Qualification and validation

When launching a new production process, in accordance with international standards of good manufacturing practice (GMP) and the decision of the Council of the Eurasian Economic Commission of November 3, 2016 N 77 ""On the approval of the Rules of Good Manufacturing Practice of the Eurasian Economic Union"" a special role in quality assurance is given to the qualification of equipment involved in this production process.

Equipment qualification is a set of checks with subsequent documentation of the results, aimed at confirming that the equipment is installed and functioning properly and ensures reproducibility of the results.

There are several stages of qualification, which are carried out sequentially. Each stage has its own testing focus and cannot be performed without the previous ones.

There are several stages of qualification for new equipment:

DQ (Design qualification) – project qualification. A set of checks carried out at the stage of development and approval of the project, confirming that the project meets the requirements of the user (URS - User requirement specification) and GMP requirements.

IQ (Installation qualification) – installation qualification is aimed at verifying the correctness of the installation of equipment at the place of operation. The completeness of the delivery, the provision of operational conditions, the proper supply of media and power supply, the correctness of the documentation supplied with the equipment (diagrams, drawings, etc.), verification of certificates of conformity of materials and the availability of calibrations of measuring instruments are checked.

OQ (Operation qualification) – operation qualification confirms that the functionality of the equipment and the logic of operation meets the requirements of the user specification and GMP requirements.

One of the most important parts of the equipment qualification process is the accompanying documentation:

URS (User requirement specification) – specification of user requirements. A document intended for the formulation of requirements for the project. It should include both basic information (purpose of the equipment, materials of manufacture, performance) and describe the process-critical algorithms for the operation of the equipment. The more detailed this specification is, the less likely it is that defects will occur during the implementation of the project.

FDS (Functional Design Specification) – functional specification of the project. This document describes the logic of the equipment and technical solutions to the tasks set at the stage of drawing up the requirements for the project.

HDS (Hardware Design Specification) – hardware specification. A document describing the hardware architecture of the equipment - a description of the components and how the connection between them is implemented.

SDS (Software Design Specification) is a software specification. A document describing the implementation of hardware software (description of user interfaces, specified development environment, communication protocols, etc.).

QPP (Quality Project Plan) - The main purpose of QPP is to provide a systematic and complete overview of the work that needs to be done throughout the project implementation to ensure that the equipment meets the requirements of URS and legislation.

Based on this, the QPP document is aimed at:

·           Carrying out unambiguous identification of equipment subject to qualification

·           Definition of the organization and responsibilities of personnel involved in the qualification process

·         schedule a qualification task, putting priorities on the level of criticality

·              Defining the qualification strategy by showing the stages of the qualification process and documentation related to the project, and establish a procedure for handling inconsistencies

· Defining the qualification matrix by setting the code for the qualification protocols to be performed and specifying for each of them the tests to be performed

·                     Defining a change management strategy, maintenance, calibration and training, if applicable

QPP also aims to facilitate the presentation of the project during any audit or inspection by providing a clear picture of the work performed on the new equipment, as well as the chosen method and form of documentation.

FRA (Functional Risk Assessment) – The purpose of functional risk assessment is to assess user requirements (URS) in relation to GMP requirements and Decision No. 77, as well as to identify corrective actions or implement controls to reduce the identified risk.

It is worth highlighting the measures for the re-qualification (RQ) of equipment already in operation, which is carried out when changes are made or after a certain period of time.

To carry out the requalification, it is necessary to determine the critical functions and components of the equipment or to establish the functions and nodes affected by the change and draw up a verification protocol in accordance with the analysis.

Our services:

·        Assistance in drawing up the specification of the customer's requirement (URS)

·          Conducting functional risk analysis (FRA)

·           Drawing up specifications (FDS, HDS, SDS)

·        Development of a Project Quality Assurance Plan (QPP)

·            Conducting and developing project qualification protocols (DQ)

·           Conducting installation qualification (IQ)

·        Performance Qualification (OQ)

·           Equipment requalification (RQ). The scope of testing is agreed personally