IF YOUR GOAL IS TO BE “INSPECTION READY” AT ANYTIME, Let us help with…
PDUFA,GDUFA,OMUFA,MDUFA, MDR, 51OK, SPL,LISTING (compounding 503[A][B]).
Standard Operating Procedures (SOPs): Develop and implement comprehensive SOPs that outline the step-by-step instructions for all critical processes and operations within the manufacturing facility. SOPs should cover areas such as manufacturing, quality control, cleaning and sanitation, equipment maintenance, and documentation practices.
Quality Management System (QMS): Establish a robust QMS that encompasses all aspects of quality assurance, quality control, and quality management. This includes processes for document control, change control, deviation management, corrective and preventive actions (CAPA), complaints handling, and internal audits.
Batch Record Documentation: Maintain complete and accurate batch records for each batch of pharmaceutical products manufactured. These records should include all relevant information about the manufacturing process, materials used, equipment used, personnel involved, and quality control tests performed.
Product Testing and Analysis: Conduct comprehensive testing and analysis of raw materials, in-process samples, and finished pharmaceutical products to ensure their quality, potency, purity, and safety. This includes testing for identity, strength, dissolution, content uniformity, microbial limits, and stability.
Facility and Equipment Validation: Validate manufacturing facilities, cleanrooms, and critical equipment to ensure they meet specified requirements and are capable of consistently producing quality products. This includes qualification and validation of HVAC systems, water systems, manufacturing equipment, and analytical instruments.
Personnel Training: Provide appropriate training to all personnel involved in manufacturing, quality control, and quality assurance to ensure they have the necessary knowledge, skills, and competencies to perform their roles effectively and in compliance with FDA regulations.
Adverse Event Reporting: Establish procedures for the timely and accurate reporting of adverse events associated with your pharmaceutical products. Adverse events include any unexpected or serious side effects, product defects, or quality issues that may impact patient safety.
FDA Inspections and Audits: Prepare for and cooperate with FDA inspections and audits. This involves maintaining complete and organized documentation, ensuring facility cleanliness and compliance, addressing any findings or observations from previous inspections, and promptly implementing corrective actions.
Labeling and Advertising Compliance: Ensure that all product labeling, packaging, and promotional materials comply with FDA regulations. This includes accurate product information, appropriate use instructions, proper warning statements, and adherence to labeling requirements for prescription drugs and over-the-counter products.
Adherence to Regulatory Requirements: Stay updated with FDA regulations and guidelines applicable to pharmaceutical manufacturing, including changes to GMP requirements, labeling regulations, drug approval processes, and post-marketing surveillance requirements PDUFA,GDUFA,OMUFA,MDUFA.
Recall and Complaint Management: Establish procedures for managing product recalls, withdrawals, and complaint handling. This includes promptly investigating and addressing product complaints, implementing corrective actions, and communicating effectively with the FDA and customers, if necessary.
Documentation and Record-Keeping: Maintain thorough and organized documentation and records related to manufacturing, quality control, quality assurance, testing, validation, training, and any other relevant processes. These records should be readily accessible for FDA inspections and audits.