With frequently changing regulatory requirements, maintaining a high standard of logistics compliance can be a difficult task. The seven steps outlined here will help you understand what is expected of you during a Good Distribution Practice (GDP) inspection, how you can maintain these standards, and what you need to be prepared for questions from inspectors.
1. Understand the expected standard of GDP compliance
Standards can vary globally and can be contradictory from country to country. The aim should be to comply with all regulations set by the countries on your logistics route. If this is not possible, ensure that your reasoning is documented and that you are meeting globally established standards.
Be aware of changes to regulations and stay up to date with investigations and enforcements. This will also give you insight into upcoming areas of focus for regulators.
2. Set and follow a Standard Operating Procedure (SOP)
SOPs allow for the continuous improvement of standards of service and also provide evidence of your commitment towards protecting patients. Failure to write SOPs will signal to regulators that your company is not serious about effective compliance.
However, writing SOPs and then failing to follow them will show regulators a willful disregard of standards. Review and update SOPs regularly and maintain a master file of previous versions.
3. Document your entire process
If you do not document it, you have no evidence that you have actually done it.
Clean, clear and organized documentation can ensure that you are inspection-ready. Ensuring that documents are updated and reviewed at regular intervals is also evidence of the development of your GDP compliance policy.
If you are keeping your documentation in order, you should be better equipped to deal with any issues of non-compliance and pinpoint gaps in the process.
4. Review and manage your CAPA log
Preventive and corrective actions both have an important role in the effective running of quality systems. To be inspector ready, ensure that your Corrective and Preventive Action Plan (CAPA) log is reviewed and addressed regularly.
Corrective actions should be dealt with in a timely manner, with the incident fully recorded along with evidence of how the issue was addressed.
Preventive action should be a key focus to ensure that potential problems or non-conformance are understood and that a plan is being developed. An inspector will respond positively to proactive measures to address any future instances of non-compliance.
5. Check your calibration and preventive maintenance program
Preventive maintenance programs are essential to prove equipment is working to the correct standard and is being monitored or repaired when necessary. Calibration must also be completed and monitored to eliminate any discrepancies between the data recording of different pieces of equipment.
All records of maintenance and calibration should be up to date and ready for review.
6. Bring in fresh eyes to review your GDP process
A fresh pair of eyes can point out gaps in your processes or high-risk areas. Requesting review from different levels of stakeholders can also ensure compliance objectives are understandable and clear.
Experts can give specific guidance on areas of concerns or can offer specialized advice, for example, in preparing employees for interactions with inspectors.
7. Complete a snapshot GDP audits
Ensuring that you are carrying out snapshot audits of your GDP will allow you to stay on top of this complex issue.
Select one area to focus on and review your process and documentation. Ask if it is being followed and if it is effective. Alternatively, create a theoretical incident of non-compliance. Using the process you have, are you able to understand, address and manage the incident?
In conclusion
Every company may face instances of unpredicted non-compliance. Having a fully formed process for GDP compliance can ensure that if an incident happens you are able to mitigate and manage the impact. You will also be able to evidence your actions to an inspector and maintain acceptable compliance standards.
Quick links
- The latest regulatory changes for pharma supply chains
- Meet Pharma IQ’s advisory board: Luiz Barberini, External Manufacturing Operations Manager at Bayer
- Digital transformation of MSD’s “plant-to-patient" supply chain
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- This article was originally published on October 18th, 2018 and updated on November 18th, 2022.