The Value of Manufacturing Record Review
Background
Manufacturing Batch Records may also be called “Production Records,” “Production Batch Records,” “Batch Production and Control Records,” or “Device History Records (DHR)” depending on your product type. Manufacturing Batch Record Review provides valuable benefits to the manufacturing process, especially within regulated industries such as pharmaceuticals, biotechnology, medical devices, cosmetics, and food and beverage. Regardless of the type of product you are manufacturing, a thorough, well-documented manufacturing record review is an essential part of making any high-quality product.
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Compliance with Regulations
Compliance with local, state, and federal regulations must be considered when manufacturing any product. Not only should you consider the regulations for the location the product is manufactured, but also for any regions where the product will be marketed, distributed, or sold. The batch record review helps to ensure that the manufacturing process adheres to Good Manufacturing Practices (GMP or cGMP) and other regulatory requirements. This is important for regulatory compliance and helps to avoid costly fines, sanctions, and product detainment.
Quality Assurance for the Manufactured Product
A thorough manufacturing record review (Batch Record / Production Record / DHF) confirms that the batch is manufactured according to predefined quality standards and specifications. This is key to maintaining product integrity, reproducibility, and consumer trust. Each and every product unit (drug, device, cosmetic, etc.) should meet the predefined product specifications, labeling and testing requirements.
Product Consistency
Product Consistency helps to ensure that every batch of product is consistent in quality and performance. The manufacturer is also ensuring that products meet specifications to avoid potentially adulterated products. Product consistency ensures the manufacture of high quality products that meet functional requirements and product labeling requirements.
Traceability
Manufacturing Traceability means that the records provide full traceability of the production process from raw materials to finished product. A raw material in this instance can be a component, ingredient, chemical, color additive, API, or biological matter. Full traceability of your manufacturing process is also critical for identifying and addressing the root cause in the event of a quality issue or product recall.
Accountability
Accountability assigns responsibility for specific tasks and steps within the manufacturing process, creating clear roles among staff and management. It is important to be able to trace who performed what steps and when; when a sample was taken; or who documented a test result. The manufacturing batch record creates a formal log that keeps every participant accountable for their part in the manufacturing process.
Continuous Improvement
Continuous Improvement is a key part of the Quality System (Quality Management System, or QMS). It identifies trends, variances, and opportunities for process improvements. This can lead to more efficient operations and reduced costs over time. Continuous improvement can also eliminate future non-conformances or deviations.
Data Integrity
Data Integrity ensures the accuracy, completeness, and reliability of the production data, which is vital for decision-making, GMP Manufacturing, and regulatory submissions. A thoughtful data integrity plan is an essential part of GMP manufacturing. Data integrity should be considered when reviewing a manufacturing batch record. For more information look to ALCOA+ and US FDA 21 CFR Part 11.
Risk Management
Risk Management helps to identify potential risks and implement Corrective And Preventive Actions (CAPAs) to prevent the occurrence of similar issues in future batches. A well documented manufacturing record allows you to use manufacturing data to evaluate potential risks and make process & product improvements.
Customer Confidence
Well documented manufacturing records build and maintain confidence with customers and stakeholders by demonstrating a commitment to quality and compliance. Customer confidence builds with consistent, high quality products that are built on a robust quality system with supporting records and data.
Audit Readiness
Audit Readiness keeps the manufacturing facility audit-ready at all times, as manufacturing batch records may be reviewed during audits by internal personnel or external regulators. Manufacturing Batch Records are relied on by companies to demonstrate adequate process controls and the manufacture of conforming products.
Legal Defense
Manufacturing Batch Records provide a documented history of the production process that can be used as evidence in legal situations to demonstrate compliance to regulatory requirements and product specifications.
Operational Efficiency
Operational Efficiency pinpoints bottlenecks, waste, and inefficiencies in the manufacturing process, allowing for streamlining and optimization of workflow. The data collected in manufacturing batch records can be used to improve operational efficiency and reduce product and process risk.
Market Access and Expansion
Manufacturing Batch Records facilitate approval by regulatory authorities in different markets, potentially allowing for greater market access and expansion. Manufacturing records demonstrate compliance with regulations, product standards, and industry expectations. These records create a foundation for maintaining market access and keep a company eligible to expand to new markets or introduce new products. For example, market access would be suspended when companies are under a Warning Letter from the US FDA. The Warning Letter may identify a violation such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.
SUMMARY
At BatchWize, reviewing a manufacturing record is more than a ”check the box” activity. It is important that the manufacturing record is accurate and complete, as it supports the 14 items described above. Before conducting the review of a Manufacturing Batch Record, be sure that the record is complete and that a trained individual is conducting the review. The manufacturing records must stand alone and be easily understood by future auditors, FDA investigators, and quality personnel. Remember that you’re not just creating a product - but a legacy!
Need More Information?
If you have any questions on any of these points, please feel free to reach out to BatchWize directly. We help our clients get their products to market quickly, and keep them there! BatchWize is a highly trained team that specializes in Manufacturing Record Review and Product Release. We partner with medical device, life science, pharmaceutical, biologic, food, cosmetic, and wellness companies to save our clients time and money. BatchWize provides the efficient review of Quality Records and works with our customers to minimize manufacturing costs.
Learn more at: BatchWize.com or Contact BatchWize.