As in many company cultures, there are expressions that we use at ChemRite CoPac which are unique to our working environment. If you visit ChemRite, you may overhear employees saying to each other, “consult the manual”. What manual are we referring to?

As a cGMP compliant facility which manufactures OTC (over the counter) products, the FDA mandates that ChemRite must have written procedures for everything we do. While all manufacturing facilities must have a written process, ChemRite’s experienced team has created a comprehensive Quality Assured Manual which goes beyond the standard requirements. It stresses a dependable protocol system and control mechanism for obtaining consistent and sustained quality during production. It also provides corporate direction for the decision-making that takes place from the time a new product is considered until the finished good is shipped.

Organizing the enormous amount of information needed to maintain a consistent standard of quality was no small task. ChemRite’s QA Manual is unique in that it is modeled and titled to follow CFR 211, the code of federal regulations for drug manufacturing. What is the advantage of structuring the manual in this way? A key benefit is it is extremely easy to navigate. Not only is this feature important for internal employee use, but it is also valuable for the external audits the manual is regularly subject to. FDA and customer auditors regularly comment on how easy it is to find the procedures they are looking for during the audit process. The intelligent organization within the structure of the QA Manual is reflective of the focused management throughout ChemRite.

The ChemRite Quality Assured Manual is available to all ChemRite employees for training and review. It educates an employee on ChemRite’s quality discipline and how to accomplish their specific job tasks. It also provides a format for growth and change within the “Quality Assured” system. The end result is an informed employee base with the insight necessary to ensure consistent and sustained quality during the production process.

ChemRite’s Quality Assurance Manual Structure

ChemRite’s Quality Assurance Manual is modeled and titled to follow the CFR 211 code of federal regulations for drug manufacturing. It is broken into the following sub-titles:

  • General Provisions (GEN)
  • Organization and Personnel (ORG)
  • Buildings and Facilities (FAC)
  • Equipment Cleaning (ECN)
  • Maintenance (EMT)
  • Control of Components and Drug Product Containers and Closures (COC)
  • Production and Process Controls (PPC)
  • Packaging and Labeling Control (PLC)
  • Holding and Distribution (DIS)
  • Laboratory Controls (LAB)
  • Records and Reports (REC)
This entry was posted on Tuesday, March 22nd, 2011 at 12:05 pm and is filed under ChemRite Processes.