Processes validation, is a general term for process relevant validation, typically include production process validation and cleaning validation, etc.
The purpose of process validation or continued process validation is to prove that this process can stably produce products that meet the intended use and registration requirements in accordance with the specified process parameters. Manufactures should monitor product quality to ensure that a state of control is maintained throughout the product lifecycle with the relevant process tends evaluated. Process validation is a key factor to ensure product quality and is also a prerequisite for a product to obtain marketing authorization through registration.
The purpose of cleaning validation is to establish reliable cleaning methods and procedures to prevent contamination and cross-contamination of pharmaceutical products during manufacturing. Cleaning validation can reduce the risk of drug cross-contamination and microbial contamination and ensure drug safety. Proper implementation is an important part for passing GMP inspection.
gempex has over 20 years of experience and we have established mature working methods in the cleaning validation projects in China, US, and EU. Our technical consultants can quickly provide customers with the required process cleaning validation services, and finally help them to pass domestic and foreign inspections and audits with high compliance!
International project experience and mature working methods
GMP technical consultants with multi-industry backgrounds
Customizable services - from training to risk analysis, proposal report preparation and validation implementation guidance
1. Process validation
2. Cleaning validation
3. Aseptic Process Simulation/Media Fill
4. Sterilization validation
5. Validation of analytical methods
6. Disinfectant efficacy
7. Cleaning clean clothes
In addition,gempex can providevalidation consulting and training services, we can assist our customer to preparevalidation plans, guidevalidation implementation on-site (flexible choose Chinese and/or Western experts), evaluate implementation orreview, reviewvalidation documents and assist them to prepare reports, etc.
