Validation of Pharmaceutical Processes, Raimon Group
Pharmaceutical Process Validation: A CGMP
Concept Summary:
Validation of the most known and most important GMP parameteris This article provides an introduction to the process validation of the drug manufacturing process and its importance according to the United States Food and Drug Administration (FDA) . This work is to provide an introduction and overview of the process validation of the drug manufacturing process. Cannot be guaranteed by sampling, testing, release of materials and products. Quality assurance techniques must be used to establish quality in the product at every step, not just testing at the end. Process validation of a drug manufacturing process with reproducible quality. In the pharmaceutical industry, the validation process performs this task to establish quality in the product, because according to the ISO 9000:2000 standard, proved to be an important tool for quality management of medicines.
Introduction
Concept validated for the first time by two FDA officials, Ted Byers and Bud Loftus, was introduced in the mid-1970s to improve the quality of drugs. The first validation activities focused on processes related to the manufacture of these products, but quickly expanded to related processes including environmental control, media filling, equipment cleaning, and treated water production.
In a manual, validation is the practice of demonstrating and documenting that any procedure, process, or activity consistently leads to expected results. This includes qualification of systems and equipment. The goal of validation is to ensure that quality is built into the system at every stage, and not just tested at the end, as such validation activities typically include training on manufacturing materials and operating procedures, training of those involved, and monitoring of The system during production generally verifies an entire process and a specific object in that process. Regulations also expect that different parts of the production process are well defined and controlled, so that the results of that production do not change substantially over time.
Introduction to Pharmaceutical Validation:
Aromatization of pharmaceutical processes is a concept that has been continuously evolving since its first informal appearance in the United States in 1978. However, validation concepts were first introduced by Ted Byers and Bud Loftus in the mid It was introduced in the 1970s to improve the standard of prescription drugs. The first validation activities targeted the processes involved in the creation of these products. However, they were quickly exposed to related processes and environmental management, media filling, equipment cleaning, and pure water production.
According to the guidelines, validation is the practice of demonstrating and documenting any procedure, process, or activity that can systematically produce expected results. This includes the qualification of systems and equipment. The purpose of validation is to confirm that quality is maintained at each step and is not merely tested at the last step according to the validation process.
The importance of validation in pharmaceuticals
Validation plays an essential role in pharmaceuticals in the following cases:
Quality Assurance: In daily routine, product quality cannot be guaranteed by testing due to the limited availability of samples and final product testing.
To reduce cost: due to the reduction in the number of sampling and testing procedures in the validation process, less product rejection and retesting leads to cost reduction. If it works according to the manufacturer's specifications, the life of the equipment will be longer.
Compliance: Validation according to cGMP complianceIt is essential.
Why validation is a process:
The main reasons for validation are:
1. Quality assurance: Due to the limitations of statistical samples and the limited facilities of final product testing, quality cannot be guaranteed by daily quality control testing. Validation examines the accuracy and reliability of a system or a process to meet predetermined criteria. A successful validation provides a high degree of assurance that a consistent quality level is maintained in each unit of the final product from batch to batch.
2. Economy: due to successful validation, the sampling and testing process is reduced and the number of product rejects and retests is less. This leads to cost saving benefits.
3. Compliance: To comply with current CGMP Good Manufacturing PracticesValidation is essential.
Head of department:
- SVC Site Validation Committee: Development of the main validation plan of the site, preparation/implementation/confirmation of validation studies
- Production Department: Prepares batches as a normal production batch
- Quality Assurance: Ensure compliance, see that documentation/procedures are in place, validate protocols and reports.
- Quality control: testing and checking the protocol and report if needed.
Officials responsible for validation:
The Validation Working Group is formed to define progress, coordinate and ultimately approve the entire effort, including all documents produced. The work group usually includes the following employees, preferably people who have good insight into the company's performance.
- Head of Quality Assurance
- Head of Engineering
- Validation manager
- production manager
- Field of specialized validation: all fields
- Section / Designation
- Responsibility
- production manager
- Responsible for creating categories and reviewing protocols and reports.
