SOP Development Package: Manufacturing Operations
Regulatory Reference: 21 CFR 117.80(c) – Manufacturing Operations
Development of a complete compliance documentation package to standardize safe manufacturing practices, support food safety audits, and mitigate contamination and allergen cross-contact risks in accordance with FDA cGMP requirements.
Deliverables
1. Program Document
- • Overview of cGMP-compliant manufacturing operations
- • Objectives, definitions, and regulatory reference
- • Roles and responsibilities of personnel
2. Policies
- • Contamination control
- • Allergen and cross-contact management
- • Product hold and disposition of adulterated product
- • Temperature and microbial growth control
3. Standard Operating Procedures (SOPs)
Includes SOPs covering:
- • Cleaning/sanitizing of equipment and utensils
- • Temperature control (e.g., cooling, cooking, freezing)
- • Allergen segregation and protection
- • Raw material and rework handling
- • pH/aw control, metal detection, blanching, and more
4. Forms for Records
- • Temperature log sheet (hot/cold zones)
- • Cleaning & sanitizing verification forms
- • Metal detection checklist
- • Adulterated product handling log
- • Allergen storage audit form
- • pH and water activity monitoring log
5. Training Materials
- • Slide decks and visual aids on manufacturing hygiene
- • Training video outline and SOP walkthrough
- • Staff quiz with answer key
- • SOP training acknowledgement form
Fees and Subscriptions
Per Unit Pricing
| Service Component | Price (USD) |
|---|---|
| SOP Development – Per Equipment | $120/unit |
| SOP Development – Per Operational Area | $180/area |
| Product-Type Customization | +$150/category |
| Allergen Control Add-On | +$250 |
| Translation (English to 1 language) | +$300 |
| Annual Review & Update Subscription | +$550/year |
Bundle Package Options
| Bundle Name | Inclusions | Price (USD) |
|---|---|---|
| Starter GMP Bundle | 3 SOPs, 3 forms, 1 policy, basic training kit | $850 |
| Standard GMP Bundle | 5 SOPs, 5 forms, 2 policies, full training kit | $1,450 |
| Advanced GMP Bundle | 8 SOPs, 8 forms, 3 policies, full training kit, 1 product customization | $2,200 |
| Complete Manufacturing Compliance Suite | 12 SOPs, 12 forms, 5 policies, full training, allergen control add-on, 2 product types | $3,200 |
Add-on Services Available Upon Request (e.g., virtual gap audit, label review, allergen risk assessment).