pls about the Equipment qualification breifly
There is 3 types of validation - IQ, OQ and PQ
• Equipment installation qualification - In the instrument/installation qualification (IQ) process, equipment to be used in packaging processes is evaluated to help ensure that it operates as intended. Specific parameters typically include the installation setting and the environmental conditions to which the equipment is expected to be subjected, to help ensure that they conform with the specifications of the equipment manufacturer. Software validation may also be required in cases 5 Validating Medical Device Packaging where the operation of installed equipment is controlled or managed by software. Finally, the IQ evaluation should include an assessment of operator training, as well as for instructions for routine equipment cleaning and maintenance.
• Operational qualification - In the second qualification step, operational qualification (OQ), the instrumental parameters for the forming, sealing and/or assembly of packaging systems are evaluated. The goal of OQ evaluation is to help ensure that all predefined packaging process requirements can be fulfilled within predetermined manufacturing limits. OQ evaluation is typically conducted with each type of packaging material used and with each unit of equipment used in the processing of that material. OQ evaluation does not require the inclusion of a medical device within the packaging being evaluated.
• Performance qualification (PQ) - The final qualification step, performance qualification (PQ), evaluates whether the packaging processes consistently produce an acceptable SBS under specific operating conditions. Similar to OQ, PQ evaluation is conducted with each type of packaging material used and with each unit of equipment used in the processing of that material. In PQ, samples from three separate packaging production runs that include the intended sterilization process are evaluated and compared with the predefined requirements for the packaging, for example, appearance, seal width, strength & tightness. However, unlike OQ, PQ evaluation is conducted on the packaging that includes a medical device.
Simply Check the equipment whether it met your requirement.
IQ: Check the specifications given by the manufacturer met your requirement
OQ: Check the working of the equipment by operating it.
PQ: Check the outcome of the equipment met your requirement.