PHARMA PLANT VALIDATION SERVICES on the highest level by Rafteikning Bulgaria Ltd. ✓

Preparation and performing of qualification documents and tests as Validation Plan VP, Qualification Project Plan QPP, User Requirements Specification URS, Functional Specification FS, Risk Analysis RA, Design Specification DS, Design Qualification DQ, Installation Qualification Protocol IQP, Operational Qualification Protocol OQP, Performance Qualification Protocol PQP and Qualification Summary (final) Report QSR. All documents are prepared according to GMP (Good Manufacturing Practice) and the GAMP® 5 (Good Automated Manufacturing Practice) Guide.

Performing validation and re-qualification services of pharmaceutical process and lab equipment, HVAC systems, temperature and humidity monitoring systems, mapping of drug warehouses and transport vehicles.

Since 2005.

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. For this reason validation is a key part of drug manufacturing.

 


Additional information about the engineering services provided by Rafteikning Bulgaria Ltd. in pharmaceutical plant validation of process equipment can be obtained by contacting us.