| Handling of Out Sourced Activities |
1.0 OBJECTIVE To lay down the procedure for handling of outsourced activities. 2.0 SCOPE This procedure is applicable for outsourced activity / work. This SOP is not applicable to outsourced activity for civil, construction, repairing & maintenance work. 3.0 RESPONSIBILITY • User Department Officer/ Executive • Respective Department Head 4.0 ACCOUNTABILITY Head Quality / QA To Read this SOP Click here SOP for In-Process Quality Checks during Filling and packing. 5.0 PROCEDURE 5.1 The outsourcing is defined as any work or activity, which is not performed directly by the XXX employee at the facility of XXX. 5.2 The outsourcing of any activity / work shall be done only in exceptional cases where required resources for performing the activity is not available or could not be made available temporarily or permanently. 5.3 The outsourced activity shall be appropriately defined, agreed and controlled in order to avoid misunderstandings between the XXX (contract giver, CG) & external agencies (contract acceptor, CA), which could result in a product or operation of unsatisfactory quality. 5.4 Prior to outsourcing activities, the XXX should assess the legality, suitability and the competence of the Contract Acceptor to carry out successfully the outsourced activities. The XXX should also ensure by means of the contract that the principles and guidelines of GMP are followed. 5.5 XXX should provide the CA with all the information and knowledge necessary to carry out the contracted operations correctly in accordance with regulations in force. 5.6 The XXX should explain the CA of any problems associated with the work / instrument / equipment which might pose a hazard to his premises, equipment, personnel, other materials or other products during the initial assessment & discussion with CA. 5.7 Where applicable XXX should review and assess the records and the results related to the outsourced activities. 5.8 While outsourcing any activity XXX shall inform CA to follow the below guideline but not limited to: 5.8.1 The CA should not subcontract to a third party any of the work entrusted to him under the contract without the XXX prior evaluation and approval of the arrangements. 5.8.2 The CA should not make any unauthorized changes, outside the terms of the contract, which may adversely affect the quality of the outsourced activities for the XXX. 5.8.3 The facility of CA may be subjected to inspection by the national and / or international agencies. 5.9 There should be a written Contract covering the outsourced activities, the products or operations to which they are related, this contract shall be referred as Technical Agreement (TA). 5.9.1 The Contract should permit the Contract Giver to audit outsourced activities, performed by the Contract Acceptor or his mutually agreed subcontractors. 5.9.2 The TA shall be prepared as per Format no. YYY & it shall be signed by both parties CA & CG. The content of text under the different sections of Format no. YYY may vary depending on the activity out sourced. 5.9.3 The TA shall be reviewed on every three (3) years to ensure all applicable term & conditions are part of TA and followed. If required TA shall be reviewed & updated need based also. 5.9.4 The TA shall be effective after signing of both the parties & it shall be reviewed before three (3) years. If TA is not reviewed post six (6) month of review before date, TA stands cancelled. 5.9.5 The format no. YYY shall also be used for preparing the TA with raw material & packing material manufacturer & supplier. If required, mutually agreed changes can be done in the format at the time of preparing the TA. 5.9.6 Assessment of outsourcing agency shall be done by XXX as per format number YYY & if agency complies the criteria, TA shall be signed. 5.9.7 CA shall be included in the approved CA list based on satisfactory evaluation & signing of TA. 5.10 XXX has identified following activity to be performed by external agencies but not limited to : • Pest control • Analysis of material • Disposal of scrap • Laundry • Calibration & validation • Transportation • Stereo supplies • Supplies of gas/diesel 5.11 List of outsource activities shall be prepared as per Format no. YYY & it shall be reviewed annually for updation. If there is any addition or deletion of outsourced activity the list shall be updated accordingly. 5.12 For Quality Agreements, Qualified/Quality Person (QP) of XXX shall authorize to sign the agreement. 5.13 For other than Quality Agreement like commercial aspects, Supply chain or purchase department, authorize person of concerned section shall sign the agreement. 5.14 The TA for contract analysis shall be prepared as per format no. YYY and all other details along with & Terms & Conditions shall be followed as per SOP no. ZZZ. 5.15 TA with PL holders shall be prepared as per recommendation by PL holder or their format with all relevant details, Terms & condition. 5.16 During period of TA, if any non-compliance observed with respect to clauses of TA, same shall be discussed with the CA and matter shall be resolved. 5.17 All TA shall be numbered as per prototype SSG/DD/TA/NN, Where, SSG : stands for XXX DD : stands for two alphabet department code TA : stands for Technical Agreement NN : stands for sequential serial number of the TA, (01, 02, 03…and so on) 5.18 When the TA is signed first time, its version number shall be assigned as 00. On subsequent revision it shall be assigned as 01, 02, 03 ….and so on. 5.19 NOTE XXX – Company name YYY – Format Number |
