Quality Assurance & GMP Services
Ensuring Excellence from concept stage to marketing stage
Quality Assurance Consultants – Interim Management, staff augmentation, or outsourcing quality and regulatory management has become increasingly common in the life science industry. The quality assurance (QA) and regulatory affairs (RA) functions create extra complexity for large and small life science companies. Quality assurance and testing needs may vary greatly depending on the organization’s lifecycle, and MONOGRAPHA PHARMA quality consultants are up to the task.
QA Audit – Virtual gap assessments can assist your team in advance for an upcoming QA inspection by a notified body. These proactive organizations turn to MONOGRAPH PHARMA for quality assurance consultant Experts who can describe the highest quality standards a notified body will look for.
Our areas of expertise include identifying and assessing any deficiencies to help determine the best approach and compliance assessment solutions. We can perform a “deep dive” into any quality system or process that you feel needs a good top-to-bottom assessment.
our Compliance Assurance Assessment services for the pharmaceutical industry include:
- Current Good Manufacturing Practice (cGMP)
- International Organization for Standardization (ISO)
- Quality Infrastructure
- Any Time Audit Readiness
- Corrective and preventive Action (CAPA)
- Validation
- Facility and Maintenance
- Pre-Approval Inspection (PAI)
- Data Integrity
- Start-up Assessments
Compliance and Audit Services
Audit readiness
We meticulously prepare your team and processes for Regulatory audits, ensuring no compliance stone is left unturned.
Mock audit
Our mock audits expose potential weaknesses, providing the insights needed to fortify your practices.
Gap analysis & assessment for SOPs
We evaluate your SOPs to uncover gaps, aligning them with the latest Regulatory requirements.
Regulatory training
We offer comprehensive training sessions to update your staff on the newest regulations and compliance techniques.
Document management
Our experts help you develop and maintain a robust documentation system that meets Regulatory standards.
Risk management
We identify and mitigate risks associated with Regulatory non-compliance, safeguarding your business operations.
Continuous improvement
Our continuous improvement strategies ensure your compliance processes evolve in line with changing regulations.
Vendor Evaluation | Vendor Audit | Mock Audit | Target Audit | Regulatory Audit Findings Closure |
Audit and Closure Evaluation of multiple potential vendors for Third-Party service or product | Perform Audit | Audit readiness mentoring | Auditing an area/ process, which is troublesome for the customer | Designing CAPA for a Regulatory Audit/Customer Audit finding Evaluating the efficiency of CAPA |
Audit and Report
GMP vendor audits
Vendor performance assessment Compliance audit performance
Gap analysis checklist
Compliance audit report submission
Compliance assessment
Audit and Closure
Compliance audit performance
Compliance audit report preparation/submission
Recommendations on closures
Problem resolution
Follow-up audit performance