ks pharmaceuticals product transfer project plan

8/3/2019 KS Pharmaceuticals Product Transfer Project Plan

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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 theactivities 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, avisit 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


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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.


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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 theOQ 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.


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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 beValidation 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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ks pharmaceuticals product transfer project plan

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