Project and Quality Plans

Identification of all activities, critical path, and key milestones (Gantt charts) Recognition and management of project risk Ensnring project prereqnisites are pnt in place Establishment of progress reporting method 

Bndget management, ensnring bnsiness case maintained (beware of scope creep) 

Links to Quality Plan for standards and quality control 

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Preparation of standard procedures Document review Validation glossary Critical parameter assessment GMP criticality and risk analysis Process validation methodology Computerized system validation Preparation of validation plans Preparation of project and quality plans Manufacturing data specification... 

The project validation plan is for individual projects (including equipment) or systems and is derived from the validation master plan. The project validation plan should be closely linked to the overall project and quality plan. 

The overall project itself requires formally structured planning and control in addition to the validation plans for the computerized operation. To provide this, a project and quality plan from the pharmaceutical manufacturer (or its nominated main contractor) is normally developed as a separate and complimentary document and needs to overview all activities, resources, standards, and procedures required for the project. The plan should define project-execution procedures, quality management procedures, engineering standards, project program, and project organization (with authorities and reporting responsibilities), and reference the project validation plan. There are instances in which the project and quality plan and the project validation plan can be combined into one document. 

As part of the supply contract each supplier or subcontractor needs to provide a corresponding project and quality plan to identify and outline the procedures, standards, organization, and resources to be used to align with the requirements of the pharmaceutical manufacturer s project. The contractors and suppliers involved with GMP work should reference the project validation plan and identify the specific requirements that are to be addressed to ensure the appropriate level of documentation in support of the pharmaceutical manufacturer s validation program. 

Project and quality planning by each company is important for multigroup projects, as it enables all those involved in the project—pharmaceutical manufacturer, vendor, or third party—to access a formal definition of project standards, schedule, organization, and contracted responsibilities and monitor interaction at all levels. If elements of the contracted work and supply are to be subcontracted the plan must detail how this work is to be controlled and reported. The supplier project and quality plan must be a contractual document agreed upon by the purchaser and supplier and needs to ensure that ... 

Quality-related critical parameters and data Project and quality plans... 

The main tender document submitted by a vendor will be the FDS, and this needs to include traceability to all specified user requirements. Vendors should also be requested to outline a project and quality plan to identify how they would carry out the project. 

The computer system supplier s detailed project and quality plan incorporating the procedures for software quality assurance should be one of the first contracted deliverables, if not already submitted as part of the quotation or requested during precontract discussions. 

This phase of the supplier s work will be conducted according to the agreed-upon project and quality plan using the supplier s approved procedures, and will involve ... 

Supplier prequalification response Supplier audit report Project and quality plans Software quality assurance plan Commercial and purchasing specs. 

On satisfactory completion of the requirement review and issue of an agreed-upon FDS by the chosen supplier, the design activities can proceed. Throughout design, development, and system build, the supplier, under its project and quality plan, must allow for review of life-cycle activities and documentation in support of the pharmaceutical manufacturer s DQ. 

From this point in the design and development it is normally the supplier s contracted responsibility to lead the review activities and to provide all documentation and information necessary to undertake each review. To best ensure that the requirements detailed during the definition phase are fully covered by system design and development, the key review sessions should have appropriate representation from the groups primarily involved with the system application and operation and should verify adherence to the supplier s project and quality plan. This involvement will afford the pharmaceutical manufacturer a better understanding of the documentation that details how the supplier is meet-... 

Documentation should be subject to review, prior to its formal release. Such a review might assume a number of forms ranging from the evaluation of the docnment and collection of comments throngh to its inspection within formally convened review meetings. The reviewers shonld be identified in advance within the Validation Plan, the Project and Quality Plan, or the docnment management procedures. Many firms give staff guidance on how to decide the most appropriate reviewers for different documents. 

The identity of custodians of controlled copies of documents should be defined in the Validation Plan, the Project and Quality Plan, or the document management procedure. The allocation of released documents to these individuals should be controlled through managed distribution lists. Superseded versions of controlled documents must be replaced in a eomprehensive and timely fashion. Obsolete versions of documents must be clearly marked as superseded. 

Validation Determination Validation (Master) Plan Project and Quality Plan... 

Supplier Project and Quality Plans (for external rather than internal suppliers)... 

Depending on the nature of the Invitation to Tender, the supplier s response may amount to little more than a covering letter with accompanying standard literature. This is often the case for COTS products that the supplier believes meets the user s requirements, or when a dedicated supplier proposal for a more bespoke or customized solution is to follow. Some suppliers may even draft an initial Functional Specification to demonstrate the suitability of the solution they have in mind. Functional Specifications are discussed in detail in Chapter 8. Other proposal documentation might include draft Project and Quality Plans. 

Are project and quality plans produced for projects Who approves them ... 

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