Method Development & Validation
Analytical Method Development & Validation
Vital in the pharmaceutical industry, analytical method development and validation ensures relevant, precise and reproducible results. At Precise Analytics Lab., we offer regulatory-focused, phase-appropriate and sample-specific technology for pharmaceutical validation and method development.
Our development and validation methods for pharmaceutical industry conform to the regulatory requirements prescribed in relevant ICH, USP and other pharmacopoeia guidelines. We also emphasise on maintaining client-specific protocols in our analytical method development and validation processes. Sophisticated analytical technology, latest know-how of chemicals and drugs, and thorough understanding of current regulatory practices guarantee sensitive, accurate, specific and precise results.
We undertake analytical method development and validations for chemical and pharmaceutical analytical procedures. The samples are tested against the following validation parameters:
- Specificity
- Linearity and Range
- Accuracy
- Precision
- Repeatability
- Intermediate Precision
- Limit of Detection and Limit of Quantification
- Robustness
Process Validation
We undertake analytical method development comprising process validation and cleaning validation for pharmaceutical products and bulk drugs.
Process validation is a documented series of actions that prove that any equipment, process, procedure, material, activity, or system performs its intended functions adequately and consistently, and lead to the predetermined results of uniform batches that meet the required specifications and quality attributes.
Process validation is carried out by using a document plan stating how validation will be conducted, including test parameters, product characteristics, and production equipment and decision points on what constitutes acceptable results. Based on initial formulation development of the drug, critical parameters are identified, which are then optimised and validated.
Validation tests are conducted at each stage during the process and results compared with the benchmarked acceptance criteria. Replication studies are conducted on a minimum of three consecutive batches to ensure validation, precision and repeatability critical in the pharmaceutical industry. We assess existing validation methods, identify gaps if any and deploy suitable improvement techniques for validation success.
Cleaning Validation
Cleaning validation is a technique employed to verify that processes and procedures used to clean the product residue from process equipment and components will consistently and significantly reduce the amount of active ingredients/excipients and cleaning agent to a concentration within calculated acceptance limit.
For the pharmaceutical industry, microbial contamination, residue levels, active ingredient levels, etc. form the core that can determine the success or failure of a drug validation. Therefore, cleaning validation is conducted in accordance with a documented plan stating how cleaning will be conducted, sampling plan, including test parameters, product characteristics, and acceptance limit.
Chemical determination of the previous product is done at ppm levels. Detergent residues are also analysed in ppm level. Additionally, microbial contamination is checked for optimised validation. Precise Analytics Lab. is geared up to be your partner in validation in the pharmaceutical industry.
FAQ's
Specificity, linearity and range, accuracy, precision (repeatability and intermediate precision), limit of detection and limit of quantification, and robustness.
Our development and validation work conforms to ICH, USP and other relevant pharmacopoeial guidelines, and we maintain client-specific protocols where required.
Yes, for pharmaceutical products and bulk drugs. Cleaning validation checks product residue and detergent residue at ppm level, along with microbial contamination.
Replication studies are conducted on a minimum of three consecutive batches to confirm precision and repeatability.
Yes. We assess existing validation methods, identify any gaps and apply suitable improvements to help the validation succeed.
Send an enquiry first. Once feasibility is confirmed and you have our quotation, deliver samples to our laboratory in Wagle Estate, Thane, or ask us to arrange collection.
Yes. Each sample receives a Certificate of Analysis, released only after the report and raw data are verified by the Section Head and QA.
Share your sample details and requirements through our enquiry form. We send quotations by email.
Need accurate, compliant testing for your products?
Share your sample details and requirements. We’ll confirm feasibility, recommend the right analytical approach and send you a quotation.