Good Manufacturing Practice (GMP) is primarily about consistency. It is ensuring that each batch of medicine is produced with the same amount of care and quality. It encompasses all aspects, including the sourcing of materials, maintenance of equipment, and employee training.
However, the pharmaceutical manufacturing industry is developing so fast. New technologies and constantly changing regulations can be challenging to keep up with. But do not worry. Here are five effective measures to ensure your GMP compliance.
Evaluate your standard operating procedures continuously
Even the best SOPs can become outdated. A document that was fit-for-purpose two years ago may no longer meet new regulatory expectations.
Therefore, you should plan a regular review. This should be at least once per year. Make them associate with significant events, like the introduction of a new product, the upgrade of equipment, or the audit results.
Also, engage individuals who are involved in the actual work. Their input can reveal minor differences in the processes that corporate-level analysts may fail to notice.
Enforce data integrity in the source
The regulators are closely monitoring the principle of ALCOA+, which means:
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate.
It is best to incorporate integrity into the data collection process rather than attempting to correct it later. Here is how:
- Automate instruments and systems to record data and not to depend on manual entries.
- Limit access of users and use electronic signatures where necessary.
- Periodically perform data integrity audits: not of systems, but of behaviors.
When you can prove that data is trustworthy at the point of creation, then you are already ahead of most compliance challenges.
Use pharmaceutical manufacturing software for real-time control
Spreadsheet recordkeeping and manual tracking cannot keep up with contemporary GMP requirements. You can significantly reduce risks with an integrated pharmaceutical manufacturing software.
Such systems promote workflow logic, prevent missing steps, and automatically call out deviations or out-of-spec results. You can even link the software with your quality management system (QMS). It offers one source of truth on key processes like:
- Batch data
- Training records
- Equipment calibration logs.
This leads to quicker investigations and cleaner audit trails. However, configuration is important. Don’t digitize bad paper processes. Plot your process flow, then create a digital system to support GMP behaviors, not just for data storage.
Address change control
Most of the compliance holes arise when changing things like:
- A new API source
- Equipment upgrade
- A change of personnel.
Luckily, you can enhance the process of change control. Enforce cross-functional impact assessment before implementation. Categorize changes based on their impact on the product. Then, scale up your documentation and verification accordingly.
Develop a proactive quality culture
A compliant site is where the employees report small deviations before they get big. Foster a culture of open communication, anonymous reporting, and regular quality walks. Supervisors can talk about GMO behaviors on the shop floor.
In addition, invest in ongoing training. Brief but intensive refresher courses based on actual incidents are much more effective than generic annual training. This way, compliance becomes a normal business process.
Summing up
GMP expectations will keep on changing with technology, regulation, and patient needs. You can remain compliant on a daily basis by utilizing smart software coupled with a strong culture of quality.