Good Manufacturing Practice Services
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Beckloff Associates has developed successful relationships throughout the world. Our experience has enabled us to be sensitive to communication and cultural differences existing among countries. Our strategy is to increase the financial return on research investments for our clients by designing and implementing scientific regulatory strategies that decrease development time and increase market years for health care products.
- United States FDA and European Union Good Manufacturing Practice Audits
- Establishment Inspections ? Conduct first audit of the facility for assessment of six quality systems covering quality, facilities and equipment, materials, production, packaging and labeling, and laboratory controls systems.
- Directed Inspections ? Conduct audit directed to a specific product, product filing, process, investigation, or other directed activities using the applicable elements of the six quality-systems audit.
- Pre-Approval Inspection (PAI) Readiness ? Conduct audit in the manner that regulatory agencies will conduct the audit. The focus will be to ensure that the information provided in the regulatory filing is supported by the documentation at the facility and that the documentation is in compliance with current Good Manufacturing Practices (CGMP) and the firm?s quality system.
- Post-Approval Inspections ? Conduct audit with a focus on ensuring that the commercial product is still being manufactured and controlled per the requirements of the regulatory filing. Regulatory commitments such as periodic safety reports, complaint handling, and product returns will also be assessed.
- International Conference on Harmonisation (ICH) Q7 Audits ? Conduct audit specific to active pharmaceutical ingredients (API) to assure that the API is manufactured and controlled per the requirements of the ICH Q7 CGMP Guide for APIs.
- Excipient Supplier Audits ? Conduct audit using the guidance put forth by the International Pharmaceutical Excipients Council (IPEC), which is the worldwide leader in excipient quality systems covering CGMP regulations for excipients, certificate of analysis guidance, and significant change guidance.
- ISO13485 and FDA Quality System Regulation (QSR) Audits
- Audits conducted worldwide; experience in working/traveling in Canada, Mexico, Europe, Asia, and Latin America
- Auditors have diverse experience, including conduct of the following types of audits:
- Solid, liquid, cream, ointments, sterile injectable, ophthalmic, and transdermal dosage forms
- API expertise from gram scale to metric ton including synthetically produced, fermentation, biologic, and botanical APIs
- Previous membership as part of an IPEC company with extensive experience in the development and audit of a novel excipient, as well as extensive experience with excipient supplier audits
- Conduct of audits of dietary supplement manufacturers
- Batch Production and Packaging Record Audits ? Conduct in-office or on-site review of batch production and packaging record audits for compliance to the master production record and the regulatory filing commitments.
- Analytical Data Audits ? Conduct in-office or on-site review of analytical data for compliance to the written testing procedure, firm?s standard operating procedure (SOP), and CGMP compliance to assure that data supports the product quality and that product release decisions are based on not only CGMP compliance, but sound scientific principles.
- Process Validation Protocol Preparation and Review
- Facility Design Reviews
- U.S. FDA and Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) Audits ? Conduct audits to U.S. FDA, Part 58 GLP regulations and OECD GLP Guideline. Additionally, perform assessment of animal facilities for compliance to U.S. FDA, United States Department of Agriculture (USDA), and Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) standards.
- Study Protocol Audits ? Review study protocols to assure that the requisite information to meet FDA and OECD requirements have been met and ensure the study design is adequate from a compliance standpoint.
- Data and Report Audits ? Conduct in-office or on-site review of data and reports to ensure the study was conducted in compliance with the study protocol, analytical methods, SOPs, and overall GLP requirements.
- Bioanalytical Method, Data, and Report Audits ? Conduct in-office or on-site review of data and reports to assure the study was conducted in compliance with the study protocol, analytical methods, SOPs, the FDA Guide to Bioanalytical Method Validation, and overall GLP requirements.
- ICH E6 Clinical Investigator Site Audits ? Conduct audits of clinical/investigational pharmacies and clinical units to evaluate investigator qualification/capabilities, protocol compliance, Good Clinical Practice (GCP) compliance, patient consent, source data verification, clinical study processes, data quality, facilities, adverse event reporting, and control and disposition of investigational product.
- Vendor Audits ? Conduct general capabilities and compliance assessments of Contract Research Organizations (CRO), clinical laboratories, clinical supplies manufacturing and distribution vendors, and medical service providers.
- Due Diligence Audits ? Evaluate key safety and efficacy variables, data accuracy/integrity, data authentication, patient authentication, and conduct for cause audits.
- Quality Systems Audits ? Assessment and evaluation of organization, operations, quality assurance unit, employee training, vendor selection and management, manufacturing controls, clinical trial management, regulatory compliance, drug safety, and safety reporting.
- Pre-FDA Inspection Readiness Audits ? Assessment, preparation, and training for FDA inspections of clinical investigator sites and contract service providers.
- 21 CFR, Part 11 Compliance Audits ? Perform expert assessment of electronic records and electronic signature compliance to the FDA regulation.
- Standard Operating Procedure (SOP) Preparation and Review ? Prepare SOPs for seamless implementation and execution. Extensive experience in preparing SOPs to support quality, laboratory, manufacturing, and computer validation areas.
- Installation, Operation, and Performance Qualification (IQ, OQ, PQ) Protocol Preparation and Review ? Prepare and review IQ, OQ, and PQ protocols to support equipment and computer validation activities
- Validation Master Plan Preparation and Review ? Prepare and review validation master plans to support facilities, equipment, process, analytical methods, and computer validation.
- Preparation and Review of Sterilization Submission Document ? Prepare the Common Technical Document (CTD) Section 3.2.P.3.5 or traditional format of the sterilization validation information to support sterile products per the FDA Guide to the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products, November 1994.
- Analytical Method Development and Validation Review ? Review analytical method development and method validation protocols to assure compliance to the requirements of ICH Q2A and USP <1225>.
- Quality Assurance and Due Diligence Reviews of Regulatory Documents in CTD Format ? Perform assessment of regulatory filings in CTD format to assure the format is compliant and the requirements for U.S. INDs, NDAs, and ANDAs, European IMPDs and MAAs, and Canadian CTAs are met.
- Annual Product Quality Reviews ? Review and prepare annual product quality reviews for API and drug products.
- Ability to serve as a remote quality unit
- Data audits can be conducted at Beckloff offices via File Transfer Protocol (FTP) links or overnight mailings of data sets, allowing for flexibility and cost savings versus on-site visits.
- Compliance Audit Remediation Support
- Preparation of Quality Agreements
- On-site Compliance Training Programs
- Conduct a Regulatory and Compliance Workshop at the Beckloff Overland Park, Kansas office (presented annually or semiannually based on number of participants).