How to Organize the Quality Agreement for Drug Products Manufacturing

Posted on April 16, 2023April 16, 2023 by admin

A quality agreement is a crucial document that defines the responsibilities and expectations of the parties involved in the manufacturing of pharmaceutical products. The quality agreement helps in ensuring that the product is produced in compliance with the regulatory requirements and also meets the quality standards. One of the essential aspects of the quality agreement is Read more about How to Organize the Quality Agreement for Drug Products Manufacturing[…]

Best Practices of CSV & 21 CFR Part 11 Compliance

Posted on January 31, 2021May 9, 2021 by admin

The cost of compliant CSV can be as much, if not more than the remaining tasks required for system development and implementation. A balance must be reached in order to achieve compliance while minimizing cost of CSV. There are specific industry best practices for effectively controlling the cost of system validation. The cost of longer-term Read more about Best Practices of CSV & 21 CFR Part 11 Compliance[…]

Data Integrity & 21 CFR Part 11 Compliance Requirements

Posted on January 31, 2021May 10, 2021 by admin

21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using: Electronic records (ER), and electronic signatures (ES). Each title of the CFR addresses a different regulated area: 21 CFR relates to Pharmaceuticals and Medical Devices. Part 11 Read more about Data Integrity & 21 CFR Part 11 Compliance Requirements[…]

FDA expectation from you during Design Control portions of Inspections

Posted on July 31, 2020July 31, 2020 by admin

Subsystems interacting with The Design Control Process Management Controls Production and Process Controls Corrective and Preventive Action Document and Record Control Labeling and Packaging Control Risk Management Change Control QSIT Design control requirements Your Firm must have a 21 CFR 820.30 compliant design control process prior to submitting a 510(k), as well as during IDE Read more about FDA expectation from you during Design Control portions of Inspections[…]