5 Easy Steps to Stay cGMP Compliant
Staying cGMP compliant can be a challenge and requires supplement manufacturers to not only document, but also have employees follow their company-wide processes. If changes occur, then processes and SOPs must be updated and employees trained on the revised procedures. The following steps can help to ensure your company stays cGMP compliant:
cGMP regulations require companies to create written standardized procedures to follow. These are standard operating procedures (SOPs) that comprise each process, from cleaning to pest maintenance, production, quality control, etc. Setting up these standardized processes, and closely following them is required to stay cGMP compliant.
The next step to staying cGMP compliant is to train your personnel and ensure that they are following these standardized procedures. This applies for all departments whether it be taking out the trash, mixing raw materials, or verifying suppliers. The staff needs to follow the established procedures and have a training program that can help them adhere to the SOPs. Management needs to monitor the staff to ensure that they're correctly performing what’s documented. A good way to accomplish this is to ensure that SOPs are always in reach by utilizing a digitalized system; and having user controls in place. With user controls/permissions, certain people can have access to only specific features that they'll perform throughout and ensure that they're following standardized procedures accurately.
Documentation is Required
In order to stay cGMP compliant, adequate and complete documentation is required. This includes keeping records of SOPs, MMRs, Production Records, Product Specifications and Cleaning/Maintenance Logs. There needs to be records so an audit trail is in place and key personnel can have access to review these documents. As stated, training staff on using the SOPs is essential. Also, it’s important to keep records as well.
Good manufacturing practices are all about ensuring quality products. In addition to standardizing procedures and keeping records, it's important to have a full quality control process. Companies need to ensure items and equipment are sanitized, raw materials are tested accordingly, and finished products do not get contaminated. Having standardized procedures for quality control and having personnel ensure adherence, especially with ingredients as soon as they arrive in the warehouse, is of the utmost importance for a quality management system. It’s important that products are:
When a quality control system is in place, there is little chance unintentional contaminants were added or anything adverse happened during the production process.
The OmniBlocks System
The final way to stay cGMP compliant is to use a digitalized system, such as the RB Technologies’ OmniBlocks system, designed to ensure compliance and streamline workflows. OmniBlocks allows a company to standardize their entire production processes and provide an easy way to log those procedures. It provides the user controls and privileges to ensure the staff are only performing their specific job functions. Additionally, it automatically generates and stores all documentation. You just focus on production, shipping, and receiving and OmniBlocks handles the rest. Additionally, the quality checks are customized and built in throughout for whatever is needed. Using OmniBlocks is an easy, foolproof way to stay cGMP compliant while making these regulatory burdens an afterthought.
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