Process Validation
Cleaning Validation
Analytical Method Validation
Other Validation Services
- TPS Company offers other validation consultation services to support the implementation of all aspect of validation in process based on PIC/S Guideline, Food and Drug Administration, and Good Automated Manufacturing Practice (GAMP), including latest debates and trends.
Process Validation
A process is the controlled interaction of components, equipment, environment, software and personnel to produce a product or achieve an acceptable outcome. The process validation protocol describes a plan that demonstrates consistency and reliability in processing and confirms that all component, processing and product specifications are appropriate and attainable under ideal and challenged conditions. Successful process validation requires thorough process development, identification of controlled and critical parameters and in-process and final product specifications. Typically at a minimum three (3) consecutive lots of product meeting the established quality specifications are necessary for process validation.
TPS Company provides the consulting expertise to demonstrate through appropriate testing that the finished product produced by a specified process meets all release requirements for quality.
Out lines:
- Definition of a Validation Strategy
- Execution of the Validation
Out puts:
- Gap Analysis
- Providing Quality Risk Assessments
- Providing Process Validation Protocols
- Providing Process Validation Report
Analytical Method Validation
We understand that analytical method validation are extremely important in the development of our clients’ products. Analytical methods must be validated to provide reliable data for regulatory submissions. With years of experience, our team gives support to the development of these methods to ensure compliance with quality and safety standards. We have gained confidence with our clients by providing accurate and reproducible results.
The studies involved in TPS’s validation services include:
- Linearity testing
- Precision (repeatability and intermediate precision testing)
- Accuracy
- Specificity
- Limit of detection
- Limit of quantification
- Range of acceptance criteria
- Robustness and stability of test solutions
Out put:
- Providing Analytical Risk Assessment
- Providing AMV Protocol
- Providing AMV Report
Cleaning Validation
The aim of the cleaning validation is to verify the effectiveness of the cleaning procedure for removal of product residues, degradation products, preservatives, excipients, and/or cleaning agents as well as the control of potential microbial contaminants. In addition one needs to ensure there is no risk associated with cross-contamination of active ingredients.
Steps:
- Select and evaluate effective cleaning methods and processes
- Establish residue limits and calculate sample acceptance criteria
- Select sampling and analytical methods
- Simplify the cleaning validation program
- Evaluation of critical risks and calculation of allowed residue levels on manufacturing equipment
- Applying wide range of available techniques: Microbiology tests, Endotoxin Test, HPLC techniques
- Analysis of validation samples (direct surface samples and rinse samples)
Out puts:
- Providing Cleaning Validation Protocol
- Providing Cleaning Validation Reports