Regulatory Consulting for GMP manufacturing facilities
GMPACT’s regulatory group includes experienced employees, both ex-FDA and ex-industry, who provide comprehensive assistance through the manufacturing timeline, from pre-submission of pharmaceutical NDA/ANDA and medical device 510(k), to Manufacturing, Packaging and Testing.
Regulatory Affairs
THE EXPERTISE YOU NEED
The GMPACT goal is to provide manufacturing quality teams support for regulatory issues so that our clients can maintain good manufacturing practices (GMP) while gaining efficiency in manufacturing. GMPACT uses a multidisciplinary team of regulatory professionals and scientists to accomplish that goal; a team that can assist the quality unit while solving and answering technical problems in manufacturing, laboratory and packaging.
GMPACT offers assistance through FDA compliance audits or through larger scope FDA 483 remediation activities. The GMPACT team has assisted manufacturers through FDA responses by providing audits, data review, writing investigations, mentoring on investigations, performing root cause analysis, gap assessments of Standard Operation Procedures (SOP) and Standard Test Procedures (STP) and validation packages; and reviewing laboratory, manufacturing, and microbiological quality control and quality assurance systems.
GMPACT’s team has developed quality systems from the ground up, beginning in early phase clinical trials and managed those systems until full transition to site personnel has taken place. Additionally, the team has created and developed validation programs for equipment and processes. GMPACT personnel have served interim roles for companies to include: VP of Quality, Executive Safety Committee, Safety Management Team and on promotional material review boards.
capabilities
OUR SERVICES
Pre-Approval Phase
- Evaluation of applications (NDA/ANDA, PMA, 510(k))
- cGMP and Regulatory Training
- Pre-Approval Inspection and FDA Readiness
- Pilot to Full Scale Assessment Plans
- Clinical Trial Material Manufacturing and Testing
- Clinical Trial Quality Assurance
- Unblinded Clinical Trial Management
- SOP/STP Development, Creation and Gap Assessment
- Validation Development, Creation and Gap Assessment
- Data Integrity Evaluations
- Vendor Qualifications
- OOS/OOT Specifications
cGMP Quality Manufacturing
- Perform Quality System Assessments
- FDA Compliance Improvement Strategies
- REGULATORY AND COMPLIANCE EXPERTISE
- FDA Preparation and Readiness
- Conduct Mock cGMP and Pre-Approval Audits
- International and Domestic Manufacturers
- Remediation Recommendations
- Technical Assessments of cGMP Operations
- SOP and STP Gap Assessments
- Comprehensive cGMP System Inspections and Corrective Action Plans
- Quality Assurance, Quality Control, Validation and cGMP support
- Validation Protocol Development and Execution
- Cleaning Validations (assessment, design, and/or execution)
- Materials Supply Chain Management Systems
FDA 483 Observations/Warning Letters
- Response Strategies
- Corrective Action Plans
- Training
- Liaison to FDA Field and Headquarters Offices
- Retrospective Review of Quality Records and Investigations
- Batch Record Review and Release
- Laboratory Data Review and Release
Post Marketing
- Complaint Handling and Pharmacovigilance Activities
- Safety Management
- Labeling and Promotional Review
Regulatory Training Programs
- FDA Regulatory Expectations
- Good Documentation Practices
- Complaint Handling
- Data Integrity
- GMP 101
- Investigations and Root Cause Analysis
- Risk Management
- GMP Quality Management Systems
- Change Control
- Inspection Readiness
Pharmaceutical Manufacturing Deviation Investigations
GMPACT has performed thousands of deviation investigations to determine root cause and assist the pharmaceutical quality team in decisions regarding product disposition. These investigations have included all phases of the product material chain: raw materials, bulk blend finished product attributes, expanded AQL testing, packaging and complaints. GMPACT has been able to obtain true root causes and corrective actions to present ongoing occurrences.
SOP and STP Gap Analysis
GMPACT has reviewed thousands of SOP/STP for accuracy of instruction, clarity, and capture of critical process parameters. By utilizing a team of regulatory professionals, GMPACT has been able to close gaps in SOP/STPs and provide guidance as it relates to regulatory expectation. GMPACT has performed this work as a part of investigation corrective actions, and as a part of site wide initiatives to improve SOP’s. GMPACT has also developed and created full commercial quality systems and clinical SOPs.
About Us
Meet the Team
Jennifer Ahearn
Owner/CEO
Ms. Jennifer Ahearn specializes in FDA regulated product compliance. She has served numerous roles within the FDA including bench chemist, domestic and international investigator, technical liaison for FDA’s Office of Criminal Investigations, and member of FDA’s National Training Cadre making her an expert in the interpretation and application of cGMP regulations relating to FDA regulated product quality and manufacturing.
Read full bioMs. Ahearn has assisted pharmaceutical, medical device and dietary supplement companies preparing for FDA inspections, as well as responding to FDA 483 observations after an inspection. She has worked to resolve technical and FDA compliance issues for virtually all pharmaceutical dosage forms, OTC products, medical devices, combination products and dietary supplements.
Daniel Spankie
President
Mr. Daniel Spankie specializes in pharmaceutical and medical device regulatory compliance in the fields of quality control, chemistry, regulatory compliance, analytical method development, data integrity, and validation. He has successfully managed large quality organizations through warning letter and site remediation projects.
Read full bioIn his role as Informatics Specialist, he helped design and implement Chromatography Data Systems (CDS), Scientific Data Management Systems (SDMS), and Laboratory Information Management Systems (LIMS) for both site based and global cGxP networks. He has extensive background in auditing and remediation of data integrity issues and has developed certification programs for data reviewers in regulated environments. Mr. Spankie focuses on providing compliant, robust, and efficient solutions and processes for validation programs, laboratory and manufacturing.