Pharmaceuticals process validation operational qualification

This chapter defines the terms, responsibilities, requirements and recommended procedures involved in pre-installation, installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), which are all part of a typical HPLC system validation process. As the FDA does not publish a definitive reference or cookbook for these procedures, the suggestions herein are only recommendations. These have been successfully incorporated into formal standard operating procedures (SOPs) that have been implemented at a number of larger pharmaceutical establishments. As long as proper SOPs... 

Figure 1 depicts the most commonly used approach to the qualification process as used in the pharmaceutical industry. It shows a pyramid, which is the best way in which to plan a qualification/validation project. Investing more time in the first phases will save time and money in later and critical phases. If inadequate investment is made during the start-up of a project, the later phases of installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) will necessarily require an inordinate amount of time and money. The project will be a pyramid again, but now it is inverted. 

Recommendation on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation and Cleaning Validation, Pharmaceutical Inspection Co-Operation Scheme PIC/S PI 006 (2002). 

On satisfactory completion of the computer system qualifications, with PQ conducted in conjunction with a successful process validation, a final report must be prepared by the pharmaceutical manufacturer s validation team. This is normally referred to as the validation report. The objective of the report is to give an overview of the results of the execution of the validation program for the computerized operation and to draw a conclusion as to the suitability of the computerized operation for pharmaceutical manufacturing. This may be unconditional use or there may be restrictions. In the latter case the proposed remedial ac-tion(s) must be approved and, as applicable, considered under change control. A schedule to complete any outstanding actions must be documented and progress formally reported. 

Validation is described as proof that the system performs as stated. As an engineering control, the LAF system must demonstrably support the intended aseptic or controlled process. Validation of the aseptic manufacturing process and the LAF systems that support terminal sterilization in pharmaceutical manufacturing applications should be carried out in accordance with industry standards. Such validation should be accomplished in three phases, consisting of installation qualification (IQ), operational qualification (OQ), and process qualification (PQ), with full and detailed documentation of all activities and... 

Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-operation Scheme. Recommendations on validation master plan - installation and operational qualification - non-sterile process validation - cleaning validation. PI 006-3. 2007. http // www.picscheme.org/publication.php p=guides. Accessed 4 Sept 2014... 

Installation Qualification After equipment selection, it is necessary to assure that the equipment is installed well. The IQ document describes and validates the procedure of the equipment installation. It establishes confidence that the process equipment and ancillary systems are capable of consistently operating within established limits and tolerances [10]. The equipment manufacturer and pharmaceutical company must agree and check the IQ, which must be approved by the pharmaceutical company at the end. This document certifies that equipment was installed as specified by the manufacturer and the purchaser. 

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