PHARMA – BIOTECH – OTC

Preparation for FDA Regulatory Inspection (21 CFR 210/211)

BEC has provided FDA inspection readiness services for the last twelve years with an excellent success rate. Our expert service includes the following activities:

• Initial gap assessment to identify opportunity areas, including comprehensive data integrity assessment
• Development of a detailed and comprehensive remediation plan to address weak or non-compliance areas
• Training your staff to prepare for an FDA inspection and how to interact with the inspector
• Formal mock inspection to practice and to challenge staff and quality systems prior to the inspection
• War-room handling/support during the inspection, with both onsite and remote expert support
• Post-inspection support preparing formal responses and managing interactions with the FDA, including regulatory meeting preparation and support

We have extensive experience helping companies to address critical agency findings, as well as untitled and warning letters. We have a proven, demonstrable track record addressing complex regulatory problems and compliance issues.

Preparation for FDA Pre-Approval Inspection (PAI)

The inspection focus and methodologies used by FDA inspectors during pre-approval inspections (PAI) are different to those used for regular, surveillance, postmarket inspections. Before approval, the FDA typically evaluates the manufacturer by on-site inspections when the company is named in the Chemistry, Manufacturing, and Controls (CMC) section of a New Drug Application (NDA), Abbreviated New Drug Application (ANDA) or Biologic License Application (BLA). The pre-approval inspection (PAI) is performed to contribute to the FDA’s assurance that a manufacturing establishment named in a drug application is capable of manufacturing a drug, and that submitted data is accurate and complete.

Our company has extensive experience helping companies with NDA and ANDA pre-approval inspections. In this case, in addition to all preparation activities mentioned for regular FDA inspections, our experts will perform an intensive assessment of the following three elements:

• Readiness for Commercial Manufacturing
• Conformance to Application
• Data Integrity Audit

Mock FDA Regulatory Inspections/FDA Readiness

We assist your company with the best possible preparation for your next FDA inspection. After hundreds of FDA inspections, we know very well how inspections are performed, and what inspectors look for. We can even mimic the FDA inspection atmosphere when more than one inspector is expected. Our mock inspections can include one-day education on FDA readiness and how to interact with the FDA inspector. We will advise your company on which documentation needs to be ready, how to establish an effective war-room to attend the inspection and how to effectively manage all aspect of the inspection, from logistics to record-keeping.

Quality System Assessment/GMP Compliance

Our team of experienced professionals can perform a thorough, in-depth assessment of your quality system against regulatory requirements and guidances, industry best practices and other standards such as USP and ICH. Our detailed risk-based audit report will include recommendations to enhance your weaknesses and can be used as the basis for a remediation/corrective action plan.

Often our clients request us to audit specific elements of their quality system. Some examples of recently performed audits are:

QC Microbiology laboratory

CAPA Systems

Control Change Control

Internal Audit Program

Supplier Certification Program

Training Program and Learning Verification

Facilities and Critical Utility Systems

Validation Program

Internal Audit/Self Inspection

The internal audit program is a regulatory requirement of the FDA and worldwide regulators. This program, when well executed, is your primary line of defense against regulatory inspection findings. However, many FDA regulated companies have weak internal audit programs. This is due to:

• Internal auditors are inherently independent
• Internal auditors lack the education and experience necessary in many areas such as data integrity, computer system validation, laboratory test methods, equipment validation, etc
• Many internal audit programs are not risk-based

We established a very successful internal audit outsourcing model where we perform, twice a year, an in-depth assessment of the different elements of the applicable quality system, with a team of experts covering all the critical areas and elements. This model guarantees you a much more robust internal audit program that saves your company money. Typically you can save up to 50% of your current investment in the internal audit program.

Supplier Control Programs

We can design, implement and/or support a risk-based efficient supplier control program. Each year, our experts perform more than one hundred third party audits worldwide. We are servicing several major global companies auditing their critical suppliers worldwide. During 2016, we performed audits in 15 countries, including India, China, South Korea, Japan, North America, Central and South America and Europe. To learn how you can implement a compliant, risk-based supplier control program at a very reasonable cost, contact us.     

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