When it comes to controlling the production and process of products, there are several aspects to consider. Here are some details on each:

• Record-keeping: Each action taken for traceable activities such as manufacturing and control of products should be recorded. Good documentation and record keeping are essential parts of the quality assurance system and are required in compliance with Good Manufacturing Practice (GMP) requirements. Accurate record-keeping can help managers and supervisors keep track of the historical record of manufacturing procedures and corrective measures implemented.

• Quality control: GMP is concerned with production and quality control, aiming to mitigate the risks that are inherent in the production process. All materials used for production should be stored properly according to the appropriate conditions set by the manufacturers, and there should be a proper stock management system implemented to ensure that all incoming materials are correct and of high quality.

• Ingredients or materials: There are regulations in place for testing and approval or rejection of components, drug product containers, and closures. Materials examination and usage criteria are also established. For nonsterile drug products, control procedures should be established to monitor output and validate processes to include bioburden testing and establish and follow written procedures designed to prevent the introduction of objectionable microorganisms.

• Positive and negative details: Temporary status labels serve a valuable purpose of positively identifying the current status of equipment and the material under process. However, there is no value in retaining such labels in addition to the required equipment log or batch record documentation.

In summary, controlling the production and process of products involves record-keeping, quality control, regulations for ingredients or materials, and positive and negative details.