Procurement of Manufacturing Equipment – Standard Operating Procedure
1) Purpose
To establish guidelines for procuring manufacturing equipment to ensure compliance, efficiency, and reliability in production processes within the pharmaceutical purchase department.
2) Scope
This SOP applies to the procurement of manufacturing equipment used in pharmaceutical production facilities.
3) Responsibilities
Procurement Manager: Responsible for overseeing manufacturing equipment procurement.
Engineering Team: Responsible for specifying technical requirements and installation.
4) Procedure
4.1) Equipment Requirement Identification:
4.1.1) Identify equipment needs based on production capacity and technical requirements.
4.1.2) Define equipment specifications including performance criteria and safety standards.
4.2) Supplier Assessment:
4.2.1) Identify potential suppliers capable of providing required manufacturing equipment.
4.2.2) Evaluate suppliers based on technical expertise, quality standards, and delivery capabilities.
4.3) Request for Proposal (RFP) Process:
4.3.1) Prepare and issue RFPs to selected suppliers detailing equipment specifications and project requirements.
4.3.2) Evaluate proposals based on criteria such as technical compliance, cost, and after-sales support.
4.4) Purchase Order and Contract Negotiation:
4.4.1) Negotiate terms and conditions with selected supplier(s) based on RFP evaluation.
4.4.2) Finalize purchase orders and contracts detailing delivery schedules, installation requirements, and warranty terms.
4.5) Receipt, Installation, and Acceptance:
4.5.1) Receive equipment deliveries and verify against purchase orders.
4.5.2) Coordinate installation and commissioning with suppliers and internal teams.
4.5.3) Conduct acceptance testing to ensure equipment meets specifications and safety standards.
4.6) Documentation and Records:
4.6.1) Maintain records of equipment procurement activities including RFPs, purchase orders, installation reports, and acceptance testing results.
4.6.2) Ensure compliance with documentation requirements and regulatory standards.
5) Abbreviations, if any
N/A
6) Documents, if any
- Equipment Specifications
- RFP Documents
- Installation Reports
- Acceptance Testing Records
7) Reference, if any
Regulatory Guidelines: FDA CFR Part 211.63, ICH Q9
Industry Standards: ISO 13485:2016
8) SOP Version
Version 1.0
