Supplier Confidentiality Agreements – Standard Operating Procedure
1) Purpose
To establish guidelines for negotiating, executing, and managing confidentiality agreements with suppliers to protect sensitive information within the pharmaceutical purchase department.
2) Scope
This SOP applies to all interactions and exchanges of confidential information between the pharmaceutical company and its suppliers.
3) Responsibilities
Legal Department: Responsible for drafting and reviewing confidentiality agreements.
Procurement Team: Responsible for implementing and monitoring compliance with confidentiality agreements.
4) Procedure
4.1) Agreement Negotiation:
4.1.1) Identify the need for a confidentiality agreement based on the sensitivity of the information to be shared.
4.1.2) Initiate negotiations with suppliers to establish terms and conditions for protecting confidential information.
4.2) Agreement Drafting:
4.2.1) Draft confidentiality agreements using approved templates and legal language.
4.2.2) Ensure agreements specify the types of information considered confidential and obligations for safeguarding it.
4.3) Execution and Signing:
4.3.1) Obtain necessary approvals for the confidentiality agreement from authorized signatories.
4.3.2) Coordinate the signing of agreements by both parties and maintain executed copies for records.
4.4) Communication and Training:
4.4.1) Communicate confidentiality obligations to relevant stakeholders within the organization.
4.4.2) Provide training on handling and protecting confidential information as per agreement terms.
4.5) Monitoring and Compliance:
4.5.1) Monitor supplier compliance with confidentiality agreements through regular audits and reviews.
4.5.2) Address breaches or non-compliance issues promptly and in accordance with contractual provisions.
5) Abbreviations, if any
N/A
6) Documents, if any
- Confidentiality Agreement Templates
- Executed Confidentiality Agreements
- Training Materials on Confidentiality
- Audit Reports on Compliance
7) Reference, if any
Regulatory Guidelines: FDA CFR Part 211.22, GDPR
Industry Standards: ISO 27001:2013
8) SOP Version
Version 1.0