OTC Manufacturing and FDA Inspections

10.8.09 | 10:36 am

From the CoValence Laboratories OTC Department

One of the main focuses of the manufacturing department is to find the most effective processes to comply with FDA Regulations and current Good Manufacturing Practices. We need to know what we’re doing right and wrong and, based on that information, implement Standard Operating Procedures to increase our compliance levels. This is a constant focus as every 2 – 3 years an FDA inspector arrives unannounced and delivers a Form 482 Notice of Inspection.

It is during these inspections that the culmination of these efforts are highlighted. The first part of an inspection is usually a tour of the building from Receiving through Shipping while describing our cGMP’s throughout the tour. It’s quite grueling to walk the entire floor describing each aspect from Receiving & QC, Ingredient Storage & Retrieval, Manufacturing & QC, Filling & QC and finally Shipping. Once this is completed the FDA inspector has an idea of the areas he will wanted to focus on for his inspection. We will go over a few Batch Cards from our OTC products manufactured in the past year, and over a wide variety of Standard Operating Procedures. Documentation, Documentation, Documentation! It’s interesting that we can start with a batch card and be expected to show anything from a Certificate of Analysis, or other receiving documentation on an ingredient, to testing results for the finished product and training records for the mixer who produced the product.

These inspections not only help teach us how to improve our cGMP’s for our OTC manufacturing, which naturally spill over to the cosmetic manufacturing processes by necessity, they also ensure that an outside auditing source sets a high standard for our manufacturing facility that cannot be compromised.

Tags: Certificate of Analysis, cGMP, FDA, Form 482, OTC, SOP