04.11.2013 |

LOGFILE No. 21/2012 - Laboratory Controls - GMP Audit Questions

Typical Audit Questions: Laboratory Controls



Typical audit questions Assessment Notes CFR reference EU GMP Guideline
yes/met partly met/ accepted partly met/
not accepted
Laboratory controls
(see also PIC/S PI023 Aide Mémoire „Inspection of Pharmaceutical Control Laboratories“)
1. Are there adequate written instructions that ensure that raw materials, containers, in-process materials, labels and products correspond with the actual standards (specifications) with regard to identity, strength, quality and purity?           211.22d
Part II: 11.11
2. Are these instructions authorized by quality assurance?           211.160a 1.3i + ii
Part II: 11.12

3. Do the testing methods comply with those described in the Marketing Authorization or Regulatory Filings. If there is a Contact in place for the product, are the contract requirements being satisfied?

Part II: 13.17
A16: 3.1
4. Do all the specifications, sampling plans and analytical procedures have a scientific basis?           211.160b 1.3
Part II: 11.12
5. Are there written instructions for calibrating instruments, measuring and recording devices with exact specifications, schedules, limits for  accuracy and precision and procedures in the event of deviations?           211. 160b4 3.41
6.7 + 6.19
Part II: 12.82
6. Are there complete calibration records?           211.194d 4.29, 6.7
7. Do premises and equipment of control laboratories meet the specific tasks performed in the particular lab?             6.5
8. Have the precision, sensitivity, selectivity and reproducibility of the test methods been validated?           211.165e
1.3iii, 6.15
Annex 15: 22
Annex 16: 8.1c
Part II: 12.8
9. Is there a written test program designed to assess the stability characteristics of products?           211.166 6.2 + 6.23
Part II: 11.5
10. Is a sufficient number of batches of each product tested to determine the stability?           211.137
Part II: 11.5
11. Are the stability tests that are carried out fully documented and archived?           211.194e Part II: 11.5
12. Is there a written procedure for handling OOS- results?           211.160a 6.32
Part II: 11.15
13. Are all deviations from instructions documented and investigated?           211.100b
1.3vi, 5.15
Part II: 2.16
Annex 16: 8.1d
14. Are trend evaluations performed on analytical test results, yields and environmental controls?             6.9
15. Are changes in methods documented and compared to the established methods?           211.194b  
16. Are reagents and standards manufactured and labelled in accordance with written procedures?             6.19–21
Part II: 11.16
17. Is the handling of reference standards  (source and manufacture, storage, analysis, use) documented?           211.194c Part II:


These 17 questions are an extract from the "Checklist GMP-Inspections" by Maas & Peither GMP Publishing. 

This questionnaire contains 650 questions typically asked during GMP inspections, arranged by subject-matter. The information sources include the 21 CFR 210/211/11 and the EU-GMP-Guide Parts I and II.

>>>More information: Checklist GMP-Inspections