Non-GLP

Picking Non-GLP vs GLP Studies for Drug Discovery and Development

Non-GLP or the Goods Laboratory Practises is a system wherein non-clinical health and safety studies are performed, monitored, reported and archived. The regulations mentioned under GLP subjects biotechnological organizations to adhere to the rigid biopharmaceutical

Non-GLP or the Goods Laboratory Practises is a system wherein non-clinical health and safety studies are performed, monitored, reported and archived. The regulations mentioned under GLP subjects biotechnological organizations to adhere to the rigid biopharmaceutical drug manufacturing standards. This is an important regulatory requirement for producing quality test data. The preliminary idea behind GLP implementation was building international standards in a mutually acceptable way amongst global organizations.

Some of the prime requisites of GLP standards are – 

  •   The laboratory management should ensure the recruitment of only qualified personnel in appropriate GLP authorized laboratories. Such laboratories should have all the required equipment, instruments, and materials. It is also essential to maintain a record of the staff qualifications and working system. 
  •   GLP standards require the laboratories to establish a QC system. This quality control system should be well-documented and accomplished by well-qualified staff. 
  •   The personnel employed in the GLP lab should ensure for exercising safe working conditions. Awareness about the cautious handling of both hazardous and non-hazardous chemicals is important.  
  •   The testing facility should be designed following the activity requirements of the establishment. This makes sure that each and every activity is performed under a separate assigned section of the testing facility. 
  •   The facilities should stringently adhere to the various cautions for handling both the test and reference substances. This may limit the occurrences of possible cross-contamination. The disposal of waste should be done aptly to minimize the jeopardization of the integrity of the progressing study. It is essential to carry forward the processes of waste collection, its storage and disposition appropriately and document it correctly. 

    Essential principles of Good Laboratory Practises – 
  •   Every drug research study should comprise of unique identification which makes it feasible to immediately, clearly, and legibly record all the concerning observations. 
  •   Whatever records are derived throughout the studies, all should be well documented within a bound notebook or numbered sheets piled up in the form of a file. 
  •   All the entries and collections reported and recorded should be dated and appropriately maintained. 
  •   Clear identification of the specimen should be well documented, which facilitates its smooth traceability. 
  •   In the end, all the raw data about the study should be assembled, catalogued and archived appropriately. 
  •   Quality Assurance team can be dispatched as an internal system for ensuring the proper implementation of the GLP principles. 

Applicability of the non-GLP studies – 

Non-GLP

The primary difference between the GLP and Non-GLP studies is the fact that not all the studies require the strict adherence of the GLP standards. Although GLP studies are mandatory requirements under regulations issued by the food and drugs administration, non-GLP studies do exist. The compliance of these non-GLP studies is acceptable in case of drug interaction studies and in vitro drug metabolism studies. Furthermore, there is no need for adherence to the GLP standards while working with the drug discovery, primary research and screening. This is so because there is no assessment of the drug’s safety in all these stages. Strict adherence to the GLP regulations comes into foreplay when you are extrapolating your studies to the human population. 

Leave a Reply

Your email address will not be published. Required fields are marked *