1.0 OBJECTIVE
To define the Analytical Procedures types.
2.0 SCOPE
This procedure is Applicable to define the Analytical Procedures types.
3.0 RESPONSIBILITY
3.1 QC-Chemist
4.0 ACCOUNTABILITY
4.1 Executive – Quality
control
4.2 Head – Quality
control
5.1 Analytical procedures are used to evaluate characteristics of the drug substance. Analytical procedures are classified into three types. There are
1. Regulatory analytical procedures
2. Alternative Analytical procedures
3. Stability Indicating Methods
5.2 Regulatory Analytical Procedures or Compendial Methods
The analytical procedures which are defined in the USP/EP/EP/JP/IP etc.. are termed as regulatory analytical procedure for a particular Drug substance. If the manufacturer claims that his/her material is EPgrade, then the manufacturer must analyse the drug substances as per the procedures given in the EP and the material must meet the specifications given by EP.
Eg: Famotidine, Ciprofloxacin Hydrochloride etc..
5.3 Alternative Analytical Procedures or In-House procedures:
There are situations were the regulatory analytical procedures may not be sufficient to analyze the drug substance, in such cases applicant can come up with own analytical methods. These methods are called as alternative analytical procedures. The method should be same or better than the regulatory method and fully validated and also comparative to the regulatory analytical procedures.
5.4 Stability Indicating Methods(SIM):
A SIM is a quantitative analytical procedure used to detect a decrease in the amount of the active pharmaceutical ingredient (API) present due to degradation.
According to FDA guidelines, a SIM is defined as a validated analytical procedure that accurately and precisely measures active ingredients (drug substance or drug product) free from potential interferences like degradation products, process impurities, excipients, or other potential impurities.
All the assaying procedures(such as assay of drugs, impurities etc..) for stability studies be stability indicating.
1. Regulatory analytical procedures
2. Alternative Analytical procedures
3. Stability Indicating Methods
5.2 Regulatory Analytical Procedures or Compendial Methods
The analytical procedures which are defined in the USP/EP/EP/JP/IP etc.. are termed as regulatory analytical procedure for a particular Drug substance. If the manufacturer claims that his/her material is EPgrade, then the manufacturer must analyse the drug substances as per the procedures given in the EP and the material must meet the specifications given by EP.
Eg: Famotidine, Ciprofloxacin Hydrochloride etc..
5.3 Alternative Analytical Procedures or In-House procedures:
There are situations were the regulatory analytical procedures may not be sufficient to analyze the drug substance, in such cases applicant can come up with own analytical methods. These methods are called as alternative analytical procedures. The method should be same or better than the regulatory method and fully validated and also comparative to the regulatory analytical procedures.
5.4 Stability Indicating Methods(SIM):
A SIM is a quantitative analytical procedure used to detect a decrease in the amount of the active pharmaceutical ingredient (API) present due to degradation.
According to FDA guidelines, a SIM is defined as a validated analytical procedure that accurately and precisely measures active ingredients (drug substance or drug product) free from potential interferences like degradation products, process impurities, excipients, or other potential impurities.
All the assaying procedures(such as assay of drugs, impurities etc..) for stability studies be stability indicating.
6.0 ANNEXURES
Nil
.JPG)
![Difference between Stability[Shelf life] Specification and Release Specification](https://4.bp.blogspot.com/-O3EpVMWcoKw/WxY6-6I4--I/AAAAAAAAB2s/KzC0FqUQtkMdw7VzT6oOR_8vbZO6EJc-ACK4BGAYYCw/w680/nth.png)
0 Comments