The United States Food and Drug Authority (FDA) has made it mandatory that all life sciences companies validate Good Manufacturing Practices (GMP) systems and processes into their companies. While it is clear that all companies dealing in pharmaceutical and life sciences products need to comply with the regulatory requirement, the FDA has not detailed any specific methodology for fulfilling this regulatory compliance.
The FDA allows the pharma companies to justify their systems validation approach as long as the software is adequately documented and tested. The regulatory compliance makes it mandatory for pharma companies to go for SAP validation.
The following are the primary reasons why there is a need for SAP validation in pharma companies.
Quality control
Pharmaceutical companies produce medicines that affect human health directly. Therefore, any mishap in the automated production process can have serious consequences. SAP validation ensures that the manufacturing process is safe and hygienic.
Regulatory compliances
Pharma regulators like the U.S. FDA conduct regular inspection checks to ensure that best practices are followed in the production of medicines. SAP validation comes under the ambit of good manufacturing practices and needs to be taken seriously.
Upgradation
The government regulations, manufacturing technology, and evolving field of life sciences are the constantly changing dynamics of the pharma sector. To succeed as a pharma company, you need to stay ahead of all the constant changes that the pharma industry goes through. SAP validation is an essential tool that helps you remain upgraded according to the changing dynamics of the pharmaceutical industry.
What is GAMP5?
To validate their computer systems, most US-based pharma companies have chosen to use the ISPE (international society for pharmaceutical engineering) approach. The approach selected by ISPE is known as the Good Automated Manufacturing Practices 5 (GAMP 5) approach. The pharma companies have chosen GAMP 5 guidelines for computer system validation as a foundation for their validation efforts.
In a nutshell, GAMP 5 is a set of guidelines that provides pharma companies with a risk-based approach to computer system validation. In the GAMP 5 approach, a computer system is evaluated and assigned to a category based on its complexity and intended use. According to the FDA, categorization helps to write robust system documentation, a prerequisite for pharma companies.
Below is the v-model diagram that summarizes the GAMP 5 approach
Here’s what each step represents:
- User requirement specifications: In this step, the user requirements are specified.
- Functional specifications: A user-friendly document is created in this step based on the user requirement specifications.
- Design qualification: In this step, we define the requirements for computer systems. We prepare a document that outlines all the approved and reviewed system specifications.
- Installation qualification: in this step, we ensure that hardware, as well as software installation aspects, are in accordance with the approved codes and designs.
- Operation qualification: We check for the system’s operational capability to ensure that the entire system works as intended.
Performance qualification: This step and sure that all the system components will perform under all operating conditions.
What is included in CSV?
The Computer System Validation (CSV) to verify whether the computer systems are working correctly or not. The gamp 5 CSV method requires detailed documentation of the computer systems used by the pharma company for manufacturing medicines.
The documentation involves…
- Hardware required to support the SAP system
- Functional specifications about the requirement
- List of total hardware required
- Test results with feedback
Benefits of CSV (computer system validation) in the Pharmaceutical Industry
Computer system validation for gamp 5 brings the following benefits to the pharma sector.
Using CSV, you can establish a fixed order of manufacturing and distributing your medicines and medical devices.
- CSV helps you handle unexpected complications.
- CSV reduces your compliance risk.
- CSV helps you detect the errors in the system before it goes live, allowing you to avoid loss.
- CSV helps you with continuous improvement in your process.
- CSV reduces the possibility of a piling tech debt.
- CSV maximizes the system efficiency.
Why Choose Sondagar?
At Sondagar, we have established ourselves as one of the premier consultants that accomplishes SAP validation using GAMP 5. In addition, we have partnered with many companies in the pharmaceutical sector and have helped them with their GAMP 5 implementation.
We provide the following consultancy Services:
CSV audit
We conduct a comprehensive CSV audit according to international requirements. We can prepare an audit that will test the readiness of your pharmaceutical plant for an FDA audit. We can also conduct a subject-based readiness analysis.
CSV strategy
Our expert consultants will prepare an appropriate CSV strategy tailored to your processes. We strictly follow all the GAMP 5 guidelines for computer system validation. We will start by identifying the technical and organizational measures that will be needed to add to your requirements.
We will take your employees into the loop and develop a validation strategy that will fulfill the authorities’ requirements and your customers. We will build a strategy that meets your requirements and helps you economically implement the computer system validation.
CSV implementation
We have CSV consultants that have years of experience validating computerized systems. We will help you in CSV implementation of laboratory, IT, and automation systems. Our experts know the pitfalls that can lead to faulty CSV implementation. So avail of our expertise and avoid your competitors’ mistakes in SAP validation using GAMP 5.
Get in touch with us to schedule a free consultation today!