Cleaning validating individual pieces of equipment
Such procedures are developed through the process of validation.
This is to maintain and assure a higher degree of quality of food and drug products.
The first validation activities were focused on the processes involved in making these products, but quickly spread to associated processes including environmental control, media fill, equipment sanitization and purified water production.
The concept of validation was first developed for equipment and processes and derived from the engineering practices used in delivery of large pieces of equipment that would be manufactured, tested, delivered and accepted according to a contract Here, the software for a large radiotherapy device was poorly designed and tested.
6) which states that: This requirement has naturally expanded to encompass computer systems used both in the development and production of, and as a part of pharmaceutical products, medical devices, food, blood establishments, tissue establishments, and clinical trials.
In use, several interconnected problems led to several devices giving doses of radiation several thousands of times higher than intended, which resulted in the death of three patients and several more being permanently injured.
In 2005 an individual wrote a standard by which the transportation process could be validated for cold chain products.
Qualification includes the following steps: There are instances when it is more expedient and efficient to transfer some tests or inspections from the IQ to the OQ, or from the OQ to the PQ.
This is allowed for in the regulations, provided that a clear and approved justification is documented in the Validation Plan (VP).
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The desired results are established in terms of specifications for outcome of the process.