What to Ask Your Contract Manufacturer For — in Writing

1. Start With Manufacturing Capability

Ask for written confirmation of:

• Product categories
• Dosage forms
• Batch sizes
• Minimum order quantities
• Development capability
• Commercial capacity
• Packaging capability
• Lead times

2. Ask About Quality Systems

Depending on the product, request appropriate information regarding:

• GMP status
• Applicable certifications
• Quality-system scope
• Internal quality controls
• Change control
• Deviation management
• CAPA
• Complaint handling
• Recall procedures

Do not rely only on a certificate image. Understand what the certification actually covers.

3. Define Documentation Expectations

Agree in advance what documents will be supplied. Potential documents include:

• Certificate of Analysis
• Product specification
• Batch documentation
• Manufacturing information
• Testing reports
• Stability information
• Raw-material documentation
• Packaging specifications
• Change notifications

4. Ask How Changes Are Controlled

Important questions include:

• What happens if a raw-material supplier changes?
• What happens if the formula changes?
• What happens if the manufacturing site changes?
• Who approves the change?
• How much notice will the customer receive?
• How are regulatory implications assessed?

5. Define Ownership

Clarify ownership of:

• Formula
• Product specifications
• Artwork
• Product documentation
• Test reports
• Development data
• Regulatory documents

These points should be documented contractually.

6. Quality Should Be Part of the Commercial Discussion

MOQ and price are important. But so are:

• Quality
• Documentation
• Capability
• Reliability
• Change control
• Communication

A manufacturer that looks inexpensive at quotation stage may become expensive if documentation, development or quality issues create delays later.

Conclusion

The best manufacturing relationship starts with clear expectations.

Get the important commitments in writing before the first commercial batch.