Pharmaceutical manufacturers have an obligation to ensure that their manufacturing equipment is properly designed, installed, tested, operated, and maintained throughout their service lifetimes. During these service lifetimes manufacturing equipment will likely require both preventive and corrective maintenance activities that may involve the replacement of parts within the systems. Parts replacements must be performed under the appropriate change controls to ensure that manufacturing equipment remains in a validated state with respect to installation, operation, and performance. Change control considerations are greatly facilitated when replacement parts are exactly identical to the original parts. However, it is not uncommon for pharmaceutical manufacturers to resort to procuring and installing replacement parts that are not identical to the original parts due to changes affected by parts suppliers (product redesigns, discontinuations, etc.). In these instances, a risk management approach may be utilized to systematically assess whether replacement parts are functionally equivalent (also referred to as like-to-like) with original parts in order to ensure proper change control while also preventing unnecessary revalidation activities.
A risk management approach was taken by the firm to identify the following:
- Risks associated with equipment parts changes that might adversely impact the validated state of manufacturing equipment.
- Risks associated with the process of determining whether original and replacement parts are functionally equivalent.
- Proper roles and responsibilities of the functional areas involved in the process of determining whether original and replacement parts are functionally equivalent.
The outputs of the risk management approach utilized by the firm included a generic, robust, and repeatable process for performing functional equivalence assessments as well as definition of organizational roles and responsibilities supporting the process.
The following observations regarding the process that had historically been used for replacement parts functional equivalence determinations:
- The functional equivalence assessment process was historically dependent upon human judgment, expertise, and experience.
- Process risks (potential breakdowns of the process) were qualitative in nature and were difficult to quantify with specificity.
Equivalency report: Equipment, which is similar in design, capacity, operating principle, operating procedure and cleaning procedure, shall be evaluated to prepare equivalency report.
Preparation of Equivalency Report: Equivalency report shall be prepared by comparing the equipment on the following, but not limited to;
Equipment operating principle.
Equipment details as below but not limited to
- Capacity / volume (working)
- Speed / RPM of functional components if applicable for example: Speed of chopper etc.
- Type of tooling or change parts for major components. For example: Type D or B type of tooling.
- Significant design parameters of equipment for example, RMG-Volume in liters, Agitator speed, chopper speed. For Extrusion and Spheroidization –RPM range of roller /screw conveyor, hole size etc. For Fluid bed processing (FBP/FBE): Spray nozzle size, number of spraying guns, number of Wurster column etc. Compression press: Type of tooling, type of feeding etc. Encapsulation: Suitable change parts, capsule filling principle etc.
- Model / Manufacturer: for data capture.
- Applicable SOP if any difference exists, it will be listed separately.
- Statement that general principle of operating and cleaning are similar except variation to size etc.
After comparing details, draw conclusion on similarity of equipment and prepare justification summary.