While the novel feminine hygiene product is being assessed for safety and effectiveness, the production process is being developed. A good quality production process must ensure that the product and its manufacturing meet several requirements. This applies to clinical studies, normal consumer studies, and market shipment alike.
1. First and foremost, consumers expect a good and functional product that delivers the desired performance. Production should follow good manufacturing practices. This means that high hygiene standards (in building, equipment, and operation) and high manufacturing quality must be provided.
2. On feminine hygiene products, there are numerous regulations worldwide that must be met. Governmental agencies, such as the U.S. Food and Drug Administration (FDA), reserve the right to audit manufacturers for compliance. A good quality system reflects all necessary requirements in written procedures and ensures that regulations are met. These are properly included and documented in the relevant work processes.
3. A growing number of trade customers require a quality certification from the manufacturer. The ISO 9001:2000 certificate is the most common global system. This is the trade's safeguard that manufacturers follow a quality system that has been certified by a third party.
4. In many countries, liability laws have changed, and manufacturers have to provide evidence of their standards in court. Operations must be transparent and the work traceable. Production is allowed only according to approved standards, procedures, and good documentation. Production equipment and processes must be validated for their purpose and only quality materials can be used. The product is released into the marketplace only when it meets all specifications.
5. A consumer-response system is needed to provide the consumer with the means to ask questions or to provide testimonials or comments/ complaints. Such a system not only helps to satisfy consumers, but is also a great analysis tool to learn of market successes and failures and to improve internal systems in the manufacture of a product that will provide consumers with the desired experience.
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