Phama Biotech Services
REMEDIATION OF ENFORCEMENT ACTIONS
QualiCulture support the pharma biotech companies in responding to inspectional observations and enforcement actions. Our team includes experts with decades of experience helping companies develop strategic plans to address enforcement actions (FDA, MHRA, Health Canada, TGA etc.). Our experts have a proven track record for addressing the most complex regulatory problems and compliance issues. We can help companies in providing the comprehensive and holistic responses which provides necessary coverage to the applicable regulations, CAPA (issue specific and global) and impact on quality of the products in relation to FDA 483 Inspectional Observations, warning letters, critical findings from European authorities, and import alerts.
Our experts have a proven track record for addressing the most complex regulatory problems and compliance issues.
In order accomplish this our experts develop strategic plans to address enforcement actions (FDA, MHRA, Health Canada, etc.) such as FDA Form 483, Warning Letter, Critical EU Agency Findings, Data integrity, Import Alert and more. We develop solutions collaboratively with companies to achieve a practically compliant quality system to prevent future occurrences of similar compliance deficiencies. It includes.
- Evaluation of observation
- Correction of the issue – Issue specific and Systemic / Global Corrections
- Impact Assessment :
- Containment Actions and Field action determination;
- Immediate and Interim actions to eliminate immediate potential risk
- Extension of the scope if applicable to other processes, products and sites
- Effectiveness Check plan and Execution
REGULATORY MEETING/INTERACTIONS:
We provide assistance to clients for meeting interactions with regulatory agency. It includes- Evaluation of Remedial Actions and Preparing briefing documents (Presentations)
- Organizing meeting preparation sessions
REMEDIATION OF QUALITY SYSTEMS
Strong and robust quality systems are required for companies to produce safe, high-quality products consistently and reliably. Not addressing concerns highlighted in FDA 483s and FDA warning letters in an effective manner may result in regulatory enforcement actions such as pause in manufacturing, recall, import bans, detention or product seizure.
To stay current regulatory authorities releases guidance for industry. In this area, QualiCulture provides expertise services in creating, implementing, reviewing and remediating quality systems.
To accomplish this the following schema shall be followed by QualiCulture SMEs.
The above schema covers the following elements in the pharmaceutical quality management system:
ONSITE REMEDIATION:
- Quality system
- Laboratory controls
- Material controls
- Facilities and equipment
- Production system
- Packaging and Labeling
AUDITING
QualiCulture performs comprehensive audits to verify the client quality systems / current operations compliance to 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 clients 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 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 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 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 plan for high risk issues (if any).
Our experts partner with client 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 one to one interview of SMEs on High-risk issues with elemental review. We not only interview the SMEs and advise SME 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 the strategic planning to manage the regulatory inspections in best way. It includes:
TRAINING:
Focused training on Inspection Readiness, It includes- Inspection Plan and Communication
- Do’s and Don’ts during inspection
- All Time inspection Readiness
KEY DOCUMENT READINESS:
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- Review of Site master file (SMF) and Validation Master Plan (VMP)
- Review of Product Documentation that are 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:
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- Review of previous regulatory issues and its 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
TRAINING AND CAPABILITY BUILDING
We offer comprehensive training programs designed to develop the knowledge and skills needed to perform day to data activities complying to meet the challenges of a global and complex pharmaceutical industry. Our programs are frequently global in scope and may be tailored to a local language and culture along with knowledge assessment.
Our key trainings include:
- Pharmaceutical Regulations – An Introduction
- Current Good Manufacturing Practices (cGMP – ICHQ7)
- Good Documentation practices
- Aseptic processing / Sterility Assurance
- Environmental Monitoring
- Quality Culture – Data Integrity
- Cleaning, Sanitization and Disinfection
- Sterilization Processes
- Interventions Execution and Clean room Behaviour
- Inspection readiness
- Performing Effective Investigations (Deviations, OOS and Market Complaints)
- Good Documentation Review Practices – Batch Manufacturing Records and Analytical Test Records
These training courses concentrate on an overview over the comprehensive national and international regulations, relevant GMP guidance and case studies.
QualiCulture also assists the firms in capability building through specialized protocol-based exercises. The key capability Building Programs include:
- Investigators Qualification
- Internal Auditors Qualification
- Aseptic Operators Practices and Techniques Qualification
By answering these questions we facilitate applying GMP on a day-to-day basis, promote understanding of GMP regulations and foster a positive attitude towards GMP.
The workshops and group discussions on current issues also makes the trainees become aware of GMP regulations and solves actual problems.
Our onsite trainings differentiate Basic and Special Trainings. While Basic Trainings provide fundamentals, Special Trainings help to advance knowledge or to gain knowledge in one specific area.
REGULATORY APPLICATIONS REVIEW SUPPORT
QualiCulture offers expert regulatory support and consulting services to all sizes of pharmaceutical and biotech companies to interpret or navigate the intricacies of pharmaceutical and biotechnology regulations.
We provide regulatory strategies, based on your corporate objectives, for product development, FDA approval pathways or lifecycle management of marketed pharmaceuticals and biologics.
We also support review of regulatory documentation. It includes the protocol-based review and assessment of regulatory applications (DMF / NDA /ANDA) for their accuracy and completeness. We provide expert services that evaluate the potential effects of data inaccuracies on submitted applications (Approved and Pending for Approval) with regulatory agencies.
ASSESSMENT OF LABORATORY CONTROLS
We offer protocol based assessment of laboratory controls established at pharmaceuticaland biotech manufacturing firms.
It includes in-depth onsite review and assessment of quality control testing performed bylaboratory to uncover the gaps which can compromise the accuracy and completeness of the analyticaldata. It also includes the evaluation of analytical methods for adequacy andsuggestions for improvements.
We also support the pharma and biotech companies inthe development of corrective and preventive action plan for the identifiedgaps along with product impact assessment.
- Review and assessmentof Analytical data (chromatographic and non-chromatographic analysis) for accuracy and completeness
- Review and Assessment of Controls exercised over computerizedsystems used in quality controls laboratories
- Comprehensive assessment of laboratory practices
- Quality Control test Samples handling and Management
- Analytical Method Validation
- Analytical Instrument Qualification
- Test Methods and Procedures
- Analytical data management (Hard copy and Electronic Data)
- Reporting and Documentation of Results
QualiCulture provides following expert services in the area of Microbiology and Sterility Assurance.
MICROBIOLOGY:
- Systemic evaluation of Microbiology laboratory
- Review of practices for adequacy and appropriateness
- Collaboration with client in investigation of repeat environmental monitoring failures, water failures and products failures
STERILITY ASSURANCE:
- Creation of best aseptic processing procedures / Clean room disciplines
- Risk assessments (Sterile Product Compliance Risk Assessment) to determine the enhancements in legacy aseptic manufacturing facilities
- Material transfer to cleanareas
- Aseptic intervention execution
- Management and revisiting ofinterventions to establish robust media fill design
- Comprehensive AsepticProcessing Risk Assessment – Materials, Practices, Procedures, Design, Products attributes
- Trainings – Clean room Behaviour, Environmental Monitoring program, Gowning practices, Cleaning andDisinfection, Sterilization etc.
- Aseptic Process Simulation (Media Fill) designand oversight
- Media Fill Failureinvestigations