**1. Introduction**

The United States of America (USA), Europe and Japan were developed the Common Technical Document (CTD) which should be implement while applying for registration of pharmaceutical product for human use. For the development of these guidelines International conference for Harmonization (ICH) plays important role and currently these are becoming the part of ICH guidelines [1]. The identity, strength, quality, purity and potency are important points of Investigational new drug application (IND), New drug application (NDA), Abbreviated new drug application (ANDA). The related analytical methods of drug substance and product should be included in NDA and ANDA. A Complete description, total manufacturing process including analytical procedures should

ensure compliance with standards and potency should be part of Biologics license application (BLA). It is must to meet all standards of guidelines provided for analytical procedures. All these parameters should be suitable for their purpose wherever applicable. Detail Analytical procedures including detail validation parameters are the important part of Electronic Common Technical Document Specification as per International conference of Harmonization (ICH). The analytical procedure is Food and Drug Approved (FDA) if it a part of Approved NDA, ANDA or BLA. These methods can be generated from FDA recognized sources like U. S. Pharmacopeia/National Formulary (USP/NF) or if anyone submits validated procedure that will be accepted by FDA. The only validation or verification data of FDA approved methods of new products are considered for applications to various drug products (**Figure 1**).

Every manufacturer must generate large amount of corrected data for safety and efficacy of drug for commercial viewpoint. As it is mandatory to follow Current Good Manufacturing practices (cGMPs) for manufacturing purpose, likewise each analytical activity must follow Good Analytical Practices.

Method Validation, calibrated instrument, and training are three important tasks of Good analytical practices (GAPs). Commercially available dosage form is an outcome of several steps which are systematically carried out during product development. It is very important that all steps should be carried in systematic manner to ensure complete drug development stage. In recent years there is special focus on efficiency and efficacy of drug product and for this clinical study is most important task but apart from this there are various behind the scene activities are associated with drug development process without which pharmaceutical drug development is not possible. Among these behind the scene activities Method Development and Validation has its own uniqueness to ensure the drug development.

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*Analytical, Bioanalytical, Stability-Indicating Methods: Key Part of Regulatory Submissions*

The objective and plan of work should be clearly defined prior to start the work. This data is based on scientific findings from the method development and Optimization. The validation of results should be obtained by approved protocol. Then sponsor must follow cGMP's which includes detail procedure, validation characteristics and acceptance criteria by the use of qualified instrumentation. All the protocols of drug substance and product analytes in respective matrices should be prepared and followed. All the results of validation studies, application should be included.

The analytical procedure official in pharmacopeias, are cross checked for implementation stage and its suitability should be checked. The verification protocol should include details of data which explains suitable analytical procedure official

1.The compendia method which should be verified with acceptance criteria's.

2.All parameters related to each aspect of method that is reagent, equipment, validation characteristics that is specificity, Limit of quantitation (LOQ ), Precision, accuracy, should be included in validation are covered by procedure and extent of verification. There is no need to include robustness study for compendia assays if there is no deviation. For a BLA, if the methods are already specified in FDA regulations, there is must to take pre-approval from

The statistical analysis is important work after finishing the method development and validation. The statistical values of validation are compared with the

The statistical parameters used are based on proper principle and required for evaluation of parameter. The methods like analysis of variance (ANOVA) for analysis

for studying validation characteristics. In case of observed data is not distributed then it is transformed normal distribution or distribution free approach. By using validates

software or independent verification for correctness the data can be analyzed.

parameters are depending on method or procedure under validation. System suitability can be evaluated according to following points:

Before starting actual analysis of standard sample, it is necessary to check whether system is working properly or not. This important task can be completed by analyzing system suitability. In this all integral system that is equipment, electronics, analytical operations and samples are evaluated. These system suitability

1.The system suitability measures the performance of given system of samples on a given day. 2. The variable parameters like chromatographic columns, column aging, mobile-phase variations, changes in instrumentation are checked

**3.2 System suitability requirement for potency assay**

whether they are working properly or not.


The following points are to be included in the verification protocol

*DOI: http://dx.doi.org/10.5772/intechopen.93566*

**3. Compendial analytical procedures**

in USP/NF for drug product or drug substance.

FDA to change in analytical method.

**3.1 Statistical analysis**

of regression analysis, (R2

predetermined acceptance criteria.

**2. Noncompendial analytical method validation**

**Figure 1.** *Flow chart showing essential requirements of registration of pharmaceutical product.*

*Analytical, Bioanalytical, Stability-Indicating Methods: Key Part of Regulatory Submissions DOI: http://dx.doi.org/10.5772/intechopen.93566*
