Three keys to building quality into your packaging operation
Recently, the Food and Drug Administration issued a draft guidance* on quality systems. Within this guidance document is the following statement: "Quality should be built into the product, and testing alone cannot be relied on to ensure product quality."
The three keys to building quality into your packaging operation are as follows:
1. Technical experts. Technical experts must design, qualify, and maintain the packaging operation. They must have a thorough understanding of the product, the package, and the regulatory requirements.
2. Documentation. Maintain documentation generated by the technical experts in an organized filing system. These files must be easily accessible for the completion of compliance functions such as Corrective and Preventive Action (CAPA) and Change Control. In addition, the documentation utilized during packaging should include steps to minimize the risk of contamination and mix-ups within your packaging operation.
3. Training. All persons involved with packaging operations must understand the equipment and the product. This can be accomplished with in-house and outside training classes, using the documentation mentioned above. With this knowledge, quality improvements can be realized and implemented on a continuous basis.
These three keys cover broad areas of quality systems within your packaging operation. These areas should be tailored for each packaging operation.
* FDA's Guidance to the Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations, September 2004
--By Linda McBride, Registered Pharmacist
Linda McBride is director, regulatory affairs, for Medi-Flex, Inc. Her 16 years of pharmaceutical industry experience include work for Bayer HealthCare, Oread, and Novartis. She has a B.S. in pharmacy and is a registered pharmacist, and is a member of the International Society for Pharmaceutical Engineering.
