Any activity where an expert third party’s economies of scale allow costs to be driven down is ripe for outsourcing. It is more effective and economical to use a reliable partner rather than train and employ in-house experts in fields as diverse as supplier qualification, auditing, calibration, validation and even technology transfer. Overheads are reduced, expertise is maintained, and contractors automatically focus on keeping up with the ever-changing GMP demands of the different regulators around the world.

Validation, qualification and calibration are not just one-off activities. They must be carried out on an on-going basis if a facility’s development, operation and maintenance are going to continue to meet all regulatory requirements. Validation involves the collection and analysis of data in a systematic manner that proves that an analytical method or manufacturing process will give consistent results that meet all specifications when carried out in the prescribed manner. Qualification is the analogous term for equipment and machinery. Installation qualification (IQ) is performed for new equipment, and operation qualification (OQ) and performance qualification (PQ) monitor the day-to-day running of that equipment.

The validation of computer systems must not be overlooked. The computer system validation (CSV) process is used to ensure that all IT applications adequately fulfill their intended purpose. CSV is an important element of the facility’s validation master plan, and all the documentation necessary for equipment must also be prepared for computer systems—much of the data they handle is relevant to a GMP process, and thus, any failure can have a negative impact on product quality. The complexity of such computer systems means an even more in-depth validation process is appropriate, backed up by a methodical risk analysis that allows validation efforts to be focused on the most critical aspects of the system.

All phases of design, development, testing and the software’s routine use must be controlled throughout the lifecycle of a computerized system if it is to remain properly validated. This is particularly important in biopharmaceuticals, as GMP demands specific controls and procedures. CSV includes every activity involved in the application of appropriate controls and procedures throughout the software development lifecycle, and creating all the documentation required by the regulators.

Calibration, meanwhile, is vital in proving and maintaining the legitimacy of qualification and validation. It is designed to show that any instrument or device gives results that fall within specified limits, in contrast to results produced using a traceable standard over a suitable range of measurements. Calibration must be carried out using qualified instruments by an accredited laboratory.

Accurate calibration is essential when building a solid quality management system using experts and qualified specialists. Companies will frequently seek outside support, particularly when upgrading, refurbishing and constructing new facilities, and when sourcing and installing new equipment. These external experts are ideally placed to carry out factory and site acceptance tests. Factory acceptance tests incorporate an inspection, and involve both dynamic and static testing of systems and their major components to support the qualification of equipment. This takes place at the supplier’s site before it is shipped to the end-user. Site acceptance tests, meanwhile, are similar, with the major difference being that they are carried out where the equipment is to be used.

What to look for in an outsourcing partner

The critical nature of validation, qualification and calibration activities makes it essential that the right GMP service provider is chosen. It is a false economy to outsource such an important process to a lower cost company that cannot meet all regulatory requirements. The risk is that those up-front savings will be more than wiped out if they lead to a routine regulatory inspection being failed, or worse, a major product recall.

The following list of questions provides a guide to what a pharma company should be looking for in an outsourcing partner:

• Do they have a strong quality management system?
• Are their technicians and engineers trained and qualified?
• Do they have sufficient equipment of their own, which is maintained and checked in a way that meets GMP requirements?
• Do they guarantee high quality standards in both technical skills and documentation?
• Are they highly responsive to fluctuating workloads at their customers’ operations?
• Are they fully accredited for validation, qualification and calibration by a recognised authority?
• Do they have expertise in IT compliance and validation that meets 21 CFR Part 11?
• Do they offer a range of GMP services, allowing customers to source more than one activity from the same supplier?
• Will they meet all our requirements, while at the same time containing costs?

If the right partner is selected, they can provide vital assistance in maintaining GMP standards, while keeping costs down. Expertise is hard won and takes time and money to maintain, and a focused partner is often better placed to keep those skills and knowledge up to date. CP