PROCESS VALIDATION

Process validation is a systematic, documented process that ensures equipment, processes, materials, and systems perform consistently and achieve the intended results, producing uniform batches that meet quality standards and specifications.

It involves a detailed validation plan outlining test parameters, product characteristics, production equipment, and criteria for acceptable outcomes.

In the pharmaceutical industry, process validation is critical to the validation cycle. Starting with initial drug formulation development, critical parameters are identified, optimized, and validated.

Validation tests are conducted at each stage, with results measured against established acceptance criteria. To ensure precision and repeatability, replication studies are performed on at least three consecutive batches.

At ShreeHari Testing Lab, we evaluate current validation methods, identify gaps, and implement effective improvement strategies to ensure validation success in the pharmaceutical industry.

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION

Analytical method development and validation are critical in the pharmaceutical industry to ensure accurate, reliable, and reproducible results. At ShreeHari Testing Lab, we provide regulatory-focused, phase-appropriate, and sample-specific solutions tailored to pharmaceutical validation and method development.

Our processes align with regulatory standards outlined in ICH, USP, and other pharmacopeial guidelines while adhering to client-specific protocols. Leveraging advanced analytical technologies, expertise in chemicals and pharmaceuticals, and a deep understanding of regulatory practices, we deliver sensitive, precise, specific, and accurate results.

We specialize in developing and validating analytical methods for chemical and pharmaceutical procedures.

- Specificity
- Linearity and Range
- Accuracy
- Precision

- Repeatability
- Intermediate Precision
- Limit of Detection and Limit of Quantification
- Robustness

We provide analytical method development services, including process and cleaning validation, for pharmaceutical products and bulk drugs.

CLEANING VALIDATION

Cleaning validation ensures that cleaning processes effectively and consistently reduce product residues, active ingredients, excipients, and cleaning agents to acceptable levels within calculated limits.

In the pharmaceutical industry, factors such as microbial contamination, residue levels, and active ingredient traces are critical to the success of drug validation. Cleaning validation follows a documented plan outlining cleaning procedures, sampling methods, test parameters, product characteristics, and acceptance criteria.

Residues of the previous product and detergents are analyzed at ppm levels, while microbial contamination is assessed to ensure optimized validation.