GMP Consulting Services
Good manufacturing practice (GMP) compliance is essential for any organization that manufactures, processes, packs, or stores pharmaceutical products. EQC offers GMP consulting services and comprehensive support to help ensure compliance with cGMP regulations.
Our services are tailored to meet the specific needs of your organization and can be delivered on-site or remotely. We also offer a range of courses and webinars that help you stay updated on the latest GMP developments. With EQC, you can be confident that your operations are in compliance with the latest cGMP requirements.
Vendor Qualification
- Development of vendor qualification program
- Identification of primary, secondary, and tertiary vendors
- Initial on-site and virtual audits of GMP manufacturers, testing labs, storage, and distribution, product labeling, and packaging
- For-cause audits due to poor vendor performance
- Annual/biannual audits
- Detailed audit reports supporting a selection of vendors
- Issuance of audit observations to vendors and follow-up on correct actions
Quality Assurance Management & Execution
- QA leadership in day-to-day GxP activities
- Production deviation reviews to ensure compliance and thoroughness
- Conduct internal audits and assistance with remediation
- Quality Systems gap assessments
- Authoring of new and revised Quality Systems procedures
- Review of equipment calibration certificates and qualification reports
- Review of analytical method validation protocols and reports
GxP Training
- Development of client-specific GxP training programs
- New employee and annual GxP training programs
- Practical application of U.S and E.U Regulations
- Cleanroom controls and routine monitoring
- Data Integrity and 21 CFR Part 11
- Pre-approval inspections
Data Integrity Gap Assessment & Remediation
- Detailed gap assessments of client’s paper, hybrid, and electronic systems for compliance with regulations
- Authoring of data integrity remediation plans
- Collaboration with the client to create a practical timeline for remediation
- On-site or virtual assistance with the implementation of remediation
- Coordination with client-approved vendors to ensure completion of remediation actions
Remediation of Regulatory Observations
- Review and assessment of regulatory findings
- Collaborate with sponsor subject matter experts to understand history of issues
- Development of short/long-term corrective/preventative action plan
- Revising/authoring new SOPs and forms to meet regulatory requirements
- Training of staff in new/revised SOPs
- Training of staff in the presentation of corrective actions to regulatory agencies
- Training of staff in hosting follow-up regulatory inspections
Design & Build Quality Systems
- Quality manual/policy
- Quality systems training
- Deviations and out-of-specification investigations
- Corrective/preventative actions
- Document/equipment change control
- Calibration and validation program
- Facility commissioning
- Stability program
- Internal and external audits
Employee SOP Training Module
- Development of master training programs
- Development of SOP training modules for new and revised SOPs
- Creation of SOP quizzes and tests
- On-site and virtual training of employees in SOP
Reduce QA Work Backlogs
- Executed production batch records
- Assessment of production deviations and corrective actions
- Product release data
- Product shipment temperature excursions
- Stability reports for API and product
- Out of Specification investigations
- Laboratory deviations
- Equipment calibration certificates
- Equipment qualification/validation reports and data
- Facility calibration/validation
