Follow
1.0 OBJECTIVE
To ensure that all batches of product manufactured at third party contract manufacturer undergo a formal agreement and evaluation of suitability for use prior to release to the market.
2.0 SCOPE
The SOP is applicable for contract manufacture and release the product batches manufactured and packed in a third party manufacturer (Third Party Contractor).
3.0 RESPONSIBILITY
3.1 Third party contractor shall be responsible to perform analysis of the manufactured & packed product as per the approved specification & Standard Testing Procedure and prepare certificate of analysis (CoA).
3.2 QA of (Company Name) is responsible to review the documents (including CoA) received from third party manufacturer.
3.3 Overall responsibility of the product release is with the Head of Quality of (Company Name).
4.0 ACCOUNTABILITY
4.1 Executive Director, Quality.
5.0 PRECAUTIONS
NA
6.0 PROCEDURE
6.1 There shall be a written contract between the contract giver and the contract acceptor which clearly establishes the duties of each party.
6.2 The contract shall clearly state the way in which the authorised person releasing each batch of product for sale exercises his full responsibility.
6.3 The Contract Giver
6.3.1 The contract giver shall be responsible for assessing the competence of the contract acceptor to carry out successfully the work required and for ensuring by means of the contract that the principles and guidelines of GMP as interpreted in this guide are followed.
6.3.2 The contract giver shall provide the contract acceptor with all the information necessary to carry out the contracted operations correctly in accordance with the marketing authorisation and any other legal requirements.
6.3.3 The contract giver shall ensure that the contract acceptor is fully aware of any problems associated with the product or the work which might pose a hazard to his premises, equipment, personnel, other materials or other products.
6.3.4 The contract giver shall ensure that all processed products and materials delivered to him by the contract acceptor comply with their specifications or that the products have been released by an authorised person.
6.4 The Contract Acceptor
6.4.1 The contract acceptor must have adequate premises and equipment, knowledge and experience, and competent personnel to carry out satisfactorily the work ordered by the contract giver.
6.4.2 Contract manufacture shall be undertaken only by a manufacturer who is the holder of a manufacturing authorisation.
6.4.2 The contract acceptor shall ensure that all products or materials delivered to him are suitable for their intended purpose.
6.4.3 The contract acceptor shall not pass to a third party any of the work entrusted to him under the contract without the contract giver’s prior evaluation and approval of the arrangements.
6.4.4 Arrangements made between the contract acceptor and any third party shall ensure that the manufacturing and analytical information is made available in the same way as between the original contract giver and contract acceptor.
6.4.5 The contract acceptor shall be refrained from any activity which may adversely affect the quality of the product manufactured and/or analysed.
6.5 Release of product batches manufactured at third party contract manufacturer
6.5.1 Product manufactured at the third party contractor will be tested at the end of the third
party contract manufacturer’s laboratory as per the approved specification.
6.5.2 Third party contract manufacturers site will provide Beximco Pharmaceuticals Limited
with full batch documentation (for the first thee batches), copies of any unplanned event or deviation (including OOS), a copy of any investigation reports and CoA reporting analytical test results against specification.
6.5.3 Alternatively, Head of Quality and Head of manufacturing will be present during the manufacturing / packaging of the first three batches and in that case CoA will be reviewed by the Executive Director, Quality of Beximco Pharmaceuticals Limited before release of the batches.
6.5.4 Executive Director, Quality of Beximco Pharmaceuticals Limited will release the batches based on the satisfactory review of CoA.
6.5.5 Executive Director, Quality of Beximco Pharmaceuticals Limited will send notification to the third party contract manufacturer (via Fax or e-mail) about the review of CoA & about the batch disposition decision.
6.5.6 Upon receiving the batch disposition decision from Executive Director, Quality of Beximco Pharmaceuticals Limited, the third party contract manufacturer will either
ship the product batches to the importing country (if found satisfactory) or take step accordingly.
