Take a walk around any Walgreens or CVS store and you’ll find hundreds, if not thousands, of cosmetics, medications, medicines, and pharmaceuticals available over the counter or from the pharmacy. If you watch television, listen to radio or browse the Internet, you are bombarded with advertisements for the latest cold remedy, hand lotion or shampoo to make you feel better, look better or cure some illness. These personal products and medications are intended to alter your look, mood or well-being, and therefore have the potential for good or harm.
In the pharmaceutical industries, quality refers to the identity, strength and purity of a product which relates to its safety and effectiveness. The public relies on the integrity and accuracy of pharmaceutical and cosmetics’ labeling and instructions to protect them from harm. Current Good Manufacturing Practices (CGMP) established quality standards within these industries to ensure products are safe and deliver the intended benefit or result. CAPAs, or Corrective and Preventive Actions, are processes used to investigate, identify and correct non-conformance as part of the CGMPs.
The Food and Drug Administration regulates the manufacture, production and approval of these types of products. While it imposes strict guidelines, how a company regulates itself to adhere to the standards and its own internal processes leaves room for variation and error.
Industrial manufacturing and service industries can achieve ISO 9001:2008 quality system certification or some industry specific variation of the ISO 9001 standards in order to conform to globally accepted quality standards. In the United States, the FDA has established current Good Manufacturing Practices, or CGMPs, which outline quality system standards for food and drug manufacturers. CGMPs are not new or additional regulations for these industries. Rather, they establish standards for a quality system for these manufacturers similar to ISO 9001:2008.
The CGMPs are similar to ISO quality standards.
There are four major sections:
- Management Responsibilities — As with ISO 9001:2008, management has overall responsibility for the establishment and support of the quality management system. They provide the resources, leadership and support within the organization for the establishment and maintenance of the system. They also are responsible for management review.
- Resources – Management is responsible for providing the proper facilities and equipment to process and manufacture products according to specification and quality standards. The quality system also establishes guidelines to acquire and receive materials and for processing materials for use. It also provides for proper laboratory facilities and equipment to properly test and approve product samples and a system to document and affirm results. Qualified, trained personnel to perform all operations are another vital resource.
- Manufacturing Operations – Quality systems rely on the proper design, development and documentation of manufacturing operations systems, procedures and work instructions. Once established, there must be a process for controlling documentation, updating for quality improvement and ensuring documents and electronic systems are secure and controlled.
- Evaluation Activities – Corrective and Preventative Action (CAPA) is a well-established quality process that seeks to identify the root cause of deviations in quality process and product non-conformance to eliminate the cause and prevent further occurrence of the same or a similar situation. CAPA uses a closed-loop process to identify the source of a non-conformance and establish a plan of action for closure. Root cause analysis can involve customer complaints, end-users, vendors, workflow management, the training and experience of operators, reliability of documentation, quality of internal audits and the corrective and preventive action system itself.
Whether the CAPA system is electronic or manual, a reliable CAPA system is a vital component to CGMPs and ensuring the quality and integrity of manufacturing processes and products under FDA regulations.