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Over the decades, with the inception of strict Regulatory regimes, life sciences companies have launched numerous medicinal products in the market prioritizing the end user’s safety. But only few have remained popular sustaining the market competition while many fail to break the initial Regulatory barriers because of incompliant practices. To attain Regulatory compliance and expedite the medicinal product’s commercial launch, manufacturers / sponsors must realize the value of certain mandatory standards imposed by Regulatory bodies worldwide. Some of such standards to be followed while approaching the United States Food and Drug Administration (USFDA) include:
- Good Laboratory Practice (GLP)
- Good Clinical Practice (GCP)
- Good Manufacturing Practice (GMP)
Good Laboratory Practice (GLP)
As part of Investigational New Drug (IND) documentation, a toxicity report of a drug in laboratory animals must be attached along with several other documents. These lab studies and tests must be controlled and carried out as per the FDA defined GLPs. Some of them include:
- Ensure all applicable GLP are followed throughout the laboratory processes
- Establish a competent quality control / quality assurance (QA/QC) unit in a testing facility to maintain the master schedule and master testing schedule, and monitor the study, phase-wise
- Conduct nonclinical laboratory studies as per established protocol
- Ensure every individual engaged in the nonclinical laboratory study has the education, training and experience of performing the assigned function
Good Clinical Practice (GCP)
All clinical studies for a drug / biological medicine must be conducted in line with GCP regulations failing to do which (both intentional and unintentional) will lead to serious consequences for the clinical investigators. The essential GCPs includes:
- Ensure adequate application of informed consent procedures to protect the clinical subject
- Ensure thorough personal conduct or supervision of the principal investigator while delegating the tasks part of the clinical trial
- Secure and maintain, accurate and adequate case histories
- Ensure adequate monitoring of the study by the QA/QC unit
- Report unexpected clinical reactions to the Institutional Review Board (IRB) and the sponsor
Good Manufacturing Practice (GMP)
When it comes to a new drug development, as the development progresses the number of GMPs to be adhered to increases. Most often, they are related to the operating procedures or drug specification whose deviations must be duly documented after thorough investigation. Here are some common GMPs that must be strictly adhered to, right from the early stages of product development.
- Ensure adequate control of raw materials
- Develop and maintain adequate data on manufacturing process development
- Present validation data for manufacturing processes and analytical methods
- Maintain complete batch production/testing records
- Provide necessary justification for drug specifications
- Investigate SOP deviations and ensure adequate corrective and preventive action (CAPA) plans
- Provide ample training to the personnel to keep them in the know of current GMP knowledge
With the best practices clearly laid out by the global Health Authorities, it is important for companies to evaluate that how focussed are they in practicing them right from the first step. Strict adherence ensures a diligent approach in product launch. However, in some cases, as manufacturer’s focus clearly fixed on their core strength of medicinal product development, it is advisable to opt for a proven GxP practitioner for successful compliance and expedited product launch. Ensure the GxPs are implemented and practiced without a fail. Be compliant.
