Data integrity is essential in the pharmaceutical industry to ensure products’ quality, efficacy, and safety. In today’s modern generation, pharmaceutical companies use computers and automated systems for generating data. With this, regulatory bodies require companies to comply with data integrity. Meanwhile, in this post, we will discuss data integrity SOP.
What is SOP?
SOP stands for Standard Operating Procedures. It is a written procedure of any system or process followed on an equipment or system operation. SOPs in the pharmaceutical industry is essential for quality control, quality assurance, utility, maintenance, production, and human resource.
Why is data integrity SOP necessary?
Data integrity SOP is vital to ensure public health. It is also beneficial to ensure that the pharmaceutical products are safe, quality, and effective. With the help of data integrity SOP, pharmaceutical companies can also improve their data security.
Practicing data integrity also helps to establish trust between the companies and regulatory agencies. It removes the requirement for inspecting each process in the supply and production of drugs and other pharma products.
Data integrity SOP features
When it comes to data integrity SOP, the data should have the features below:
The data should be offered in an understandable way and should be kept in general language.
It should be free from automated or human errors.
The data should be contemporary and fits the place’s time zone.
The data should be plagiarism-free and original.
It should be reflective, complete, and truthful.
How to integrate data in the pharmaceutical industry?
Companies can integrate data through the following ways:
Data should be stored safely to avoid deterioration, loss, and theft.
Data should be safe, and no one is allowed to delete, modify or disturb it.
Data should record a complete assessment of the performed test without failure to record anything.
Data should be maintained in original records, true copies, and accurate reproductions with credits.
Standard Operating Procedure (SOP) outlines the Handling of Data Integrity Observations procedure to ensure that observations are documented, identified, concluded, and investigated properly with the implementation of preventive/ corrective actions that can reduce or eliminate chances of similar issue recurrence.
Important considerations for data integrity
Data integrity should be kept in manual or system-generated electronic data. The data needs to be accurate and complete without alterations. If there are identified data integrity issues, they should be handled by the quality management system and the right corrective and preventive action for risk assessment.
The data should be approved and verified by an expert technical person. Data should adhere to ALCOA rules: attributable, legible, contemporaneous, original, and accurate. It also needs to be complete and readable. Instruments with audit trials need to be reviewed daily before data approval. Additionally, it should be checked for any abnormality.
Proper training on data usages and the integrity of computer systems need to be provided to all responsible personnel. Date integrity SOP is also important in the pharmaceutical industry to comply with the regulatory requirements.
Data integrity SOP helps provide accurate, complete, and consistent data in the pharmaceutical industry to sum it up. It helps to comply with the regulations, recalling products, and enhancing the reputation of a company in the industry.