Maintaining GMP and FDA compliance is crucial to the operations of any pharmaceutical, dietary supplement or biotech manufacturer. To ensure that manufacturers are in compliance with all current regulations and standards, the FDA performs audits and inspections of manufacturing facilities.
During these audits or inspections, FDA inspectors look for any possible violations of compliance. If those violations are significant, the inspectors issue warning letters that provide the details of the specific regulatory violations and outline the corrective action the facility needs to take. If the manufacturer does not take prompt action to restore compliance, the FDA may take additional enforcement action, including seizure of products and injunctions.
Receiving a warning letter is a serious matter for any manufacturing company. Yet, many manufacturers violate compliance for one of the most surprising reasons: lack of adequate documentation.
In the following article, we will discuss the reasons why good documentation is necessary for GMP and FDA compliance, highlight some of the ways manufacturers can avoid documentation-related violations, and demonstrate how InstantGMP™ PRO helps improve documentation of GMP procedures.
Why Good Documentation Is Important For GMP & FDA Compliance
Since there are so many GMP requirements for making and distributing good quality pharmaceuticals and dietary supplement products, operators need to follow written procedures to assure that each of the requirements are met during the manufacturing process.
At the same time, it would be impossible for FDA inspectors to know if manufacturers are following these procedures without proper documentation.
By creating written procedures, such as Batch Production Records (BPR), production and quality staff can be easily trained on how to correctly and consistently produce a quality product and document each step of the production process. When staff follow these written procedures every time they create a new batch of a product, they avoid violations and ensure GMP compliance.
Without written procedures, the staff may not remember the correct way to do things. This could result in the performing steps out of their proper sequence, skipping steps, adding the wrong amount of ingredients, or using the wrong equipment. All of these instances result in low quality products and compliance violations. Written procedures enforce uniformity and quality which is what consumers deserve and the FDA mandates.
Proper documentation is also essential for accurate inventory management and materials traceability. During the production process, operators not only have to use the correct ingredients and measurements as outlined in the BPR, they also have to document the exact amount of that specific ingredient that should be subtracted from the inventory.
When production staff fail to document the specific ingredients used in a batch or the exact amounts of each ingredient used, it results in a lack of materials traceability and inaccurate inventory levels. Both of these instances place the facility in violation of compliance with GMP standards and FDA regulations.
The examples above are just a sliver of the reasons that good documentation is important to maintaining compliance. In addition to taking corrective action to avoid the scenarios above, there are also many additional steps you can take to avoid violations due to a lack of documentation.
How To Avoid Documentation-Related Violations
Since the lack of documentation is a common failure among manufacturing companies, FDA inspectors pay particular attention to the regulations that require documentation.
To adhere to these regulations and ensure compliance, manufacturers should always follow the rule “Document what you do, and do what you document.”
To put this rule in practice, manufacturers should take the following steps:
- Create Standard Operating Procedures (SOP) based on the FDA’s guidance for maintaining GMP compliance and follow them during every phase of the manufacturing process.
- Establish written procedures for manufacturing operations.
- Create and maintain records of the written procedures for cleaning the facility and all equipment.
- Confirm that quality control personnel approve or reject all processes, written procedures, controls, tests and examinations, and deviations.
- Provide a control process for the issuing and using the product labels.
- Set up procedures for sampling and provide a cross-reference to procedures for tests or examinations.
- Institute and document corrective action plans for use when a specification is not met.
- Provide documented proof that quality control personnel reviewed the results of tests or examination of any in-processing or finished product at the time of performance
- Preserve written records as required for one year past the shelf life date, if the shelf-life dating is used, or two years beyond the date of distribution of the last batch of the respective product associated with the records
Improving Documentation Of GMP Procedures with InstantGMP PRO
Creating, maintaining and preserving documentation of GMP procedures is necessary for compliance with FDA regulations. Unfortunately, the level of documentation required for compliance is incredibly difficult when using a paper-based system.
Following traditional physical documentation of GMP procedures is prone to inaccuracies, inefficiencies and neglect. In addition to these deficiencies, paper-based documentation systems suffer from storage and misplacement issues.
Rather than run the risk of violations associated with paper-based systems, companies can improve their GMP procedures documentation and ensure compliance with InstantGMP™ PRO software:.
With our cloud-based all-in-one manufacturing and quality system, manufacturers benefit from the following integrated modules: :
- Electronic Batch Records (EBR): Simplifies the process for the development, production and identification of Master Production Records (MPR) and Batch Production Records (BPR), provides greater quality control, improves workflow management, and increases safety.
- Quality Management System (QMS): Allows staff to perform quality assurance activities, control all documentation involved with data collection for deviation tracking, root cause identification, and investigations, and manage the required specifications for verifying the identity of incoming raw materials and outgoing finished goods.
- Inventory Management: Permits specialists to trace, monitor and record every part of the inventory process from the ordering of materials to the production of quality products.
- Learning Management System (LMS): Assigns relevant coursework to new hires and existing staff and uploads certifications to employee files.
- Document Management System (DMS): Allows manufacturing facilities to easily store, organize and secure access to every file, record and video associated with production processes, and permits staff to quickly locate documents for review, updates and approvals across every phase of the production processes..
In essence, InstantGMP PRO replaces the traditional paper-based system with an cloud-based all-in-one manufacturing and quality system that enhances GMP documentation procedures to avoid violations and maintain compliance.
Due to a lack of documentation, many manufacturers run the risks of violationing compliance, receiving FDA warning letters, and being subjected to seizures and injunctions.
All of these risks can be avoided by improving GMP documentation procedures with our all-in-one manufacturing and quality system.
To see a demonstration of InstantGMP PRO and all of its fully integrated modules, please contact our team today!