Despite heavy FDA regulations, problems in GMP manufacturing of dietary supplements arise frequently. Common issues include:
- Inadequate document control – Operators can overlook potential problems or fail to sign off on important processes in real time.
- Confusion in batch records – Missing pages or a missed step can cause an entire batch record to be lost or unusable.
- Paper documents – Reviews and changes are time consuming.
- Logs aren’t updated in real-time – Operators may have to move to different equipment areas and this information may not be recorded.
- Getting approvals and signatures – Approvals for batch records and protocol changes are often left to the end of the process. Locating the individuals needed to sign off on these important documents can be time confusing and frustrating.
How a Manufacturing Execution System Helps
An electronic manufacturing solution such as InstantGMP MES solves many of these issues and paves the way for your facility to become paperless.
- Electronic records are kept in a central location and can be accessed by the necessary staff members via the internet.
- Operating procedures are easily accessible.
- Digital signatures are 21 CFR Part 11 compliant and include a time and date stamp.
- Transcription errors are reduced.
- Reviews are less time consuming.
Request a demo to learn more about how InstantGMP helps dietary supplement manufacturing facilities with GMP compliance!