In pharmaceutical and modern projects, due to the sensitivity of the project to the acceptance of global standards, it needs to be tested and qualified. (qualification) At all stages of project life (Project Life cycle) From the beginning of the design phase to delivery.
Accordingly, participation in this type of project in addition to testing devices at the factory (FAT) Together with the representative of the employer and the manufacturer, he performs various tests of devices and lines so that the problems of the lines, if any, can be identified and resolved before shipment.
quality and validation
Validation And GMP Our specialty validation And GMP Design and construction of projects and Pharmaceutical factories Human and animal, medical and food equipment in accordance with GMP principles validation And GMP design and manufacture of human and animal pharmaceutical projects and factories
, Medical, Cosmetic and Food Equipment in accordance with EU GMP principles (PICS) , FDA and WHO are our specialties. The most important thing in carrying out any project, especially in the above projects, is to observe the standards and validate them in order to meet the requirements..
The companys specialists have received the necessary training in all standards inside and outside the country and have sufficient experience to design and deliver projects based on the required requirements and help you to obtain approvals from relevant organizations such as the Ministry of Health, Medical Education and Veterinary Organization. Will do .
The company also has the necessary equipment and knowledge Validation (validation) This type of project has from design phase to delivery. We are proud to be the first Iranian company to have experienced specialists in the field of pharmaceutical engineering and accreditation for the first time. (validation) We provide and provide validation and qualification services in the pharmaceutical industry. We are proud to be the first and only Iranian company to provide validation services. (validation) Professionally and in accordance with the standards ( ، GXPEU ، FDA ) We offer the country.
If in design and qualification Production lines and pharmaceutical factory And you have a problem with medical equipment, either in order to validate the process, manufacturing, production and equipment, methods and other parts of pharmaceutical products, or in the construction and validation of installation systems and clean rooms to meet the requirements. ( GXPEU ، FDA ) And you are approved by the competent authorities, consult with us. Our specialists are fully trained and fluent in all new concepts so that your factory and production plant can be validated from the beginning of the design phase to the end and with the requirements. (،GXPPICS , US FDA) Deliver.
the part Quality assurance and validation
Company with engineering department, especially unit Validation Pharmaceuticals and quality engineering are able to plan and perform the following activities: Design, implementation and documentation of quality systems using the combined method of ISO and G systems(X=L,M,D) P to perform activities Validation is.
quality and validation
quality and validation GMP is our specialty validation و GMP Design and construction of human and animal pharmaceutical projects and factories, medical and food equipment in accordance with the principles of GMP validation and GMP Design and construction of projects and human and animal pharmaceutical factories, medical, cosmetic and health and food equipment in accordance with EU GMP principles (PICS) , FDA and WHO are our specialties. The most important thing in carrying out any project, especially in the above projects, is to observe the standards and validate them in order to achieve the required. The companys specialists have received the necessary training in all standards at home and abroad. . The company also has the necessary equipment and knowledge
Validation
This type of project has from design to delivery.
We are proud to be the first and first Iranian company to have experienced specialists in the field of pharmaceutical engineering and accreditation. (validation) We provide and provide certification and qualification services in the pharmaceutical industry. We are proud to be the first and only Iranian company to provide certification services.(validation) Professionally and in accordance with standards ( ، GXPEU ، FDA ) We offer the country.
If you have problems in designing and qualifying production lines and pharmaceutical factories and medical equipment, or in order to validate the process, manufacturing, production and equipment, methods and other parts of pharmaceutical products, or in the construction and validation of installation systems and Clean room To meet the requirements (GXPEU ، FDA) And you are authorized by the competent authorities to consult with us. Our specialists are fully trained and fluent in all new concepts so that your factory and production plant can be validated from the beginning of the design phase to the end and with the requirements. (GXPPICS,ME,FDA) Deliver. The quality assurance and validation department of the company together with the engineering department, especially the pharmaceutical validation unit and quality engineering, is able to plan and perform the following activities:
Design, implementation and documentation of quality systems using a combination of systems ISO and G(X=L,M,D)P and perform validation activities (quality and validation)
(Validation) From the beginning of the project design to the end, as in the following cases, it is not limited to doing so:
Creating documented and reasoned documents
For quality and validation, in order to prove a process, instruction, or activity, it continuously produces products with a high degree of guarantee in accordance with predetermined quality characteristics.. In the pharmaceutical industry, in addition to the final inspection and testing of products, it is very important to make sure that a process continuously and consistently produces the desired results.. Optimal output results are defined as specifications.
Qualification
Hence the evaluation or qualification of systems or equipment as part of the process Validation Is. Validation for industries and food companies, pharmaceuticals and pharmaceutical legislation agencies such as US,FDA and guidelines (guidelines) جیامپی Is a requirement. Since there is a need to validate a large volume of processes, procedures, and activities, the validation branch is subdivided into the following sub-categories::
Validation Equipment
Validation of facilities
HVAC system authentication
Validate the cleaning process
Validation Process
Validation of analysis methods
Computer system authentication
In the same way, the validation process (quality and validation) Its systems and equipment are divided into several sub-branches:
DQ design validation (Design qualification)
Validation of CQ components (Component qualification)
IQ validation (Installation qualification)
OQ validation (Operational qualification)
PQ performance verification (Performance qualification)
Comprehensive validation plan (Validation master plan)
Comprehensive validation plan to English: Validation Master Plan is a document that describes when and how a validation plan in a factory (facility) Must be implemented. Although this is not mandatory, the document outlines the general principles of factory evaluation, along with the areas and systems to be evaluated, and provides a written plan for achieving and maintaining a qualified plant with approved processes.. This document is the foundation of the accreditation program and should include process validation, factory and facility evaluation and validation, equipment evaluation, cleaning process certification, and computer system.. Rules usually expect the different components of a production process to be well defined and controlled, so that production results do not change significantly over time.
Validation process
Conventional evaluation process
The scope of accreditation, the boundaries and tasks of each process or group of similar processes or equipment, must be approved and documented in a “validation plan”.. These documents, terms and references are used for protocol authors to determine the scope of the protocols.. This should be based on a Risk Assessment Validation To English: Validation Risk Assessment (ASK) To ensure that the approved validation range is appropriate for the complexity and importance of the equipment or processes being validated.. Assessment (Qualification) Includes the following:
Design evaluation (DQ) –
Indicates whether a design is provided (Or an existing design for products that have already been produced) All requirements defined and in the document “User requirements specifications” Or “(URS) User Requirements Specification”, Will fix the existing one or not. Successfully resolving DQ requirements is essential before starting to build a new plan that is to be evaluated.
Installation evaluation (IQ) –
Indicates that a process or device has all the specified specifications, is properly installed, and all the components and documents required for its continuous operation are available and installed..
Operational evaluation (OQ) –
It shows that all the elements of a process or device are working properly.
Performance appraisal (PQ) –
Indicates that a process or device is working over time as intended.
Evaluation of components (CQ) –
The term is almost new and was defined in 2005. This term refers to the construction of auxiliary components (auxiliary components) This is to ensure that these components are made to the correct design criteria. These include items such as packing components such as cartons, shipping packages, labels and even changing the material phase.. All of these components must be inspected randomly to ensure that the processes of third-party companies continuously produce products that are used in the GMP world of the pharmaceutical and biological industries..
Although these are defined separately, PQ and OQ may need to be performed continuously in some cases..
