Validation

What is validation?

Validation is the action of proving, in accordance with the principles of Good Manufacturing Practice, that a specific procedure, process, equipment, material, activity, or system actually leads to the expected results (EU GMP guidelines).

The purpose of validation is not to improve the quality of products or process parameters, increase product yield, or profitability of production but to identify and demonstrate that products are released with an inappropriate degree of assurance and take risk mitigation measures associated with the delivery of products, which quality attributes do not meet specifications, to a customer.

Process validation includes:

Process validation of medicinal products, vaccines, and other immunobiological products, dietary supplements, and medical devices, etc.

Cleaning validation:

Carrying out assessment of risks in cleaning validation, justification of the rationale for selection of the worst-case among test products (that have a similar route of administration, mechanism of action, pharmacological class, etc.);
Calculation of MAC and NOAEL, acceptance criteria for residues based on the limit of the most precise analytical method, etc.;
Relationship between cleaning validation criteria and meteorological characteristics of analytical methods;
Determination of approach to cleaning validation;

Development of validation protocols, elaboration of recommendations on sampling, statistical data analysis, and development of validation reports.

Validation of distributors of medicinal products (GDP validation):

Validation of warehouse facilities, cold rooms, freezers, refrigerator vans, insulated shipping containers, etc.;
Transport and cold chain validation.

Validation of computerized systems:

Computerized systems for monitoring critical parameters of the manufacturing process, storage and transportation of products;
1C:Enterprise-based computerized systems;
MES (Manufacturing Execution System), WMS (Warehouse Management System), ERP (Enterprise Resource Planning System), EMS (Environmental Management System), DMS (Document Management System), BMS (Building Management Systems).

Thanks to their extensive work experience at pharmaceutical companies, special training programs, courses, and experience in the sphere of validation, our specialists may approach the implementation of every new project with any degree of complexity from a professional point of view.

All documents presented comply with the requirements of national and international GMP/GDP standards.

Validation documents:

Validation protocol is a document describing the activities to be performed for testing as well as defining specific parameters to be assessed, acceptance criteria of each of these parameters, assessment criteria, methods of measurement and measuring instruments, including information about their precision, verification and calibration.

Validation report is a document in which the results of completed validation activities, initial information about the validation object, analysis of obtained data, proposals for conducting revalidation and conclusions are assembled.