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KS Pharmaceuticals Product Transfer Project Plan

Following the decision to close the KS Pharmaceuticals UK facility, it was announced that the production of KS1 and KS2 Oral Solutions will be transferred to the Dublin Site. In preparation for this a Project Plan has been developed. This Plan outlines the activities required to achieve the goals of the project within the given timeframe. It also provides information as to the resource requirements for each task. The Dublin site already manufactures a number of oral solution products. KS1 and KS2 are different strengths of the same oral dosage product. The equipment train at the Dublin Site can be used for the manufacture of these new products. A new piece of mixing equipment will be required to be purchased and this will involve a capital purchase which will be included in the project plan.

This project is a serious undertaking for the organisation and it will involve input from a large number of personnel across the site. For this reason the initial task of the project is to set up a project team. This involves meeting with the managers of each area affected to nominate a representative from that area to participate in the project. The main areas involve are Quality, Production, Engineering, Validation, Regulatory Affairs and Environment Health and Safety.

Once the project representatives from each department have been identified the project manager will set up a daily update meeting for each representative to provide feedback to the project manager on the tasks that they are working on. The Project Manager will also use this time to prepare a designated project room for the duration of the project and insure that the workspace is sufficiently equipped to carry out the project work.

Due to the fact that the 2 products that are being transferred from the UK sister plant, a visit of this facility will be arranged so that each departmental representative and the project manager can visualise the task in hand, can obtain expert insight into the process of manufacturing KS1 and KS2 and can build relationships for troubleshooting purposes further down the line. The Project Manager will be responsible for booking

flights, accommodation, hotel transfers and also for arranging meetings and demonstrations with the UK counterparts.

On returning to the Dublin site, the team can commence the main body of the project work. This is split into sections in the project plan. Sections are as follows:

1.

Source Suppliers: Using the valuable information gained at the UK site, a list of suppliers of all raw materials, intermediates & packaging components can be drafted. Potential suppliers can be established and audited. Once a successful audit has been performed the supplier can be added to the Site Approved Supplier List.

2.

Procurement of Mixing Equipment: This part of the project involves the Project Manager working with the Engineering rep to source a supplier for the new mixing equipment. As part of this procurement process a Design Specification document, a Functional Specification document and a User Requirement Specification document are drafted to detail the site requirements in relation to the design, function and use of the mixing equipment. Approval by relevant management is obtained. Vendor is selected at this point.

3.

Documentation: One of the largest sections of work involves the review of existing documentation and the development of new SOPs, Forms, Batch Records, etc. relating to the production of KS1 and KS2 at the Dublin Site. These documents must detail every aspect of production, storage, testing, inspection of KS1 and KS2 oral solutions. 45 Days have been allocated to this activity. This time will need to be carefully managed as the document approval process can usually take more time than anticipated if management have many comments at the review stage.

4.

Method Validation: Existing KS1 and KS2 analytical methods will undergo a method transfer from the UK Site to Dublin. This will involve a team of QC Analysts validating these methods using validated equipment in the QC lab of the Dublin Site. Method validations will be performed on 3 consecutive runs and will test the repeatability, robustness and ruggedness of the methods in producing the required results. All validation protocols will need to be approved within 6 days of the execution of the last validation protocol.

5.

Regulatory Submissions: The regulatory affairs group will be responsible for preparing the regulatory submissions associated with the introduction of the 2 new products to the site.

6.

Equipment Qualification: Once the new Mixer has been purchased and delivered the project team can begin the commissioning and qualification activities for the piece of equipment and any associated instruments. This part of the project will run for 50 days and will involve the engineering and validation project representatives drafting and executing the IQ, OQ ad PQ protocols. Each qualification activity is linked within the project plan. The OQ cannot commence until the IQ has been completed. Similarly, the PQ cannot commence until the OQ has been completed. All deviations will also need to be resolved before moving onto the next stage of qualification.

7.

Cleaning Validation Study and Validation: Once the equipment installation qualification is complete work can begin on the cleaning validation study for the new mixing equipment. These tasks will be performed by a combination of Quality and validation representatives with sampling and analysis performed by lab analysts. This study will involve developing a cleaning method, qualifying a cleaning agent, defining limits for the 2 products using the MACO calculations. This cleaning method will then be validated on 3 consecutive runs and swab samples will be taken to verify the effectiveness of the cleaning process. Once the cleaning method has been verified as effective.

8.

Training: This process will be similar to some of the processes already in place at KS Pharmaceuticals. There will however be a need for significant training throughout the site. This will involve training all relevant personnel on new procedures and work practices. Operators will be trained on the new process and competency evaluation will be performed at regular intervals. QC staff will be trained on all new testing that will be involved as part of the product transfer. QA personnel will be trained on review of batch records and all other documentation relating to the introduction of KS1 and KS2. Management will need training so as to be fully capable of managing the new process within their specific areas.

9.

Process Validation: A process validation will be performed to validate the entire new process. This will be run on 3 consecutive batches. These batches will be Validation batches and will involve some extra testing to be performed by the QC Group. The validation is circulated for managerial approval once it has been fully executed and all deviations have been resolved. Once the QA Group have reviewed all the relevant documentation associated with batches they can be released.

Conclusion: Once all tasks in the project have been completed the oral solution KS1 and KS2 will be ready for full scale production at the Dublin Plant. Production takes place in campaigns and the order of the campaigns is decided by the production scheduling group. KS1 and KS2 will be included in the production schedule for the site once all activities belonging to this project are completed. It is anticipated that the Project will run from 05/05/2010 to the 21/12/2010. It is important that all deadlines are strictly adhered to. With the project finish date set as the 21/12/2010 there is very little room for extension of any dates. The plant will close on the 23/12/2010 for 5 days for Christmas; therefore the project will need to be run to the timelines set out in the project plan.

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