PETS Position Paper

Process Engineering & Technical Operations Services

PETS Functional Scope

PETS

Functional Responsibilities (Revised)
Technical Feasibility Governance
AI-assisted screening rules + escalation thresholds
Technical Material Sourcing
Ingredient specs, attributes, and acceptable supplier definition
Bench Process Development
Manufacturability assessment + early parameter discovery
Formulation Scale-Up Engineering
Manufacturing-focused formulation adaptation (not PD invention)
MMR Engineering
Drafting technical manufacturing instructions for QU approval
Process Engineering (Design & Optimization)
Process design, CPP definition, troubleshooting, continuous improvement
Validation Engineering Support
Protocol input + data interpretation in support of QU governance

Note: In a small-shop execution model, Production executes pilot batches under controlled documentation, with PETS interpreting outcomes and the Quality Unit independently governing approval, change control, and disposition.

This document defines the scope, authority, and responsibilities of the Process Engineering & Technical Operations Services (PETS) function. The purpose is to align Commercial, Product Development, Production, Procurement, and the Quality Unit on how technical manufacturing processes are designed, specified, validated, and maintained.

PETS serves as the technical backbone of manufacturing, ensuring that products can be produced safely, consistently, and compliantly within the facility's operational capabilities.

Core Principle

Product Development defines what the product is.
PETS defines how the product is manufactured.
Quality independently governs compliance, documentation approval, and product disposition.
Production performs the execution of manufacturing.

Manufacturing Lifecycle Overview

Commercial Opportunity ↓ Technical Feasibility Governance (AI-assisted screening) ↓ Bench Process Development ↓ Formulation Scale-Up Engineering ↓ Technical Material Sourcing ↓ Process Engineering ↓ Draft Master Manufacturing Record (MMR) ↓ Quality Unit Approval ↓ Pilot Batch Execution (Production) ↓ Validation Support & Process Optimization ↓ Commercial Manufacturing

PETS Functional Responsibilities

Capability Purpose
Technical Feasibility Governance Maintain the facility capability model and technical rules used by Sales and AI-assisted tools to evaluate whether proposed products are manufacturable within established equipment and process limits.
Bench Process Development Perform manufacturability assessments and bench trials to evaluate how formulations behave under controlled process conditions and identify early manufacturing risks.
Formulation Scale-Up Engineering Adapt product formulations to ensure they perform reliably in manufacturing equipment and processes without altering product intent or product specifications.
Technical Material Sourcing Define ingredient specifications, acceptable supplier characteristics, and material attributes required for reliable manufacturing performance.
Process Engineering Design and optimize manufacturing processes including equipment settings, process parameters, control strategies, and technical troubleshooting to ensure consistent and scalable manufacturing performance.
MMR Engineering Translate the engineered process into a Draft Master Manufacturing Record that defines how the product will be manufactured.
Validation Engineering Support Support process validation and lifecycle monitoring by interpreting validation data, assisting with validation protocols, and recommending engineering improvements.

Functional Boundaries

Function Primary Responsibility
Product Development Product concept, ingredient selection, formulation design, and scientific development.
PETS Manufacturing engineering, process design, material technical specifications, and creation of draft manufacturing instructions.
Quality Unit Independent approval of Master Manufacturing Records, validation governance, material disposition, and overall compliance oversight.
Production Execution of pilot batches and commercial manufacturing according to approved instructions.
Procurement Commercial supplier negotiation, purchasing, and supply management.

Pilot Execution Model

For operational efficiency in a small manufacturing environment, pilot batches are executed by Production using existing production equipment and trained operators under controlled batch documentation.

PETS defines the pilot protocol and technical objectives, while the Quality Unit ensures compliance with documentation requirements and data integrity expectations.

Activity Owner
Pilot protocol design PETS
Pilot batch execution Production
Compliance oversight Quality Unit
Technical interpretation of results PETS

Material Governance Model

Because formulation attributes directly affect manufacturing performance, technical material selection remains under PETS authority.

Responsibility Owner
Ingredient technical specification PETS
Acceptable supplier definition PETS
Supplier negotiation Procurement
Purchase order execution Procurement

Governance Rules

Materials defined in an approved Master Manufacturing Record may not be substituted without formal change control review and Quality Unit approval.
Changes to materials, process parameters, equipment configurations, or manufacturing instructions defined in an approved Master Manufacturing Record require formal change control and Quality Unit approval prior to implementation.

Technical Authority

PETS serves as the technical authority for manufacturing process design, process parameters, and engineering interpretation of manufacturing data.

The Quality Unit retains independent authority for approval of controlled documentation, change control decisions, validation governance, and product disposition.

Expected Outcomes

Conclusion

The PETS function provides the technical framework that translates product concepts into robust, compliant manufacturing processes. By clearly defining functional boundaries between Product Development, PETS, Production, Procurement, and the Quality Unit, the organization ensures that products can move efficiently from concept to commercial manufacturing while maintaining technical integrity and regulatory compliance.