Operational Quality

  • ✅ Operational Quality services ensure that every aspect of your production meets stringent quality and regulatory standards. Our specialized services include:
  • ✅ Auditing Services: Comprehensive audits to assess your manufacturing processes and compliance with internal or industry standards. For more information, see our Auditing Services page.
  • ✅ Regulatory Inspection Readiness: Preparing your organization Operational Quality, Commercial Quality or CMOs  for regulatory and client audits through structured gap analyses and internal audits to ensure you are fully compliant and ready for audits.
  • ✅ SOP Preparation and Implementation: Creation and implementation of Standard Operating Procedures (SOPs) to standardize and optimize manufacturing processes (Operational Quality). We also provide services to update existing SOPs as part of continuous improvement through gap analysis against your provided quality standards.
  • ✅ Gap Analysis: Conducting gap analyses of quality systems against industry standards, contractual agreements with any clients, and ISO standards such as ISO 9001 and ISO 22000 integrated with HACCP.
  • ✅ Management of Suppliers and Contractors: Assisting your suppliers and contractors in meeting your contractual quality standards and regulatory requirements by providing end-to-end services. To know more details, see our pages on Third-Party Services / CMOs and Supplier Quality Services.
  • ✅ ISO Certification: Assisting your organization or third-party contractors/CMOs in achieving certification for quality (ISO 9001) and food safety management systems (ISO 22000 integrated with HACCP). For more details, see our relevant pages.
  • ✅ HACCP Implementation: Development and implementation of Hazard Analysis and Critical Control Points (HACCP) systems to ensure food safety.
  • ✅ Risk Management: Identification and mitigation of risks associated with manufacturing processes.
  • ✅ Deviation Management: Systems to manage and investigate deviations from established processes or specifications.
  • ✅ Change Control Management: Processes to manage changes in manufacturing procedures, equipment, or materials to ensure continued compliance.
  • ✅ Product Stability: Monitoring and managing the stability of products throughout their lifecycle.
  • ✅ PQR/APQR: Conducting Periodic Quality Reviews (PQR) and Annual Product Quality Reviews (APQR) to evaluate and ensure ongoing product quality.
  • ✅ Training: Customized training programs to enhance your team’s skills and ensure adherence to quality standards. See our Training page for more details.
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Specialities

Operational Quality

Operational Quality services ensure that every aspect of your production meets stringent quality and regulatory standards. Our specialized services include:

  • Comprehensive audits to assess your manufacturing processes and compliance with internal or industry standards. For more information, see our Auditing Services page.

Preparing your organization Operational Quality, Commercial Quality or CMOs  for regulatory and client audits through structured gap analyses and internal audits to ensure you are fully compliant and ready for audits.

  • Creation and implementation of Standard Operating Procedures (SOPs) to standardize and optimize manufacturing processes (Operational Quality). We also provide services to update existing SOPs as part of continuous improvement through gap analysis against your provided quality standards.
  • Conducting gap analyses of quality systems against industry standards, contractual agreements with any clients, and ISO standards such as ISO 9001 and ISO 22000 integrated with HACCP.

Assisting your suppliers and contractors in meeting your contractual quality standards and regulatory requirements by providing end-to-end services. To know more details, see our pages on Third-Party Services / CMOs and Supplier Quality Services.

Assisting your organization or third-party contractors/CMOs in achieving certification for quality (ISO 9001) and food safety management systems (ISO 22000 integrated with HACCP). For more details, see our relevant pages.

Development and implementation of Hazard Analysis and Critical Control Points (HACCP) systems to ensure food safety.

Identification and mitigation of risks associated with manufacturing processes.

Systems to manage and investigate deviations from established processes or specifications.

Processes to manage changes in manufacturing procedures, equipment, or materials to ensure continued compliance.

Monitoring and managing the stability of products throughout their lifecycle.

Conducting Periodic Quality Reviews (PQR) and Annual Product Quality Reviews (APQR) to evaluate and ensure ongoing product quality.

Customized training programs to enhance your team’s skills and ensure adherence to quality standards. See our Training page for more details.