- Quality control management
- Responsible for analyzing samples
- Collected
- executiveQC
- QC responsible for sample collection and submission to
- Maintenance manager
- Providing urban and engineering services
- Support
- Executive production
- Responsible for preparing the protocol and building validation categories
- Quality management
- Responsible for protocol authorization and preparation of summary report.
Validation elements:
Qualification is a prerequisite for credit. Eligibility includes the following:
1. DQ design qualification:
In this qualification, design compliance with GMPmust be shown. The principles of design should be such that the objectives of GMPFind out about the equipment. Mechanical drawings and design specifications provided by the equipment manufacturer should be reviewed.
2. IQ installation qualification:
Installation qualification must be done on new or modified installations, systems and equipment. The following main points should be included in the installation qualification.
- Checking the installation of equipment, piping, services and instrumentation.
- A set of supplier operating instructions and their maintenance and calibration requirements.
- Approval of construction materials
- Spare resources and maintenance
3. Operational Qualification of OQ:
Operational competence should be of IQto follow, OQIt should include the following:
Tests developed from knowledge of process systems and equipment. Definition of lower and upper operating limits. Sometimes, these conditions are called "worst case".
4. PQ performance qualification:
After completing IQand OQ, the next qualification to be completed is PQIs. PQIt should include the following:
Tests using manufactured materials, substitutes or simulated product. These can be developed from process knowledge and facilities, systems or equipment.
Experiments to include high and low bound conditions
Process Validation:
US Food and Drug Administration FDA has proposed guidelines with the following definition for process validation:
Process validation is the creation of documented evidence that provides a high degree of confidence that a particular process (such as the manufacture of pharmaceutical dosage forms) consistently produces a product with its predetermined quality specifications and characteristics.
According to the FDA, assurance of product quality results from careful and systematic attention to a number of important factors, including: selection of quality components and materials, appropriate product and process design, and process-by-process (statistical) control. and final product testing. Therefore, it is through careful design (qualification) and validation of both the process and its control systems that a high degree of assurance can be established that all individual production units of a given batch or sequence of batches meet the specifications. They will be acceptable.
This guide describes process validation activities in three steps.
Stage 1 - Process Design: The commercial production process in this stage is defined based on the knowledge gained through development and scale-up activities.
Step 2 - Process Qualification: During this step, the process design is evaluated to determine if the process is capable of repeatable commercial production.
Step 3 - Continuity Process Verification: Continuous assurance is obtained during routine production that the process remains in control.
Types of process validation:
1. Future Validation: It is the creation of documented evidence of what a system does or what it claims to do based on a program. This validation is done before the new product is distributed.
2. Retrospective confirmation:
Validation master plan:
It is important to prepare a summary document that describes the entire project. Developing a "Validation Master Plan" ( VMP ) has become a common practice in the industry. This document usually covers the qualification aspects of a project.
Validation Protocol:
After the VMP is preparedThe next step is to prepare the validation protocol. The following are the contents of a validation protocol.
1. General information
2. Purpose
3. Pre-accreditation background activities A summary of R&D development and technology transfer activitiesor other sites) to justify in-process tests and controls. Any prior validation
4. List of equipment and their qualification status
5. Qualification of the facility
6. Process flow diagram
7. Narration of the production procedure
8. List of critical processing parameters and critical excipients
9. Sampling, testing and specifications
10. Acceptance criteria
Tablet manufacturing process overview:
process step, typical variables and responses during the tablet manufacturing process validation process
Conclusion:
From the study, it can be stated that process validation is a main requirement of cGMP regulationsIt is for final pharmaceutical products. This is a key element in ensuring quality objectives are met. Successful validation of a process may reduce dependence on intensive testing of both the process and the final product. Finally, it can be concluded that process validation is a key element in pharmaceutical product quality assurance because final product testing is not sufficient to ensure final product quality. 
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