Trying to remain compliant with the current Good Manufacturing Practices (cGMP) has its challenges and opportunities. I would like to discuss the opportunity afforded by the ASTM E2500 "Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment". One of the problems that some clients have had to address is how to move from the traditional IQ / OQ/ PQ system to one that is science and risk based.
We have been successful by applying a 3 tiered model. Most pharmaceutical and biopharmaceutical companies have an overarching policy document that general describes their philosophy and approach to commissioning (verification), qualification and validation. Sometimes this policy is restrictive and does not allow for any variations for the validation approach. This is the first level that needs to be changed. We have found that a revision at this level can allow alternate approaches. Getting Quality Assurance buy-in at this level is a must. It will set the stage for the kinds of testing that can be leveraged, the requirements for the leveraged testing, and the testing that must be conducted in the qualification documents.
The next level is the Master Validation Plan or Standard Operating Procedure level. These often prescribe the validation documents from a style, format and content perspective. The changes at this level are often more critical in that they can enable a different approach, but maintain the controls on the design and execution of the specific testing. A thorough revision can be challenging but is necessary to get to the third level.
The third level is the protocol level. This level will set the requirements to conduct the testing in very specific ways. Once the policy (allow) and planning (enable) levels have been changed, the protocols can be written and executed to complete the package and bring all of the commissioning testing and qualification testing together in the final package. Obviously, training throughout this process is needed for the understanding of when, where, how, and who does what testing, but the savings in time and cost are significant.
ProPharma Group has been successful in developing this approach and we are available to discuss any specific questions or needs that you may have.
April 2, 2015
The most recent FDA report (FY2010) said the third highest reason a 483, warning letter, or consent decree was issued was because of discrepancies and/or failures in investigations due to inadequate...
April 2, 2015
The commissioning process is defined as "a quality-focused process for enhancing the delivery of a project. The process focuses upon verifying and documenting that all of the commissioned systems and...