Pharmaceutical facilities consist of various processes like calibration, validation and qualification. All these processes need to follow the FDA guidelines without fail. However, apart from these processes, there has been an increased focus on data integrity which has become important during audits.
Validation is a systematic approach where it is confirmed that any process in a pharmaceutical facility will operate within the specified parameters whenever required. You can achieve validation by collecting and analysing data. Pharmaceutical validation is done to assure that the processes produce consistent and repeatable results within the predetermined specifications.
Equipment validation is critical in every industry. Since every pharmaceutical plant has an IT system which controls, supports and documents various processes, you must validate the computer and IT systems to ensure all the IT applications are fulfilling their intended purposes.
Computer system validation helps in controlling different phases of development, design, testing and routine of the software that is being used by the IT system during its life cycle. If the computer system is running accurately, you can be sure of the information and reports staying safe.
Data integrity
Data integrity is absolutely critical in the pharmaceutical industry to make sure that the end products meet all the required quality standards. Essentially, it is a process of maintenance and assurance of accuracy and consistency of the data over its entire life cycle.
Data integrity is critical to the design, implementation and usage of any system that stores, processes or retrieves important data. If the integrity of the data you collect and record is not maintained, there would be no way to ensure that you are producing high quality and safe products. In order to maintain the integrity of data, you must protect it from accidental or intentional modifications, duplication, deletion and falsification.
Of late, pharmaceutical data integrity has been gaining a lot of importance. Any violations concerning data integrity would lead to several regulatory actions like warning letters and alerts that are issued by the FDA. Since a lot of international regulatory agencies are focusing on data integrity, the FDA, MHRA and WHOA auditors are being trained to recognise data integrity issues in a better way.
The second reason why data integrity is being emphasised in the pharmaceutical industry is because of the increased use of mobile devices in the calibration processes. It also applies to the documenting calibrators that can automatically store the calibration results in their memory during a calibration and while transferring this data to calibration software.
Data integrity can be defined as the degree to which all the electronic, paper-based or hybrid based data are complete, accurate and consistent throughout the lifecycle of the data. The data integrity standard of regulatory bodies is ALCOA whose elements include:
A: Attributable to the person system or device generating the data – All the captured information should identify the source of the data and record any changes made in an accurate manner.
L: Legible and permanent – The data must be recorded and stored in a durable medium that will ensure readability for the full period of time that the data might need to be accessed or referenced legally.
C: Contemporaneous – The data has to be recorded as the data is generated or at the time an event is observed.
O: Original record – There must be a true copy of the data. You must use or present the data as it was created.
A: Accurate – The data must be verified that it is free of errors. The accuracy of the data has to be demonstrated as correct through repeatable calculation, algorithm or analysis.
FDA’s requirements for data integrity
- The data must be secure from alteration, loss or any kind of inadvertent erasure. It should be ensured that even the backup data is exact and complete.
- The data should be stored to prevent loss or deterioration.
- Various activities must be documented at the time of performance and the laboratory controls should be scientifically sound.
- Records should be retained as original records, true copies or other accurate reproductions of the original records.
- The metadata should be stored throughout the record’s retention period.
The data should record complete information. There should be a complete record of all data from all the tests performed and no test or data should be failed to record.
Impact of data integrity breach
Breach of data can be intentional or accidental – the impact of both affecting the company and its customers in numerous ways:
- The company will receive a warning letter from the FDA and their license to produce may be canceled. The pharmaceutical company’s market share will drop and be affected by the negative reputation, thus resulting in low customer satisfaction.
- The customers will suffer if they don’t receive the effect of the medicine and a low quality product could even put their health and safety at risk.
- It is critical that the companies strictly follow the rules for validation and data integrity and adhere to all the stringent guidelines of FDA and other regulatory bodies.
Edward Simpson works for RS Calibration Services
