Terms of service

Terms and Conditions for Purchase of Standard Operating Procedures

1. Introduction

These Terms and Conditions ("Terms") govern the sale and use of Good Manufacturing Practice (GMP) and other GxP Standard Operating Procedures ("SOPs") provided by FDA-SOPs.com ("Seller") to the purchaser ("Buyer"). By purchasing or using the SOPs, the Buyer agrees to be bound by these Terms.

2. Scope of Services

The Seller provides SOPs designed to assist pharmaceutical companies in establishing procedures compliant with industry standards. The SOPs are provided as customizable ready-to-use documents in the Microsoft Word .docx format.

3. No Guarantee of Regulatory Acceptance

The Seller does not guarantee that the SOPs will be accepted or approved by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or any other regulatory or health authority. The Buyer acknowledges that:

  • The SOPs are provided as general guidance based on industry best practices.
  • It is the Buyer's responsibility to review, customize, and validate the SOPs to ensure compliance with applicable laws, regulations, and specific regulatory requirements.
  • The Seller is not liable for any rejection, non-compliance findings, or penalties issued by any regulatory authority.

4. Ownership and Use

Upon payment in full, the Buyer is granted a non-exclusive, non-transferable license to use the SOPs for internal business purposes. The Buyer may modify the SOPs to meet their specific needs. The Seller retains all intellectual property rights to the original SOPs.

5. Restrictions

The Buyer agrees not to:

  • Resell, distribute, or share the SOPs with third parties without prior written consent from the Seller.
  • Use the SOPs for any unlawful purpose or in a manner that violates regulatory requirements.

6. Delivery

SOPs will be delivered electronically in the format specified in the purchase agreement. The Seller is not responsible for delays caused by the Buyer’s failure to provide necessary information or access.

7. Limitation of Liability

To the fullest extent permitted by law, the Seller’s liability is limited to the purchase price of the SOPs. The Seller is not liable for any indirect, incidental, consequential, or punitive damages, including but not limited to loss of profits, regulatory fines, or business interruptions, arising from the use or inability to use the SOPs.

8. Disclaimer of Warranties

The SOPs are provided "as is" without warranties of any kind, express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose, or compliance with regulatory requirements. The Buyer assumes all risks related to the use of the SOPs.

9. Indemnification

The Buyer agrees to indemnify and hold the Seller harmless from any claims, damages, or liabilities arising from the Buyer’s use, modification, or implementation of the SOPs, including any regulatory non-compliance.

10. Governing Law

These Terms shall be governed by and construed in accordance with the laws of Colorado, without regard to its conflict of law principles. Any disputes arising under these Terms shall be resolved in the courts of Colorado.

11. Amendments

The Seller reserves the right to update these Terms at any time. The Buyer will be bound by the Terms in effect at the time of purchase.

12. Entire Agreement

These Terms constitute the entire agreement between the Seller and the Buyer regarding the SOPs and supersede any prior agreements or understandings, whether written or oral.

13. Contact Information

For questions or concerns regarding these Terms or the SOPs, please contact Support at fda-sops@outook.com.