U.S. FDA approved quality system. Code of Federal Regulations (CFR) Title 21.
EU GMP quality system, EudraLex Volume 4 on medicinal products.
WHO Technical Report Series (TRS) GMP quality system considerations.
You want or need to obtain a GMP quality management system, but where do you start? In this step-by-step plan, we explain how an organization prepares for GMP certification.
Preparing for a GMP quality management system
First of all, you will make an inventory of what is already present within the organization that meets the aspects of the GMP standards. Map the processes of your organization, paying special attention to your primary process: the medicine you produce or develop. Once this has been mapped out, you can easily make a plan for the implementation of a GMP quality management system. You can get started with the implementation yourself, follow GMP training courses or call in an expert. PCS can be retained in a coaching role or take over the entire GMP implementation process. This depends on the wants and needs of your organization.
Writing the GMP SOP's and other documents
Gather as much information as possible within your organization by entering into dialogue with various disciplines; manufacturing/QA/QC/R&D/etc. This information helps you shape your quality management system. Talk to the management, get management support, and formulate the objectives that will be worked on by the entire company in the coming year. It's not QA who's responsible for implementing a QMS. In addition, you assess the critical suppliers, perform risk assessments and ensure that your colleagues are trained on the GMP procedures.
Ensuring involvement & management review
Ensuring management involvement is a critical GMP element. Have regular updates with the management team on the quality system implementation. This will help management to address any issues in a timely manner. Such meetings are an opportunity to discuss management review contents, composition and frequency.
Comparing theory to practice
An internal audit is an opportunity to iron out any wrinkles. Do your SOP's really work? Are they embraced by their users? This input allows you to readjust documents/your strategy. In an internal audit it is important that objectivity is guaranteed. You can do this by having the internal audit performed by a PCS consultant or by training someone internally.
Getting a stamp of approval
The cherry on the top. The moment all your hard work gets a stamp of approval. Some organizations will receive a regulatory inspection by their national regulatory authority. If you are exporting medicinal products to the EU it is most likely you will be inspected by a Qualified Person (QP). If you are inspected by the government and pass the test you will be issued a GMP certificate. When you pass the QP inspection you may export to the QP's organization in the EU.
You can't always eliminate risks in a final product. A car's brakes can be tested before delivery, but we cannot test every vaccine on impurities before injecting it. The good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to a predetermined set of quality standards. It is designed to minimize the risks involved in pharmaceutical production.
An essential element of the GMP is the quality management system, or QMS, it allows manufacturers and regulators to ensure medicine are produced in a consistent manner. When things do go wrong it allows manufacturers to trace where, when, why and how something failed, allowing the manufacturer to formulate corrective and preventative actions.
Besides the obvious advantages you will have greater control over your quality, your process and thus limit the amount of rework. The GMP certificate opens up export opportunities, reduces costs and increases the trust your customers have in you.
Perhaps the most important benefit of the GMP's is that they do not place the patient at risk due to inadequate safety, quality or efficacy.
Turning raw materials into finished products is a complex process. Start mapping the steps and everything involved. Involve experts and find potential bottlenecks.
Where can you save time? Convert messy, recurring tasks to textbook examples of efficiency and effectiveness. Fixing this now sets you up for succes in the future.
Make everyone responsible for quality. Assign ownership over activities and processes. Promote reporting defects. Your biggest asset will be your quality culture.
Avoid creating a bureaucratic masterpiece. Excell at creating a simple, yet effective GMP quality system. Make versioning and SOP distribution easy and efficient.
Incremental backups on-site and off-site are a minimum requirement. You don't want to spend weeks getting your data back. Test restore and recovery of backups often.
Checking 300+ procedures at once is not what your quality assurance manager signed up for. Keep everyone's blood pressure low by implementing your procedures in phases.
We are happy to visit your organization for an introductory meeting. During this meeting, one of our GMP experts will visit you on location or digitally. We'll go over your company, your wishes and our working method. After this conversation we will make a tailor-made offer.
During the introductory meeting, we take a look at your current process and what may be needed for GMP certification. Haven't mapped your process yet? No problem, we will do it together. Do you have an existing management system or have you already started setting it up? Then we do a baseline measurement to help you with the implementation process.