PRAFULL AVHAD

Key Responsibilities:

• Regulatory Compliance & Documentation:
• Managing applications on the FDA Website for GMP certificates, plant layout approvals, and test licenses.
• Processing WHO-GMP applications, including Certificate of Pharmaceutical Product (COPP).
• Handling applications for WC license through the CDSCO Sugam Portal.
• Audits & Compliance:
• Leading WHO-GMP, FDA, and customer audits, ensuring compliance with regulatory requirements.
• Preparing Corrective and Preventive Action (CAPA) reports to address audit findings.
• Process Validation & Risk Assessment:
• Managing process validation profiles, including protocol preparation and reporting.
• Conducting Annual Product Quality Review (APQR) and risk assessments for process improvements.
• Documentation & SOP Management:
• Preparing Batch Manufacturing Records (BMR), Master Formula Records (MFR), Equipment Change Records (ECR), and Test Data Sheets (TDS).
• Developing and revising Standard Operating Procedures (SOPs) to align with regulatory standards.
• Quality Management System (QMS) Activities:
• Overseeing change control, deviations, reprocessing, returned goods, and incident reporting.
• Vendor Qualification & Training:
• Evaluating vendor qualifications to ensure compliance with pharmaceutical standards.
• Conducting training sessions and self-inspection programs for continuous improvement.
• In-Process Quality Assurance:
• Performing line clearance before batch charging and dispensing raw materials.
• Sampling finished goods and issuing QA documents and formats.
• Basic Knowledge of Production & Equipment Handling:
• Familiarity with pharmaceutical production processes and equipment.

• Line Clearance before Batch Charging:
• Please ensure that the area is clean and free from previous product traces or documents. Verification of equipment cleaning and status labels (cleaned/released). Confirming the availability of approved BMR/BPR and approved batch details.
• Checking
• For the readiness of raw materials and packaging materials.
• Handling of Batch Production Record (BPR):
• Line-wise review and real-time documentation checks during manufacturing and packing. Ensuring compliance with Good Documentation Practices (GDP). Escalation of deviations or discrepancies to QA/QC and proper recording in logbooks. Issuance, reconciliation, and archival of BPRs as per SOP.
• Handling of Sampling:
• Performing in-process and finished product sampling as per sampling plan. Environmental monitoring sampling (if involved). Labelling, coding, and proper documentation of sample details.
• Coordinationn with QC for timely sample transfer and analysis.
• Ensuring sample integrity and avoidance of contamination during sampling.