Qualification validation master plan

Berg, T., Humphreys, P., Phillips, B. and Scherz, B., Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation , PIC Publication PH 1/96. 

To provide the guideline for the preparation of validation master plan to meet the design qualification requirement... 

For larger projects, an individual validation project plan should be developed. This plan is derived from the validation master plan. It formalizes qualification and validation and outlines what has to be done to get a specific system into compliance. For inspectors it is the first indication on the control that a laboratory has over a specific computerized system, and it also gives a first impression of the validation quality. 

It is important to draw up a summarized document that describes the whole project. It has become common practice in the industry to develop a validation master plan (VMP). This document would usually include the qualification aspects of a project. Alternatively, a qualification master plan (QMP) should be drafted. In case of a large retrospective qualification project it is beneficial to write a separate QMP. The main point is to develop a document that includes the most important information of the project and can be used like a project handbook. 

In the following text an attempt is made to give an example of the types of documentation that must be prepared within the validation master plan for the design qualification (DQ), the installation qualification (IQ) and the operational qualification (OQ). Performance qualification (PQ) should follow the successful completion of installation qualification (IQ) and operational qualification (OQ). 

At the beginning of any qualification and validation, a validation master plan (VMP) must be worked out. The FDA defines validation plan< as a validation proto-col< (guideline of principles of general process validation) [6.7]. 

Validation Master Plan Design Qualification Installation Qualification Operational Qualification Performance Qualification Validation Reports... 

The validation of a PLC cannot be viewed as a stand-alone operation. PLCs are there for a purpose — to provide automotive functionality. A project Validation Master Plan that details what other validation (equipment qualification, validation of other automated systems) is required. An overall project plan timetable must be in place in order to ensure, e.g., that validation of the PLC does not adversely delay the qualification of important equipment. Where the PLC is to communicate with another PLC embedded into an item of equipment, the link as well as the validated, as well as the individual PLCs, but the link cannot be validated until the software processing the information from the particular I/O point is validated. The deflnition of the boundaries of each validation prevents unnecessary duplication. For PLCs, it is best to use the I/O cards as the boundary. A final check from HMI to the device can then be performed to ensure the system works in its entirety. 

Most basic validation activities within the cGMP pilot plant are identical to those expected in practice in a manufacturing facility. A validation master plan should be developed that addresses the design specifications and qualification, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of all major utility systems, process equipment, and computer control systems. Installation and commissioning data should be retained as part of an engineering documentation package. A workable... 

The qualification of the HVAC system should be described in a validation master plan (VMP). 

Validation master plan design qualification, installation and operational qualification, non-sterile process validation, cleaning validation. EU document 111/5581/99. European Commission, Working Party on Control of Medicines and Inspections, Brussels, 1999. 

This Validation Master Plan (VMP) specifies and coordinates all qualification/validation activities to ensure the production of pharmaceutical products according to accepted international standards. It also specifies the responsibilities for validation procedures and helps to plan the necessary activities. 

The Validation Master Plan (VMP) includes all relevant aspects relating to the production of pharmaceuticals in the production facility at ABC Pharmaceutical. The principles of validation, the organization of qualification and validation, and the design and nomenclature of the documentation and equipment are also described. The VMP covers all facilities used in the production of tablets, liquids, ointments, creams, suppositories, and sterile products the facilities for storing raw materials, interim and finished products, storage, services, and the rooms for staff. 

All necessary activities and responsibilities for the qualification and validation are controlled and specified in this Validation Master Plan. Every step of the described validation program for facilities, equipment, processes, process controls, and cleaning is in accordance with the current European Community Guidelines for GMP and FDA, and the cGMP guideline for finished pharmaceutical manufacturers. All requirements in these directives are fulfilled in this validation process. 

Each prospective validation step will be described in Qualification/Validation documents. In these documents, except for the Validation Master Plan and the Validation Report, the test methods for validation and acceptance criteria for the results are specified. Also described are whether the equipment has to be prepared for the test method and whether the original status of the equipment has to be restored after testing. 

In this Validation Master Plan, Chapter 9 shows the qualification matrix. This matrix indicates the processes and parts of the plant for which an RA must be produced. 

The purpose of a numbering system for the documentation is to ensure an unambiguous identification of each validation/qualification document produced within the field of application of the Validation Master Plan. The document number is a combination of letters and numbers with a length of 10 or 11 characters. An example of such a document number might be ... 

Validation master plan Specification Risk analysis Design qualification Installation qualification Operational qualification Performance qualification Validation report Process validation plan Process validation program Cleaning validation plan Cleaning validation program Computer validation plan... 

Project description What is a Validation Master Plan Scope of Validation Master Plan Definition for the term validation Validation team member Validation team responsibility Concept of qualification/validation Fundamentals... 

For example, a company which experienced a customer complaint involving a large glass fragment in an aseptically filled powder vial introduced procedural preventive measures but concluded that the issue required automated vision inspection equipment. Once the corrective equipment was identified, a validation master plan detailed the key qualification elements for hardware, software, defect detection system, infeed/outfeed links, but also the specification requirements of the component and component quality, e.g ... 

The validation life cycle is basically split into six main qualification phases as shown in Table 9.2 and all under the control of the Validation Master Plan (VMP). It must be clearly demonstrated that the QA function of the pharmaceutical manufacturer is endorsing the implemented system. In its simplest form, this will require the QA representative to authorize the documentation produced to support validation (e.g., VMP, Source Code Review, qualification documentation, reports, etc.). Table 9.2 shows the linkage between project activities and the qualification process, which is under the control of the VMP. 

A validation master plan that contains concepts of qualification, requalification, risk assessment, validation, maintenance, periodic inspections, and system retirement is kept. 

The documents described, namely, System Qualification Procedures (SQPs) and Standard Operating Procedure (SOP) in Figure 1 contain a generic risk assessment for determination of the validation scope and effort on the equipment lyophilizer. They were also used as a generic validation master plan for the project. Management of the project resources, costs, and deadlines was performed with a model created in a standard project planner. 

Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-operation Scheme. Recommendations on validation master plan - installation and operational qualification - non-sterile process validation - cleaning validation. PI 006-3. 2007. http // www.picscheme.org/publication.php p=guides. Accessed 4 Sept 2014... 

The validation process is subject to the following design specifications, user and performance requirements, preparation of a master plan/validation protocol (installation qualification, operational qualification, and performance qualification), execution of the protocol, preparation of a summary report, and on-going validation (and revalidation if changes are made). 

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