Validation related to a machine or equipment, rather than process validation, then the approach is referred as Qualification. It is part of, but not limited to, A validation process, which in turn can be divided into below:
Installation Qualification (IQ) – It provides documented evidence of high degree of an assurance that the system / equipment has been installed according to an appropriate & approved technical design specification.
Operation Qualification (OQ) – It provides documented evidence of high degree of assurance, that the system / equipment performed the operation as required by the system specification. Performance Qualification (PQ) – Validation is a process of establishing documented evidence that a system / equipment / process, performs the functions that it has been designed to perform. The Validation is said to be through when such system / equipment / process can be performed under standard normal circumstances without giving any deviation in the performance that it is designed for. It is an important part in identifying if any deviation is identified in the final output.
Execution of Validation and Qualification Process of Sansec Pharma follow the systematic scheme and will be completed.
There is a risk when upgrading to a new system for adapting the new work flow (Software/Hardware). The degree of sophistication of the risk assessment will depend upon available resources. As risk assessment is vital for identifying possible risk mitigation strategies and incorporates the system boundary entity into the Validation Plan and Project.
Typically, control system integrators or system suppliers are not trained in current good manufacturing practices (cGMP) or good X practices (GxP) relating to Food and Drug Administration (FDA) compliance where ‘x’ can mean clinical, laboratory, manufacturing, pharmaceutical and others. They also do not possess the solid validation operational experience and planning required for FDA compliance. The gap between supplier and users in the pharmaceutical industry is obvious, and problems caused by this gap can be numerous. As a result, good automation manufacturing practice (GAMP) has come into being to address these issues as it considers the overall automation system validation methodology. Even GAMP serves to provide a guideline only rather than dealing with practical development of the validation cycle.
The FDA and other regulatory bodies require spreadsheets to be validated and compliant with 21 CFR 11. During compliance audits, the FDA has recently focused more attention on the use of spreadsheets. We Sansec Pharma Solutions, with our experts in spreadsheet validation, can ensure that your spreadsheets are compliant with all regulatory requirements. We also offer Scientific calculator calibration services.
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