Method Validation

Method validation is one of the most crucial components in any regulatory submission. We can conduct method validations for various analytical methods from simple UV based assays to complex chromatographic methods for impurities and related substances. Our validation protocols and reports are based on globally acceptable guidelines like ICH/FDA/USP guidelines and cover various parameters.

Projects are designed to evaluate existing or new methods for meeting the performance criteria laid down in our validation protocol.

Expected Outcome: Validated method for implementation

Expected Outcome: Partially validated method transferred and fully validated at client side

A method validation project has the following steps

1) Request from client

2) Discussions with client

3) Development of draft validation protocol

4) Review of protocol by internal validation team and client representative

5) Issue of final protocol and initiation of validation exercise

6) Interim review of validation data by Quality Assurance

7) Submission of validation data to QA for review and compilation

8 ) Compilation of draft validation report

9) Review and approval of draft report by internal team and client representative

10) Compilation and approval of final report

11) Archival of final report, source data and electronic data

Method Transfer

If the client wishes that a method is to be transferred to their manufacturing site only a mini-validation is conducted in our facility and a joint full validation is conducted at the transfer site.

Requirements

The client is responsible for providing the following materials:

1) Drug reference and working standards

2) Impurity reference and working standards

3) Placebo; individual components and blend

4) The drug product (if the method is for a formulation)

5) In case of method transfer requiring full onsite validation all equipment and reagents and manpower required for validation

6) If any rare column or chemical is required for the analysis the same shall be billed additionally to the client or will have to be provided by the client

7) A designated contact person for all technical and administrative issues

Quality compliance and data archival

• All studies conducted shall be adherence to ICH guidelines an meeting all regulatory requirements.

• Client is free to visit and audit our facilities; systems and process at any time during or after the study.

• We shall provide you full support in answering any queries raised by the regulatory bodies about the data submitted to them.

• All data (source, electronic and final) shall be archived at our facilities for a period of 7 years or as desired by the client.