Process Validation Support

A requirement of GMP regulations, the principles of process validation are applicable to all areas of manufacturing industry. Process validation is the means of ensuring and providing documentary evidence that processes (within their specified design parameters) are capable of consistently producing a finished product of the required quality.

The validation of a commercial process to manufacture Active Pharmaceutical Ingredients (APIs) and their intermediates starts during the development process. A number of systems supporting the preparation of APIs for clinical trials must be validated. The data supporting the eventual process validation must be robust and could be inspected by regulatory authorities. For these reasons it is imperative that chemists involved in these activities have a good understanding of the requirements for process validation.

Process validation can often lead to large numbers of samples requiring to be analysed in a rapid manner. Butterworth Laboratories can provide the analytical support to help reduce the impact of these activities on your day-to-day laboratory operations. Sharing the process validation work can help address the question of ruggedness and robustness aspects of method validation. The overall effect is to speed up the process of licence submissions etc.

Examples of work in this area:

• Determination of the levels of residual solvents/ organic volatile impurities
• Residual palladium and platinum levels
• Halogens in carbon based catalysts as part of a recycling process
• Residual CFC & HCFC's from the recycling of refrigerators

Cleaning Validation Support

A requirement of GMP regulations, the principles of cleaning validation are applicable to all areas of manufacturing industry. Cleaning validation is the means of ensuring and providing documentary evidence that processes (within their specified design parameters) are capable of consistently cleaning the equipment used in the manufacturing process so that contamination from previous usage of the same equipment does not effect the final product.

When considering cleaning validation, the first step should be to consider the objective of the validation process. For example, at what point does a piece of equipment or system become clean? Does it have to be scrubbed by hand? What is accomplished by hand scrubbing rather than just a solvent wash? How variable are manual cleaning processes from batch to batch and product to product? The answers to these questions are obviously important to the inspection and evaluation of the cleaning process, since one must determine the overall effectiveness of the process. Answers to these questions may also identify steps that can be eliminated for more effective measures and result in resource savings for the company.

Cleaning validation can often lead to large numbers of samples requiring to be analysed in a rapid manner. Butterworth Laboratories can provide the analytical support to help reduce the impact of these activities on your day-to-day laboratory operations.

Potential contaminants to be considered in cleaning validations include:

• Product residues
• Cleaning agent residues
• Airborne matter
• Lubricants, ancillary material
• Decomposition residues