Document retention is essential for quality assurance systems in the pharmaceutical industry. It helps to avoid errors in spoken communication. In addition, document retention helps to trace the performed activities. Companies should comply with regulatory requirements when it comes to document retention.
How long does a document retain?
Documents and records should be completed to trace significant activities in the manufacturing of pharmaceutical products. Documentation is necessary for facilitating a recall of a batch if needed.
Records and documents need to be retained for at least one year after the finished product’s expiry date. The manufacturer of pharma products should have a documentation system based on manufacturing formulae, specifications, records, and procedures regarding different manufacturing operations.
Why is document retention important?
Document retention in the pharmaceutical industry is essential for the following reasons:
Retaining documents can offer legal evidence that a company complies with GMP.
Testing and manufacturing documents (with product retention samples) remain if a batch was released.
These documents can be real information sources on a released batch, so they need to be complete and accurate.
Document retention is beneficial for the investigation of adverse events/ product complaints.
In cases of legal dispute, the GMP-related documents can be used to verify that the company complies with GMP.
Usually, product history and production need to be monitored for trends. It can be done if the documents are complete and accurate.
Rules in document retention
Document retention in the pharma industry should follow these rules:
Documents need to be legible and accurate. They must be completed in real-time and should be stored to prevent destruction or loss. In correcting the date, cross the incorrect data using one line, enter the new data, initial or sign it, and date it. It is not advisable to use erasers or whiteouts in document retention.
Documents need to be signed, approved, and dated by an expert or authorized person. They also need to be prepared, designed, reviewed, and distributed carefully. The documents need to have unambiguous contents. It must state clearly the title, purpose, and nature of the document. More importantly, the retained documents should be reviews and maintained up to date regularly.
It is essential that on the retention period, the documents are legible at the right time. If the data is modified, it can be traceable.
Audited documentation systems
The following are documentation systems that need to be audited regularly:
- Equipment cleaning, assembly, and use log.
- Control records and master production
- Drug product container, components, closure, and labeling records
- Control records and batch production
- Production record review.
- Complaint files.
- Distribution records.
- Laboratory record systems such as analytical methods and electronic data systems.
- Annual product reviews.
- Maintenance records and equipment calibration.
- Training records.
- Environmental monitoring records and more.
Document retention is important in the pharmaceutical industry to avoid improper use of data. It also helps to ensure that the company complies with the regulatory requirements.
Generally, document retention should have a schedule on various document types. Documents related to manufacturing should be retained a minimum of one year after the product’s expiration date. On the other hand, the validation documents not specific to batches can be kept longer.