Qualiculture

Phama Biotech Services

AUDITING

QualiCulture performs comprehensive audits to verify the client quality systems / current operations compliance with the latest GMP regulations and expectations. We work with them in the development, implementation, and verification of corrective and preventive action plans (CAPAs) that are comprehensive, compliant, and sustainable.

We assess the client operations against all major international regulatory and GMP standards, including EU, USA, Canada, Australia, WHO, and more.  

We perform various types of audits to evaluate the client’s operations. It includes: QUALITY SYSTEM AUDITS, DATA INTEGRITY AUDITS, COMPLIANCE, AND THIRD-PARTY AUDITS.

We perform a thorough, in-depth (forensic) assessment of QMS against the latest regulatory requirements and industry best practices.

Focused assessment of the following:

Aseptic manufacturing operations and Microbiology Techniques
Review of all aspects of records and data recording practices including laboratory systems and electronic storage
Data integrity assessments through the forensic way of auditing
Investigations and CAPA effectiveness checks

We identify fragile systems and areas for improvement and recommend solutions to address deficiencies. We provide a detailed audit report to develop a corrective action plan (CAPA) to remediate deficiencies and create a more robust and sustainable QMS.

INSPECTION READINESS:

We perform inspection readiness evaluation of companies through the following.

MOCK INSPECTIONS:

We determine audit readiness by testing clients’ knowledge of procedures and by creating a process that simulates the pressure of an actual inspection. As part of Mock inspections, we perform an in-depth, expert assessment of a specific technical issue and quality system, it also includes the creation of interim and long-term action plans for high-risk issues (if any).  

Our experts partner with clients in the development, implementation, and verification of corrective action plans (CAPAs) that are comprehensive, compliant, and sustainable. We also determine the interim and long-term action plans through quality risk assessment.

SME READINESS:

We perform an evaluation of SME readiness on presentation to inspectors through interviews. It includes a one-to-one interview of SMEs on High-risk issues with the elemental review. We not only interview the SMEs and advise SMEs on the best way to answer questions and present data to build capability and confidence, which in turn helps for better preparation for the real thing.  

STRATEGIC PLANNING:

We provide strategic planning to manage the regulatory inspections in the best way. It includes:

TRAINING:

Focused training on Inspection Readiness, It includes

Inspection Plan and Communication
Do’s and Don’ts during the inspection
All Time inspection Readiness

KEY DOCUMENT READINESS:

Review of Site master file (SMF) and Validation Master Plan (VMP)
Review of Product Documentation that is under the scope
Quality management systems: deviation and CAPA, complaints, OOS, documentation systems
Review of facility and utility design, validation, and operation
Review of validation plans and completed studies
Regulatory compliance for computers and automated control systems
Review and evaluation of microbiological tests and aseptic practices by witnessing the operation

PROOF BOOK VERIFICATION:

Review of previous regulatory issues and their responses for adequacy and compliance
Commitment / CAPA Vs Procedure Vs Practice
Creation of CAPA plan based on prevailing regulations for the identified gaps along with product quality impact assessment