Data integrity & ALCOA+

Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends. It would be helpful for data management.

1. Data Integrity and Compliance With Drug: CGMP Questions and Answers Guidance for Industry by USFDA & WWW.PHARMAGUIDELINE.COM Tuhin Reza Deputy Manager, R&DA, Renata Limited DATA INTERITY Based on

2. INTRODUCTION FDA’s authority for CGMP comes from section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The purpose of this guidance is to clarify the role of data integrity in CGMP for drugs, as required in 21 CFR parts 210, 211, and 212. Part 210 covers CGMP in Manufacturing, Processing, Packing, or Holding of Drugs. Part 211 covers CGMP Practice for Finished Pharmaceuticals. Part 212 covers CGMP for Positron Emission Tomography (PET) Drugs.

3. INTRODUCTION FDA expects that all data be reliable and accurate. CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks, based on their process of understanding and knowledge management technologies and business models. Meaningful and effective strategies should consider the design, operation, monitoring systems and controls, based on risk to patient, process, and product. Management’s involvement in and influence on these strategies is essential……..

4. D ata integrity refers to the completeness, consistency, and accuracy of data. Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends. What is data integrity?

5. ALCOA Legible Contemporaneous Original Accurate Attributable Complete, Consistence & Accurate data should be ALCOA

6. ALCOA + Legible Contemporaneous Original Accurate Complete Consistence Enduring Available Attributable

7. Attributable: It indicates for easily identifying Who, Where & When collect the data? If any record is changed, who and when did it must be note down. Source the link data. Legible: Recorded data must be readable & store in durable medium. Contemporaneous: Data recorded must be contemporary in nature. Data should be recorded at the time the data are generated. Actually it must be real time data. Original: Data must be original or certified true copy. For duplication, show the authenticity of true copy. Accurate : Data should be error free and documented amendment . Maintain quality.

8. Complete: Data must be complete in nature. After completion, no alteration and deletion from this date. Any change must be included. Consistence: Data should be chronologically arranged with time stamps including any addition to the original data. Consistence should be included by various audit over the data’s life time. Enduring: The material used to record the data should be a manner which will last long and readable. Recorded in bound paginated note book, controlled work sheet or electric media. Available: Data should be easily accessible whenever needed. Review or audit in life time of the records.

9. Are controls in place to ensure that data is complete? Are activities documented at the time of performance? Are activities attributable to a specific individual? Can only authorized individuals make changes to records? Is there a record of changes to data? Are records reviewed for accuracy, completeness, and compliance with established standards? Are data maintained securely from data creation through disposition after the record’s retention period? For regulatory requirements It may be useful to ask the following questions

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