Common questions

What is an installation Qualification?

What is an installation Qualification?

A: The FDA definition of installation qualification is: Establishing confidence that process equipment and ancillary systems are compliant with appropriate codes and approved design intentions, and that manufacturer recommendations are suitably considered.

What is freezer validation?

Validation of freezers which are used to store human samples is required to ensure correct functioning of the unit at the point of installation and to facilitate the ongoing maintenance of sample/tissue integrity during storage.

What is the difference between OQ and PQ?

IQ, OQ, and PQ are sequential activities that manufacturers carry out to validate their manufacturing processes. IQ stands for Installation Qualification, OQ for Operational Qualification, and PQ for Performance Qualification.

What is IQ installation Qualification?

Installation Qualification (IQ) Installation qualification, or IQ, is a documented verification process that the instrument or piece of equipment has been properly delivered, installed and configured according to standards set by the manufacturer or by an approved installation checklist.

Who does installation Qualification?

Installation Qualification (IQ) verifies than an instrument or unit of equipment being qualified (as well as its sub-systems and any ancillary systems) have been installed and configured according to the manufacturer’s specifications or installation checklist.

What is a controlled temperature unit?

A Controlled Temperature Chamber is defined as a system, unit, equipment, or room in which the environmental conditions (usually temperature) of a chamber are controlled, maintained, and regulated to meet specific user requirements.

What is Qualification in GMP?

Qualification is a process of assurance that specific system(s), premises or equipment are able to achieve predetermined acceptance criteria to confirm the attributes what it purports to do.

What is DQ design Qualification?

Design Qualification (DQ) is the documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose, meeting regulatory and process needs.

What is Operation Qualification?

Operational Qualification, or OQ, is an essential process during the development of equipment often used by pharmaceutical companies. OQ can simply be defined as a series of tests which ensure that equipment and its sub-systems will operate within their specified limits consistently and dependably.

What are the qualifications for a freezer validation?

We can customize Freezer Validation protocols to meet each company’s Quality System or execute protocols that the customer already has. Qualifications are a collection of instructions and gathered documentation used in the validation of temperature-controlled units.

What do you need to know about freezer OQ / PQ?

Freezer IQ/OQ/PQ procedures accomplish specific objectives: According to FDA regulations, companies must demonstrate that freezer storage spaces meet temperature requirements. To gain this documentation, a Temperature mapping validation will often be performed, along with the freezer qualifications.

What should the temp be for medicines in the freezer?

This is a very critical range for most of the medicines. Few hours above 2°C or few hours below 8°C will damage the stored medicines. The walk-in freezer for medicines are normally between -18°C and -22°C. However, there are different requirements up to -40°C.

What are the CGMP requirements for the FDA?

Regulatory Education for Industry (REdI): Focus on CGMPs & FDA Inspections Sheraton | Silver Spring, MD | July 15-16, 2015 Facilities & Equipment: CGMP Requirements Regina Brown Senior Policy Advisor CDER/OPQ/OPPQ/DIPAP II Thuy Nguyen, BSN, MPH