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PETS – Process Engineering & TechOps Services

The Process Engineering & TechOps Services (PETS) business process defines how manufacturing processes, formulations, and technical standards are designed, specified, controlled, validated, and continuously improved to ensure robust, compliant, and repeatable GMP manufacturing operations.

Technical Governance Context

Executed by Technical Operations • Governed by the Quality Management System (QMS) • Independently overseen by Quality Assurance (QA)

PETS Operating Model

The PETS Operating Model illustrates how process knowledge is translated into controlled technical documentation and transferred to Manufacturing for compliant execution under approved instructions.

PETS Inputs
Product Development data and transfer packages
Process validation and development studies
Regulatory and compliance requirements
Deviation investigations and trend data
Continuous improvement initiatives
Process Design & Technical Control Flow
Process & Formulation Design
Development of manufacturing process flow, formulation composition, and technical operating strategy
Specification & Parameter Definition
Establishment of formulation standards, material specifications, critical process parameters (CPPs), and in-process control (IPC) expectations
MMR Authoring & Lifecycle Control
Drafting, revising, and maintaining controlled Master Manufacturing Records under formal document control
Technical Oversight & Optimization
Process troubleshooting, deviation technical assessment, validation support, and continuous improvement implementation
Controlled Technical Transfer to Production
PETS Outputs
Approved Master Manufacturing Records (MMRs)
Defined CPPs and IPC acceptance criteria
Controlled formulation and material specifications
Technical risk assessments and improvement plans

PETS establishes the technical framework for manufacturing execution. Production begins only after issuance of QA-approved manufacturing instructions and release of materials through the appropriate upstream processes.

Process Interfaces & Boundaries

  • Upstream: Product Development (PD) – technical knowledge and process transfer
  • Downstream: Production (PROD) – execution of approved Master Manufacturing Records
  • Quality Interface: QA – document approval, change control, and validation oversight
  • Governance: QMS defines document control, change management, validation, and data integrity requirements

Authority & Functional Boundaries

PETS is classified as a Process-Designing and Technical-Governance Domain. PETS defines and maintains the technical standards for manufacturing but does not execute GMP production activities or control material disposition.

  • PETS defines formulations, technical specifications, and manufacturing strategies.
  • PETS establishes critical process parameters (CPPs) and in-process control (IPC) criteria.
  • PETS authors and maintains Master Manufacturing Records under document control.
  • PETS provides technical assessment during deviations and supports root cause analysis.
  • PETS supports validation and process performance monitoring.
  • PETS does not release raw materials, intermediates, or finished goods.
  • PETS does not issue materials to Production.
  • PETS does not execute manufacturing batches.
  • PETS does not independently determine final product disposition.

All changes to formulations, specifications, process parameters, or validated operating ranges are managed through formal Change Control in accordance with the Quality Management System. Material process changes require documented impact assessment, risk evaluation, validation review, and QA approval prior to implementation.