GLP Certification in Philippines, Good Laboratory Practices (GLP) are rules and guidelines for how nonclinical animal studies of drug safety are to be done. In addition to ensuring that animals are treated with respect and cared for, following GLP regulations shows that nonclinical safety data are valid, complete, and reliable. This nonclinical safety data will eventually be sent to regulatory agencies, who will look at it and decide whether it can be used in clinical studies with people.
When do you have to follow GLP Certification in Philippines?
Most nonclinical studies will have to follow the rules of the GLP regulation. But there are some times or stages in the early pre-clinical phase where GLP is unnecessary. Exploratory genotoxicity, mutagenicity, safety pharmacology, and general in-vitro toxicology studies are some examples of studies that might not have to follow GLP Certification in Philippines.
Sponsors may decide to do this stage of studies outside of GLP rules if they only want to look at the drug’s absorption, distribution, metabolism, and elimination (ADME) properties to find out how safe it is in the short term. The goal of these studies would be to first see how well the drug works in different systems.
This will lead to more research, which will be done in a study where GLP rules must be followed. Standard repeated dose toxicity, genotoxicity, and safety pharmacology studies are all examples of studies that need to follow GLP Certification in Philippines. In the end, all nonclinical trial results that will be sent along with an IND must have been done according to GLP rules.
CROs can help with GLP compliance in many ways.
A contract research organisation (CRO) can find experts in specific processes who can look at things from different points of view. CROs can be fair because they are not tied to the sponsor. Instead, they focus on the service they are providing rather than the success of the drug.
According to the rules, CROs must know their GLPs and any updates as soon as they come out. To stay in compliance, CROs can keep an eye on several metrics, such as:
- Keeping track of how many things go wrong.
- Where are they going wrong, and which version.
- Who asked for the change?
- Planned deviations vs unplanned ones.
- Changes every year or every three months.
The above metrics can help you learn more about why deviations are happening and how processes can be changed to stop them. Metrics are a great way to see how the organisation is doing in terms of GLP compliance and quality as a whole and to find places where it could improve.