Conducting Pilot Batch Manufacturing in Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting pilot batch manufacturing during the formulation development process, aiming to validate the manufacturing process and produce batches for initial stability and performance evaluation.

2) Scope

This SOP applies to all formulation development projects within the organization, covering pilot batch manufacturing activities from initial planning to final batch evaluation and documentation.

3) Responsibilities

The responsibilities for this SOP include:
Project Manager: Overseeing pilot batch manufacturing activities and ensuring compliance with project objectives, timelines, and budget.
Production Team: Executing pilot batch manufacturing according to defined procedures and safety guidelines.
Quality Assurance: Reviewing and approving pilot batch manufacturing protocols, batch records, and final product quality.

4) Procedure

4.1 Pilot Batch Planning

1. Review formulation and process development data to finalize batch size and manufacturing parameters.
2. Define objectives for pilot batch manufacturing, including process validation and initial product evaluation.
3. Develop a pilot batch manufacturing plan outlining critical process parameters (CPPs) and validation requirements.
4. Document the pilot batch plan and obtain approval from stakeholders.

4.2 Equipment and Facility Preparation

1. Prepare manufacturing equipment and facilities to meet pilot batch requirements (e.g., cleaning, calibration).
2. Verify availability and readiness of raw materials, components, and utilities.
3. Ensure compliance with Good Manufacturing Practices (GMP) and safety protocols.

4.3 Pilot Batch Manufacturing

1. Follow approved batch records and standard operating procedures (SOPs) to manufacture pilot batches.
2. Monitor and control CPPs throughout the manufacturing process to ensure batch uniformity and product quality.
3. Document all manufacturing activities, including deviations and corrective actions taken.

4.4 In-Process Testing and Quality Control

1. Perform in-process testing and sampling according to approved protocols and specifications.
2. Evaluate batch samples for critical quality attributes (CQAs) and document test results.
3. Initiate investigations and corrective actions for any out-of-specification (OOS) results.

4.5 Batch Documentation and Release

1. Complete batch documentation, including batch production records, in-process test results, and deviations.
2. Submit batch documentation for review and approval by quality assurance.
3. Release approved pilot batches for stability testing and further evaluation.

4.6 Post-Manufacturing Activities

1. Review manufacturing data and performance metrics to identify process improvements and optimization opportunities.
2. Prepare summary reports on pilot batch manufacturing outcomes, including recommendations for scale-up.
3. Archive all batch records and related documentation in compliance with regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
CQAs: Critical Quality Attributes
GMP: Good Manufacturing Practices
OOS: Out-of-Specification

6) Documents, if any

Pilot Batch Manufacturing Plan
Batch Production Records
In-Process Test Results
Deviation Reports
Batch Release Documentation

7) Reference, if any

– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
– FDA Guidance for Industry: Process Validation: General Principles and Practices

8) SOP Version

Version 1.0