Good Manufacturing Practice and Us

Good Manufacturing Practice (GMP) guidelines exist to protect the end user of a product from harm. These guidelines provide direction for manufacturing, testing, and quality assurance to ensure that a final product is safe for human use or consumption. In the United States, the Food and Drug Administration (FDA) requires companies to follow GMP when manufacturing certain products. In our case, it affects our manufacturing of antibacterial hand soap and hand sanitizer.

Principles of Good Manufacturing Practice

• Maintain a clean and hygienic manufacturing area
• Maintain controlled environmental conditions to prevent cross-contamination
• Manufacturing processes must be clearly defined and controlled; all critical processes must be validated to ensure consistency and compliance
• Any changes to manufacturing processes must be properly evaluated; any changes that affect the quality of the product must be validated
• All instructions and procedures must be written in clear, unambiguous language using good documentation practices
• Operators must receive proper training to carry out all applicable procedures
• During manufacturing, records need to be kept that demonstrate that all required steps in the procedure were taken and that the final product was as expected (both quantity and quality)
• All records of manufacture must be retained and accessible to enable tracing of batches
• Distribution of products must minimize risk to product quality
• A system must be in place for recalling a batch
• Complaints about marketed products must be examined and the cause of defects must be investigated; appropriate measures must be taken to prevent recurrence

To ensure that manufacturing facilities are following GMP, regulatory agencies are authorized to conduct unannounced inspections of the facilities. This means the FDA can come in for a visit to confirm that we are following the necessary guidelines in GMP. Ultimately, this protects the end user from unsafe products.

For us at Celeste, following these guidelines means doing our due diligence to ensure that our products are consistent and safe for people to use. It takes a lot of time and additional effort, but it is worth it to maintain our high standards of quality and to ensure the safety of our customers.