BSA Cost Effective Validation Approach

For many years, the pharmaceutical, biotech and medical device industries have experience increases in the cost of Validation / Compliance Services. These increases in cost have been driven in part by the continuous increasing validation/compliance consultants cost. Based on this, the pharmaceutical industry is continuously challenging the consulting service providers to offer alternatives in order to reduce cost.

BSA has designed a "Cost Effective Validation Approach" to significantly reduce validation cost. The "Cost Effective Validation Approach" consists of development of validation documentation off-site. Master Plans, Policies, Protocols, Reports, SOPs, etc., being developed off-site will reduce validation costs related to billing rates, office space, utilities, equipment, mileage, or travel expenses and overtime. The overall validation reduction cost savings is estimated to be at least of 20% of the total validation project cost. Table 1 shows an example of this approach applicable for the deliverables associated for equipment qualification.

Table1: Cost Efficient Validation Approach for Equipment Qualification

Regulatory Compliance Services

Our Compliance Consultants consist of former regulatory inspectors and experienced pharmaceutical, biopharmaceutical, and medical device professionals like engineers, specialists, computer experts and analysts.

Pre-Approval Inspections (PAI)

Preparing for a PAI?  What can BSA do for Your Organization?

• Assist our clients in preparing New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) FDA submissions.
• We can audit your application by verifying the authenticity and accuracy of the data contained and generates a report including adverse findings that may have an impact on your company’s ability to manufacture the product in compliance with cGMPs.
• Areas or Processes to be audited will include but not limited to:
• Biobatch Manufacturing: Audit facilities and all records associated with the manufacture of the specific batches (e.g. pivotal clinical, bioavailability, bioequivalence and stability) upon which the application is based and compliance with cGMPs requirements.
• Manufacture of Drug Substance: Audit facilities and all documentation associated with the manufacture of the Active Drug Substance (ADS). Audit will include the review of all starting materials, intermediates, reagents and solvents.
• Excipients Manufacture: Evaluation of the records and data associated with the manufacture of excipients.
• Raw Materials: Audit of facilities for the drug substance and review of data on raw materials to determine compliance with cGMPs requirements. Perform scientific reviews of documentation and data related to raw materials test methods and specifications.
  
• Composition and Formulation of Finished Dosage Form: Evaluation of the composition and formulation to determine qualitatively and quantitatively the acceptability of the information submitted in the application.

• Container/Closure System: Audit the container/closure systems to be used to package the drug product as indicated in the application.

• Labeling and Packaging Controls: Audit facilities compliance with cGMPs requirements, labeling and packaging components associated with the drug product.

• Laboratory Support and Methods Validation: Review of all Analytical Methods and data used as part of the Analytical Method Validation exercises.

• Product Stability: Review of the proposed drug product stability protocol for commercial batches and data submitted in support of the expiration dating period proposed for the product in the application.

• Manufacturing Batches Scale-Up: Verify all documentation to establish the scale-up approach from the pre-approval batches to the full scale validation batches.

• Facilities & Personnel: Review that all facilities and personnel associated with the manufacturing process meet cGMPs requirements and have been trained respectively.

• Equipment Qualification: Audit that all equipment and systems used in the manufacturing process have been qualified (IQ, OQ, PQ), following cGMPs and guidance requirements.

• Process Validation: Audit that all data that support specific validation of processing operations, e.g. sterilization, environmental monitoring, equipment qualification and associated manufacturing operations.      

Post-Approval Inspections (PAI)-General Inspections

• BSA will audit the manufacturing process to assure that any changes in manufacturing and process control are in full compliance with cGMPs regulations. We will also verify and confirmed that all changes are documented appropriately in the supplement applications or annual reports as applicable and required by the code of federal regulations (21 CFR).

• BSA will audit and confirm that NDA/ANDA requirements concerning Adverse Reaction Reports (ARR), NDA Field Alerts and Annual Reports are in full compliance.

• Documentation to be audited as part of the Post Approval Inspection will include but not limited to:

• Change Control Program
• Corrective Action –Preventive Action (CAPA)
• Special Supplements- Changes Being Effected (CBE)
• SOPs, Specifications & Master Formulas
• Annual Product Reviews (APRs)
• Re-processing records
• Records of In-process or Finished Product Rejection
• Deviations from Laboratory Procedures
• Deviations from written and approved procedures
• Investigation of discrepancies and batch failures
• Investigation of return drug products
• Stability Test Results

Computer Systems Validation (CSV) Services

• CSV Master Plan
• Requirements & Specification Generation
• Test Plan & Protocol Development
• Commissioning
• Qualification Testing
• Risk Management
• GxP System Assessment
• Remediation Planning
• SOPS, Training & Summary Reports
• Change Control