug is determined and is tried on a controlled group of human participants. Humans are given the drug and are monitored closely for effects and side effects.
Once the research facility can prove the drug’s safety on humans, it can go for FDA approvals. Once the drug is approved by the FDA, it can be launched in the market.
For best results and safety, the research facilities must follow the GLP which basically outline the requirement for research facilities and equipments. This is possible when the testing laboratory is accredited by NABL
and ISO 17025: 2017 certification. This certification ensures that the lab is efficient enough to conduct various clinical and preclinical research procedures in a controlled and safe environment.
In case, you have Drugs & Pharmaceuticals equipment testing lab then you must get it certified for ISO 17025: 2017 – NABL, PrimeCertification
can help you with all the formalities involved with the ISO 17025: 2017 NABL certification for Drugs & Pharmaceuticals equipment testing lab process. We have a vast team of highly experienced professionals who have been helping our clients in getting an easy ISO 17025: 2017 NABL certification for Drugs & Pharmaceuticals equipment testing lab by handling all the audits, inspections, and paper works.