Documentation (Site Master File - SMF)

 

1. Site Selection and Facility Design: Assistance with choosing an appropriate location and designing the facility layout (including cleanroom design and HVAC systems) to prevent cross-contamination and ensure efficient workflow, in compliance with regulatory standards.

 

2. GMP/GCP Compliance Guidance: Expert guidance on adhering to global regulatory standards (e.g., EU GMP Annex 13 for Investigational Medicinal Products), ensuring that all operations, from raw material handling to product distribution, meet quality and safety requirements.

 

3. Documentation and SOP Development: Preparation, revision, and

distribution of all necessary documentation, including

Standard Operating Procedures (SOPs), batch manufacturing records,

and the entire Site Master File (SMF).

 

4. Validation and Qualification: Development and

execution of validation master plans, including

Installation Qualification (IQ), Operational Qualification (OQ),

and Performance Qualification (PQ) for equipment, processes,

and computerized systems.

 

5. Quality Management System (QMS) Implementation: Description and implementation of a robust quality assurance system, including procedures for handling deviations, investigations, corrective and preventive actions (CAPA), and internal audits.

 

6. Regulatory Submissions and Audits: Support in preparing regulatory submissions (e.g., Common Technical Document - CTD, Drug Master Files - DMF), responding to deficiency letters, and conducting mock audits to prepare for official inspections.

 

7. Risk Assessment and Mitigation: Identification and evaluation of potential risks related to product quality and process performance, with strategies for mitigation to ensure a state of control.