Lets Talk cGMP
cGMP is the first line of defense in keeping your product safe. Regardless of the product type, ALL food manufacturers and service professionals are required to follow cGMP according to the Code of Food Regulations (CFR).
FDA and USDA Auditors will be looking for implementation of these practices. Failure to follow these practices puts your product and business at risk.
cGMP cover details and areas of the facility in the following categories as stated on the FDA website:
- General Personnel
- Plant and Ground
- Sanitary operations
- Sanitary Facilities and Controls
- Equipment and Utensils
- Processes and Controls
- Warehousing and Distribution
- Holding and Distribution of human food by-products for use as animal food
- Default Action levels
Here are some specific examples of how ASI can help you with cGMP regulations:
- ASI can help you develop a quality management system that meets the requirements of cGMP regulations.
- ASI can help you develop SOPs for all aspects of your manufacturing process.
- ASI can help you train your staff on cGMP regulations and best practices.
- ASI can help you audit your manufacturing processes to identify any potential compliance issues.
- ASI can help you develop a plan to address any potential compliance issues.
By working with ASI, you can be confident that your manufacturing processes are compliant with cGMP regulations. This will help you protect your business and ensure the safety of your products.
If you are interested in learning more about how ASI can help you with cGMP regulations, please contact us. We would be happy to discuss your specific needs and how ASI can help you achieve your goals.
cGMP Audit Overview:
A cGMP audit is an assessment of a facility's compliance with current Good Manufacturing Practice (cGMP) regulations.
During a cGMP audit, a qualified auditor will review the facility's operations, processes, and documentation to ensure that they meet cGMP requirements. The auditor will evaluate various aspects of the facility, including:
- Equipment and facility maintenance: The auditor will evaluate the facility's equipment and infrastructure to ensure that they are properly maintained and cleaned.
- Documentation: The auditor will review documentation related to production, quality control, and testing to ensure that it is complete, accurate, and properly maintained.
- Standard operating procedures: The auditor will review the facility's standard operating procedures (SOPs) to ensure that they are up-to-date and accurately reflect the facility's processes.
- Personnel: The auditor will review the facility's personnel training records and qualifications to ensure that they are adequate for the tasks being performed.
- Quality control: The auditor will review the facility's quality control procedures to ensure that they are adequate for maintaining product quality and safety.
What are the ADVANTAGES of cGMP Certification?
Besides meeting regulatory and customer requirements, there are numerous other benefits to receiving a cGMP audit. Some of these benefits include the following:
- Improved quality control: cGMP certification requires strict adherence to quality control processes, which can help improve product quality and reduce the risk of defects and product recalls.
- Increased customer trust: cGMP certification is recognized globally and can help build customer trust by demonstrating that a company is committed to producing high-quality products that meet regulatory requirements.
- Better product consistency: cGMP certification requires standardized processes for product manufacturing and testing, which can help ensure consistent product quality and reduce variability in product performance.
- Competitive advantage: cGMP certification can help companies stand out from competitors and win contracts with customers who require or prefer cGMP-certified suppliers.
ASI cGMP Audit List
ASI is a leading provider of cGMP auditing services. The company has a team of experienced auditors who are familiar with the latest cGMP regulations. ASI's audits can help companies identify and correct cGMP violations, which can help to prevent product recalls and other regulatory issues.
In addition to helping companies comply with regulations, ASI's audits can also help to improve the quality of products. By identifying and correcting any potential problems, ASI can help companies to produce safe and effective products that meet the needs of their customers.
cGMP - Food Processing
Geared towards food and based on 21 CFR 117
cGMP - Dietary Supplements
Geared towards dietary supplements and based on 21 CFR 111
cGMP - Food Packaging
Geared towards food packaging and based on 21 CFR 117
USDA Harmonized GAP+
Good Agricultural Practices (GAP) audits are voluntary audits that verify that fruits and vegetables are produced, packed, handled, and stored to minimize risks of microbial food safety hazards.
cGDP - Storage and Distribution
Geared towards storage and distribution centers and based on 21 CFR 117
cGMP - Cannabis