Follow
1.0 OBJECTIVE
To ensure that Beximco products are manufactured by the contractor using facilities and operations that conforms to cGMP requirements.
2.0 SCOPE
The SOP is applicable for all products of (Company Name) manufactured & packed in a third party contract manufacturer.
3.0 RESPONSIBILITY
3.1 Quality Assurance of (Company Name) is responsible to review the facilities & GMP status of the third party contract manufacturing site and to give approval of the site.
3.1.1 Head of QA shall be responsible for training and execution of procedure.
4.0 ACCOUNTABILITY
4.1 Executive Director, Quality.
5.0 PRECAUTIONS
Not Applicable.
6.0 PROCEDURE
6.1 Carry out GMP audit to assess the prospective contractor’s technical capability, capacity, cost effectiveness & the capability to maintain the required standards of cGMP & product quality.
6.2 Document the business objectives and the justification for selecting a third party contractor.
6.3 Review the manufacturing strategy which will be applied to the third party contractors.
6.4 After developing a third party contract manufacturer, provide the product and their volume to the third party contractor for its technical assessment of manufacturing capability.
6.5 Multiple strategies to be followed in selecting third party contractor.
6.6 Identify the issues in implementing project.
6.7 Identify any capital investment required for implementing the project.
6.8 Consider the sources of materials which must meet the approved specification.
6.9 Sign a contract manufacturing agreement with the selected contractor for manufacturing / packaging of products.
