PHARMA PLANT VALIDATION SERVICES on the highest level by Rafteikning Bulgaria Ltd. We prepare and execute qualification documents as Validation Plan VP, Qualification Project Plan QPP, User Requirements Specification URS, Functional Specification FS, Risk Analysis RA, Design Specification DS, Installation Qualification Protocol IQP, Operational Qualification Protocol OQP, Performance Qualification Protocol PQP and Qualification Summary Report QSR. Performing validation and re-qualification services of pharmaceutical process and lab equipment, HVAC systems, monitoring systems, drug warehouses and transport vehicles mapping.

Since 2005. 

Rafteikning Bulgaria Ltd. 

 

 

Rafteikning Bulgaria

Pharmaceutical validation ✓ Reasons

FDA, BDA (Bulgarian Drug Agency) or any other food and drugs regulatory agency around the globe not only ask for a product that meets its specification but also require a process, procedures, intermediate stages of inspections, and testing adopted during manufacturing are designed such that when they are adopted they produce consistently similar, reproducible, desired results which meet the quality standard of product being manufactured, such procedures are developed through the process of validation. This is to maintain and assure a higher degree of quality of food and drug products. Validation is Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient evidence that every product within a batch meets the required specification validation is major parts of drug manufacturing.

 


Additional information about the engineering services provided by Rafteikning Bulgaria Ltd. for pharmaceutical plant validation of process equipment can be obtained by contacting us.
Допълнителна информация относно предоставяните от "Рафтекнинг България" ЕООД инженерингови услуги по валидиране на процесно оборудване в производството на лекарства може да получите, като се свържете с нас.