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Standard Operating Procedures

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Implementing a quality system for Good Manufacturing Practices is required by the FDA. Their regulations are written in very general terms, so they have to be interpreted for each type of manufacturing operation. These interpretations show up in the policies and standard operating procedures (SOPs) that are written by the manufacturing experts of InstantGMP. These SOPs provide the foundation for a total quality system.

The following SOP sets are available for sale separately, or may be included with InstantGMP software packages:

Full PRO SOP Set

110 SOPs and policies designed for any FDA regulated manufacturing operations like biopharma, non-California cannabis, CBD, dietary supplements, herbal products, kratom, and pharmaceuticals.

INV Management Set

11 SOPs and policies compliant with Good Manufacturing Practices (GMPs) for inventory management. These documents primarily focus on guiding companies in creating and implementing tests, methods, and Specifications crucial to compliance requirements. Additionally, these documents help in assisting companies better organize their inventory.

CA Cannabis Set

109 SOPs and policies compliant with the CA recreational cannabis regulations.

Holding/Distribution Set

A set of 68 SOPs, Policies and templates that provides a quality system for any Holding and Distribution company.

The FDA requires compliance with GMPS in manufacturing, packaging, labeling, and holding operations for dietary supplements. That means the FDA expects that the distributor of the final product that reaches the consumer will also have responsibility for assuring the products they receive comply with all the GMP requirements. The Holding and Distribution company has to ensure that packaging and labeling were done as specified in the master manufacturing record and ensure the quality of the product that reaches the market. Failure to comply means the FDA will consider these products to be adulterated.


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