However in practice, depending on the project, it has been shown to be useful to work with a qualification master plan in the same way as with a validation master plan. From the regulatory perspective there are two documents including references to the content of a VMP/QMP:
In addition, the German GMP inspectorates published an Aide mémoire on the inspection of qualification/validation that contains useful advice on the expected content of the QMP.
1.4 The key elements of the site qualification and validation programme should be clearly defined and documented in a validation master plan (VMP) or equivalent document.
1.5 The VMP or equivalent document should define the qualification/validation system and include or reference information on at least the following:
i. Qualification and Validation policy;
ii. The organisational structure including roles and responsibilities for qualification and validation activities;
iii. Summary of the facilities, equipment, systems, processes on site and the qualification and validation status;
iv. Change control and deviation management for qualification and validation;
v. Guidance on developing acceptance criteria;
vi. References to existing documents;
vii. The qualification and validation strategy, including requalification, where applicable.
4.1.1 Validation in general requires a meticulous preparation and careful planning of the various steps in the process. In addition, all work involved should be carried out in a structured way according to formally authorised standardised working and administrative procedures. In addition validation is characterised by:
4.1.2 The above factors require a well organised and structured approach that should be adequately described in a Validation Master Plan (VMP).
4.2.1 The VMP should present an overview of the entire validation operation, its organisational structure, its content and planning. The core of the VMP being the list/inventory of the items to be validated and the planning schedule.
4.2.2 A VMP helps management:
A VMP helps all members of the validation team:
A VMP helps GMP inspectors:
4.3.1 A Validation Master Plan is a document that summarises the firm's overall philosophy, intentions and approach to be used for establishing performance adequacy.
4.4.1 All validation activities relating to critical technical operations, relevant to product and process controls within a firm should be included in a VMP. This includes qualification of critical manufacturing and control equipment.
4.4.2 It should comprise all Prospective, Concurrent, Retrospective Validations as well as Re-validations.
4.4.3 In case of large projects like the construction of a new facility, often the best approach is to create a separate VMP. (In such situations the VMP should be part of the total project management.)
4.5.1 The VMP should be a summary document and should therefore be brief, concise and clear. It should not repeat information documented elsewhere but refer to existing documents such as Policy Documents, SOP's and Validation Protocols/Reports.
The VMP should be agreed by management.
4.5.2 A VMP should contain data on the following subjects / proposed chapters.
188.8.131.52 Firm's validation policy, general description of the scope of those operations covered by the VMP, location and schedule (including priorities).
184.108.40.206 Personnel responsibility for
220.127.116.11 Provides a cross reference to other documents. A rationale for the inclusion or exclusion of validations, for the validation approach and the extent of validation should be included.
|Note: A common principle in validation studies is to challenge processes, systems etc. The rationale behind any challenge and or ”worst case” situation should be explained. Consideration can be given to the grouping of products/processes for the purpose of validating “worst case” situations. Where “worst case” situations cannot be simulated, the rationale for the groupings made should be defined.|
18.104.22.168 Under this heading specific characteristics/requirements of the plant/ process etc. that are critical for yielding a quality product and need extra attention may be briefly outlined here.
22.214.171.124 All validation activities comprised in the VMP should be summarised and compiled in a matrix format. Such matrix should provide an overview and contain:
126.96.36.199 General statement on key acceptance criteria for the items listed under (188.8.131.52) above.
184.108.40.206 The format to be used for protocols and reports should be described or referred to.
220.127.116.11 List of relevant SOP's should be presented.
18.104.22.168 An estimate of staffing (including training needs), equipment and other specific requirements to complete the validation effort should be described in the VMP. A time plan of the project with detailed planning of subprojects. This time plan could be included in the above mentioned matrix (22.214.171.124). A VMP requires regular updating.
126.96.36.199 A statement of the company's commitment to controlling critical changes to materials, facilities, equipment or processes (including analytical techniques), should be included.
3.3.2 Validation Master Plan (VMP)
The validation master plan contains the qualification and validation projects of the manufacturer. It enables the GMP inspector to understand the company's approach to qualification and validation, the definition and organisation of the required activities. The manufacturer shall individually define the required qualification and validation activities and describe them in a VMP.
Components of the validation master plan shall be:
Cross-references to existing documents are permissible. Although not required by the regulations, some companies distinguish between a Qualification Master Plan (QMP) and a Validation Master Plan (VMP). The requirements for a VMP apply analogously to the QMP; however, the latter only considers qualification projects. Such a division can be quite useful to ensure greater clarity and timeliness of these overarching documents, especially in complex projects. Clear referencing is mandatory.
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