Welcome back to the
Kymanox Midwest Operations Blog.
My last post outlined the commitments made in Validation Master Plans. Of the three listed, the commitment from the management from the organization is one of the most important. This shows that management is dedicated to the outline of how and why
validation must occur; it is also a reflection of the organization's values and objectives.
The Commitment from ManagementA VMP, must first and foremost, contain a commitment to compliance and validation from the management of the organization. The overall commitment from management describes the organization’s values, global objectives, and global approaches for maintaining the validation quality system. Documenting this information is consistent with ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, which states: “The company’s overall policy, intentions, and approach to validation….should be documented.” (1)
Management’s commitment to achieving compliance is a regulatory expectation which can be accomplished through an effective validation program. ICH Q10, Pharmaceutical Quality System (2), 21 CFR § 820.20 (3), and the International Organization for Standardization (ISO) 9001 (4) quality assurance model all refer to the need for a commitment from management in order to achieve compliance. The specific topics included in the policy section of a VMP form the management’s overall commitment to validation.
First, the VMP must broadly define the organization’s values with respect to validation. Just as a child’s values are developed from parents, so too are the values of employees developed from management. Defining the organization’s values regarding validation creates an environment where validation is viewed as an essential quality system. Validation is not simply an activity that is complete when all required tests on the systems have been executed and passed.
Outlining the organization’s values in the VMP is important because it describes the validation philosophy by which the organization operates and monitors its commitment to compliance and validation. Since the VMP is typically requested by inspectors prior to or during an audit, including this information in the VMP demonstrates management’s commitment to validation.
The VMP must also include management’s global objectives for validation. These objectives outline the goals for the validation program. Goals that are written down have a much higher probability of being achieved than those that are not. Goals for validation are no different. Including the objectives for validation in the VMP is a commitment to achieving those goals from the management of the organization.
In addition to including global objectives for validation, the VMP must include global approaches for ensuring that the validation program is both effective and accurate. Every system must be monitored and controlled after implementation to make certain that it continues to operate as intended. A frequency schedule for evaluating validation status shall be applied to each area based on criticality and quality risk. Including a plan for maintaining the validation program re-affirms management’s commitment to validation.
Any comments, questions, and suggestions are welcomed.
Best regards,
Justin Pawlik
REFERENCES
1. ICH, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 04 June 2008.
2. ICH, Pharmaceutical Quality System Q10, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 09 November 2005.
3. Quality System Regulation. Code of Federal Regulations Title 21, Volume 8, Part 820 1 April 2007.
4. ISO 9001:2000 Quality Management Systems—Requirements, Section 4.1.
and know how value-added the training will be for all who attend.
