21 CFR Part 11 - Requirements and New Scope - - BioPharm International

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21 CFR Part 11 - Requirements and New Scope


BioPharm International


Which Records Must Be Retained? There is no question that certain laboratory records must be retained according to predicate rules. These include raw data, instrument control, processing parameters (metadata), and results. There is also no question that Part 11 applies when we use electronic records instead of paper for these records. Typically, analyses and evaluation of the results of the final product is the last check before the product is released to the market. Laboratory systems that perform such analyses are considered high risk because errors that are not identified at this stage cannot be recovered. Therefore, all Part 11 controls discussed in this paper should be implemented, the most important being:

  • Access to the system and data should be limited and controlled.
  • The computer should have a built-in electronic audit trail that records all changes to records made by operators (for example, manual reprocessing of chromatograms).
  • Original data (like chromatographic raw data) should be kept in electronic form together with metadata and final results.
  • Handwritten signatures and electronic signatures should be linked to electronic records.
  • Systems must be validated according to the requirements of predicate (GxP) rules.

Other systems, like word processors used to write validation reports, are not so critical, and not all Part 11 controls need to be implemented. Validation efforts for such systems should include a well documented installation, but there is no need for extensive testing.

The final decision on whether records fall under the scope of Part 11 and which controls should be implemented should be based on a risk assessment and on the business practices applied in specific laboratories.

More details of the new scope of Part 11 are available in a previously published article.7

References 1. FDA. Code of Federal Regulations, Title 21, Part 11 electronic records; electronic signatures; final rule. Federal Register 1997; 62(54):13429-13466.

2. ISPE. The good automated manufacturing practices (GAMP) guide for validation of automated systems in pharmaceutical manufacture, GAMP 4. Tampa (FL): ISPE; 2001.

3. Huber L. Validation of computerized analytical and networked systems. Boca Raton (FL): Interpharm Press; 2002.

4. Huber L, Winter W. Implementing 21 CFR Part 11 — electronic signatures and records in analytical laboratories, part 4 — long term archiving and ready retrieval. BioPharm 2000; 13(6):58-64.

5. Huber L. Case study: web applications. In: Wingate G, editor. Computer systems validation. Boca Raton, FL: Interpharm/CRC Press; 2003.

6. FDA. Guidance for industry: Part 11, electronic records; electronic signatures — scope and application. (Draft February 2003, Final version August 2003). Available at URL: www.fda.gov/cder/guidance/5667fnl.pdf.

7. Winter W, Huber L. Part 11 is not going away: the new electronic records draft guidance. BioPharm International 2003; 16(5):28-34.


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