CGMP Best Practices & Compliance

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimise the risks involved in any food, cosmetic or pharmaceutical production that cannot be eliminated through testing the final product. cGMP is used to refer to the 'Current Good Manufacturing Practices'. The “c” in GMP just means current. The regulations require that manufacturers follow Good Manufacturing Practices. The “current” in front of that just acknowledges that what is considered 'good changes' over time. To simplify this, GMP helps to ensure the consistent quality and safety of products by focusing attention on five key elements, which are often referred to as the 5 P's of GMP—people, premises, processes, products and procedures (or paperwork). And if all five are done well, there is a sixth P … profit!

The FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations.  The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.  The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have. These guidelines which are updated by the FDA can be found here. Through certain features of Centralpoint (e.g. authentication, electronic signatures, audit trails), we aim to help our customers set up, manage, and record your processes to achieve compliance with various international regulations, policies, and other applicable standards related to their needs such as ISO 17025, GxP, etc.

Compliance with any applicable standard depends not only on the tool used but on the way it is being used by the customer and on their processes, over which we have no control over. This is especially true since Centrapoint would be installed either On premise or within the private, compliant cloud fo our client. For example, a laboratory can use off-the-shelf Microsoft Excel as a part of an ISO 17025 compliant process or service, providing that certain measures and procedures required by the standard related to calibration of equipment and validation or methods, etc. are implemented. Any compliance is a multi-faceted issue and no software or service provided by Centralpoint (or any other service provider) can guarantee compliance. Even though we follow the industry standards to design and implement those features compatible to general good practices, it is up to you to take appropriate actions, since the features alone do not and cannot substitute such actions. We also do not have the authority to provide legal interpretations of such documents/procedures and therefore we are not in the position to ever assure it. If you are thinking of using Centralpoint for electronic records management for CGMP environment, you may also find yourself thinking about how you are going to be validating the system. Centralpoint validation is fairly straight-forward, but it will require some preparation on your part. Here is a list of steps to take to prepare for a successful validation project. Read more about FDA validation requirements and Centralpoint.

Step 1 – Decide if your Centralpoint Instance Actually Needs to be Validated

Understand the intended use of system. Ask yourself if the system will be used to manage regulated electronic records. If your inspectable records are still paper-based, then you may not need to validate Centralpoint at all. If your inspectable records are logically segregated from non-regulated documents (based on your Centralpoint architecture), then you may only need to validate isolated sections of the system.

Step 2 – Prepare a Project Plan

Get organized. List out the required activities and figure out how much time you need. Validating Centralpoint could take longer than you think, but with the right resources and proper planning, you could close out the project in little time. Get commitment from the project sponsor, and then from your assigned resources.

Step 3 – Get your Infrastructure Ready

You can’t build a house without a solid foundation. The same is true for Centralpoint. Design your infrastructure so that it supports the Centralpoint architecture that suits your business needs. Consider storage and performance requirements. Consider a cloud-based service model.

Step 4 – Get your Procedures Ready

You need proper procedures (e.g. change control, security, data backup and recovery, etc.) to ensure your system is maintained under a state of control. Your system cannot be considered validated without the proper procedures in place.

Step 5 – Train (and retrain) Your People

Train your system administrator(s) – They need to maintain the system’s state of control and must be aware of user access management procedures and change management policies.
Train your validation team – Make sure that people involved in system verification activities are aware of validation policies and good documentation practices.
Continued re-training is essential to guarantee new hires are familiar with the protocols, and/or existing staff is up to date with the latests updates from the FDA.

Step 6 – Prepare the Required Documentation

Requirements, Specifications, Test Protocols – all are needed. Consider leveraging the knowledge of consultants who have worked with Centralpoint before. One working session with subject matter experts can boost the learning curve of your in-house resources dramatically. And this will accelerate document preparation and improve document quality.

As with any validation project, proper planning is crucial for the successful validation of your Centralpoint instance. Understanding what you are faced with before you start the project will help you restrict scope and avoid technical hiccups. Being prepared with the right resources and tools will save you lots of time (and money) in the long run.