- The purpose of this SOP (Standard Operating Procedure) is to describe the procedure for the preparation and handling of all technical agreement (s).
2.0 SCOPE:
- This procedure is applicable to handling technical agreements at pharmaceutical plants.
3.0 REFERENCES:
- In House
- WHO TRS: 961
4.0 RESPONSIBILITY:
Quality Assurance shall be responsible –
- To prepare a list of documents of Technical Agreements and retain one copy of such document.
- Review the list periodically and ensure that all agreements getting due are reviewed and revised.
User Department shall be responsible –
- To prepare and revise the agreement as per SOP.
- To evaluate or audit the external party before signing any agreement.
- Intimate and provide a copy of the technical agreement to QA for review and retention purposes.
- Review and renew the agreement before they are getting due.
5.0 PROCEDURE – TECHNICAL AGREEMENT:
- QA shall ensure that for all technical services or any other services which have co-relation with GMP activity and are availed from an outside agency, shall be through a formal agreement that clearly defines the role and responsibilities of both the parties.
- Contract analysis must be correctly defined, agreed, and controlled in order to avoid any misunderstanding, by defining the responsibilities and communication processes for quality-related activities of the parties concerned.
- The giver (contract) shall be responsible for assessing the competence of the contract acceptor by successfully carrying out the work or tests required, for approval of contract activities or any other legal requirements.
The contract should permit the contract giver to audit the facilities of the contract acceptor.
- The giver (contract) shall be responsible for monitoring and review of the performance of the contract acceptor or the quality of the material from the provider, and identification and implementation of any improvements needed.
- The contract acceptor must have adequate premises, equipment, analytical instrument, knowledge, and experience of competent personnel to carry out satisfactorily the work ordered by the contract giver.
Each technical agreement shall contain a clearly defined
- Scope of agreement,
- Role & responsibility of both the parties,
- The time period for which the agreement shall be effective, and
- Conditions in which the agreement shall cease automatically or terminated by any of the parties.
- All Technical agreements shall be prepared by the user department and representative of the service provider and shall be signed by the appropriate authority from both parties.
- QA may or may not be the signing authority but shall be the overall controlling authority for all GMP-related issues.
- If required, such an agreement can be prepared on appropriate stamp papers.
- Approval by the legal department shall be taken, if required.
- The contract giver should ensure that the contract acceptor is fully aware of any problems associated with the product, work, or tests that might pose a hazard to premises, equipment, personnel, other materials, or other products.
- The contract giver should provide the contract acceptor with all necessary information to enable compliance with expectations regarding services or goods.
This assures that the work or service is performed in compliance with existing regulations.
- The contract acceptor should not pass to a third party any of the work entrusted to him or her under the contract without the contract giver’s prior evaluation and approval of the arrangements.
- Technical Arrangements made between the contract acceptor and any third party should ensure that the testing and analytical information is made available in the same way as between the original contract giver and contract acceptor.
- T he contract acceptor should refrain from any activity that may adversely affect the quality of the product manufactured and/ or analyzed for the contract giver.
- For providing technical services vendor shall be selected based on the overall evaluation of the party and only competent parties shall be assigned with such responsibilities.
The contract:
- There must be a written contract between the contract giver and the Contract acceptor which clearly establishes the responsibilities.
- Technical aspects of the contract should be drawn up by competent persons suitably knowledgeable in pharmaceutical technology, analysis, and GMP.
- All technical arrangements for analysis and calibration/ validation must be in accordance with the marketing authorization and agreed upon by both parties.
- The technical agreement shall not bear the commercial terms.
- However, if included, those terms shall not be binding from GMP’s perspective.
- QA shall prepare a list of such technical documents for review and signed on the agreement copy and also retain a copy of such document.
Following are the services, but not limited to, for which agreement should be available if the services are received from an outside agency.
- The Technical Agreements for HVAC qualification.
- The Technical Agreements for compressed air testing.
- Agreement of Operation and maintaining the quality of treated effluent water and assistance for pollution control-related matter.
- Technical Agreement for water storage tank cleaning.
- Agreement for medical check-up.
- Contract for pest and rodent control.
- Agreement for maintaining fire extinguisher cylinder.
- Agreement for supplying labor on a contract basis.
- Technical Agreement for vigilance services/security.
- Agreement between company and service Provider Company/ agency for servicing and calibration of Equipment and Instruments.
- Agreement with Medical Practitioner for providing Medical facility.
- Technical Agreement for contract Lab for analysis (Both Internal and External).
- Agreement with transporters and Courier agencies.
- QA shall review the list periodically and ensure that all agreements getting due are reviewed and revised.
- The following format can be used for the preparation of the Technical Agreement.
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Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]
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