Packaging Material Procurement – Standard Operating Procedure
1) Purpose
To define the process for procuring packaging materials used in pharmaceutical packaging to ensure quality, compliance, and availability.
2) Scope
This SOP applies to the procurement of packaging materials within the pharmaceutical purchase department.
3) Responsibilities
Procurement Manager: Responsible for overseeing packaging material procurement.
Purchasing Team: Responsible for executing the procurement process.
4) Procedure
4.1) Packaging Requirement Identification:
4.1.1) Determine packaging requirements based on product specifications and regulatory guidelines.
4.1.2) Verify compatibility of packaging materials with pharmaceutical products.
4.2) Supplier Assessment:
4.2.1) Identify suppliers capable of providing packaging materials that meet requirements.
4.2.2) Evaluate suppliers based on quality, reliability, and cost considerations.
4.3) Purchase Order Creation:
4.3.1) Issue purchase orders to selected suppliers specifying packaging material requirements.
4.3.2) Include delivery schedules and quality assurance requirements in purchase orders.
4.4) Receipt and Quality Control:
4.4.1) Receive packaging materials against purchase orders.
4.4.2) Conduct quality control checks to ensure materials meet specifications.
4.5) Documentation and Records:
4.5.1) Maintain records of packaging material procurement activities including purchase orders, receipts, and quality control reports.
4.5.2) Ensure compliance with documentation requirements.
5) Abbreviations, if any
N/A
6) Documents, if any
- Packaging Material Specifications
- Purchase Orders
- Quality Control Reports
7) Reference, if any
Regulatory Guidelines: FDA CFR Part 211.94, ICH Q9
Industry Standards: ISO 15378:2017
8) SOP Version
Version 1.0