Along with the documentation needed for use, operation and maintenance that comes with every Schmucker machine, the client can request a Protocol Validation in accordance with the standards GMP and GAMP 4. This documentation provides the highest guarantee that a specific process generates a product with the pre-defined specifications and its quality attributes.
The IQ OQ validation documents and controls, by means of the Protocol of Validation, the functions, features, and operation of the specific machine.
The Protocol of Validation is prepared based on the provisions of the standards GMP (Good Manufacturing Practice) and GAMP 4 (Good Automated Manufacturing Practice) created for and used by the pharmaceutical sector.
A team of skilled technicians deals with all the forms for the testing the system is to undergo and the preparation of documents such as FS, DS, IQ/OQ Test Protocol.
21 CFR PART 11 OF THE FDA (documentation security)
Schmucker, which also works in the pharmaceutical and food sectors, has always given the utmost attention to issues such as quality, tracking of data and care for instrumentation that is used. This commitment is driven by the innate skill and professionalism that characterize the company, and recently by the need to meet the validation requirements of the FOOD AND DRUG ADMINISTRATION (FDA).
The FDA validates each production process and required documentation evidence that any food or drug product has followed a proper production process, in accordance with the various phases established by international standards and established norms.
The document 21 CFR part 11 specifically analyzes documentation security and requires companies that produce drugs for human use to follow certain guidelines concerning identification, tracking and authentication of documents concerning the development and production of those drugs.
The FDA requires constant filing of documents during the production phase. These documents may be inspected at any time.
The document 21 CFR part 11 therefore establishes the guidelines to be followed so that any system is able to provide the documentation and electronic signatures to ensure the possibility to verify and validate those documents, for the recognition of the operator and the printing of production documents.