By Anthony P. Banaszewski
Technical Director, Sonneborn, LLC
If you are already using Sonneborn products you are likely familiar with the terminology cGMP (current Good Manufacturing Practices) and what it means. The premise of cGMP is that the quality system is based on the principles of Quality by Design instead of Quality by Inspection. Sonneborn has been committed to the practice of Quality by Design long before GMP was established by the FDA, and continues to sustain the caliber of Sonneborns QA procedures to this day.
The Sonneborn Quality Heritage
The Sonneborn tradition for quality has its origin in the troubled times during World War I. The supply of European white mineral oil (aka Russian oil) to the United States was cut off by wartime restrictions. It was then that L. Sonneborn Sons, Inc. began the production of white mineral oil to meet the needs of the American pharmaceutical industry. The evolution of technical expertise from this development was recorded for operational guidance and future reference. These records came to be known as 'manual sheets' or Petrolia Manufacturing Guidelines, i.e., PMGs.
These PMGs were entered in a series of loose-leaf notebooks whose titles spanned all phases of plant production from accounting procedures and analytical methods to material specifications and steam production. These manual books of PMGs became the foundation of the Sonneborn manufacturing philosophy whose objective was to produce quality products with lot to lot consistency that satisfied the customer requirements.
In the late 1970s, the Food and Drug Administration (FDA) prescribed the Good Manufacturing Practices (GMP) regulations for manufacturers of drug products such as white mineral oil and petrolatum. Sonneborn's PMG's were so comprehensive in scope that they anticipated and satisfied most of the new GMP regulations. Today, the GMP's are the backbone of Sonneborn's quality assurance procedures. The stringent testing, inspections, and documentation procedures required for FDA products are employed in the manufacture of both FDA and non-FDA products.
John J. Kaufman, R&D Manager, Petrolia, PA, April 1986
Do you use Sonneborn products in drugs, medical devices, cosmetics, food ingredients, food contact applications, as excipients or APIs (active pharmaceutical ingredients)? If you do, you can be assured that the material is not "just tested" to verify compliance to a monograph. Sonneborn's manufacturing and delivery process is specifically designed for the industries we supply. Our quality system includes the tenets of each cGMP applicable to the use of those products.
cGMP guidelines for specific applications can be found in various documents. Whether it is 21CFR211 for finished pharmaceuticals, ICH Q7 for APIs, International Pharmaceutical Excipients Council (IPEC) Guide for excipients, 21CFR110 for food application or the FDA's Inspection Operations Manual for cosmetics, there are common expectations for materials manufactured in compliance with cGMP.
So, what are some of the aspects of Quality by Design?
Quality Management: There should be a "documented system" for managing quality that includes educated, trained, and experienced personnel. This applies to both the manufacturing and quality units. Quality units are independent of production and are responsible for quality control (QC) and quality assurance (QA).
Buildings and Facilities: Location, design, and construction should be able to facilitate cleaning, maintenance, and operations.
Process Equipment: Equipment used in the manufacturing, processing or packaging should be of appropriate design for its intended purpose. Materials of construction should not be reactive, additive, or absorptive so as to alter the safety, purity, or quality of the product.
Control, monitoring and test equipment should be calibrated and traceable to certified NIST standards, if available.
Documentation and Records: Control records should be maintained that include all aspects of raw materials, production, specifications, sampling, and testing.
Materials Management: There should be written procedures describing the receipt, identification, quarantine, storage, handling, sampling, testing, and approval or rejection of materials.
Production and In-Process Controls: Manufacturing controls should be established and written instructions, formulations, processing, transfer, filling instructions, and in-process control methods should be maintained.
Packaging, Identification and Labeling: Written procedures should describe the receipt, identification, quarantine, sampling, testing, release, and handling of all packaging and labeling materials.
Laboratory Controls: Independent quality units should have written procedures describing sampling, testing, approval or rejection of materials, and recording the retention requirements for laboratory data. Appropriate specifications should be established for materials that can determine contamination and Out of Specification (OOS) events.
Validation: Validation should extend to those operations determined to be critical to the quality and purity of the products. Many approaches to process validation may be applicable, depending on the critical nature of the products, the critical characteristics, and the stage/history of the processes involved.
In addition to the subjects mentioned, cGMP systems will have documentation and procedures addressing subjects like Change Control, Reject and Re-use of Materials, Material Returns, Reserve Samples, Stability Monitoring, and Complaints/Recalls.
There are many details associated with a cGMP system that have not been addressed here. Sonneborn's Petrolia, PA manufacturing facility has been audited many times by our Pharmaceutical customers and on a regular basis by the FDA with very good results. Using a continuous improvement philosophy, we are always seeking to upgrade our capability and meet our customer's expectations for quality, service, and delivery.