Question & Answer on Quality Control Part -II AS PER EU Guidelines (EudraLex)

Question & Answer on Quality Control Part II AS PER EU Guidelines (EudraLex)

Question:

What validation is required for testing methods according to the EU GMP?

Answer:

Testing methods should be validated. If a laboratory is using a testing method for which it did not perform the original validation, it should verify the appropriateness of the testing method. All testing operations described in the marketing authorization or technical dossier should be conducted according to approved methods.

Question:

What actions should be taken regarding the results obtained from testing, particularly for parameters identified as quality attributes or critical?

Answer:

The results obtained from testing, especially for parameters identified as quality attributes or critical, should be recorded, trended, and checked to ensure consistency with each other. Any calculations should be critically examined to verify accuracy.

Question:

What data should be included in the records of tests performed according to the EU GMP?

Answer:

The records of tests performed should include at least the following data:

  1. Name of the material or product and, where applicable, dosage form;
  2. Batch number and, where appropriate, the manufacturer and/or supplier;

iii. References to the relevant specifications and testing procedures;

  1. Test results, including observations and calculations, and reference to any certificates of analysis;
  2. Dates of testing;
  3. Initials of the persons who performed the testing;

vii. Initials of the persons who verified the testing and the calculations, where appropriate;

viii. A clear statement of approval or rejection (or other status decision) and the dated signature of the designated responsible person;

  1. Reference to the equipment used.

Question:

What are the requirements for in-process controls, and how should their results be handled according to the EU GMP?

Answer:

In-process controls, including those performed in the production area by production personnel, should be conducted according to methods approved by Quality Control, and the results should be recorded.

Question:

What items require special attention regarding quality, and how should they be prepared and controlled according to the EU GMP?

Answer:

Special attention should be given to the quality of laboratory reagents, solutions, glassware, reference standards, and culture media. They should be prepared and controlled in accordance with written procedures, with the level of controls commensurate to their use and available stability data.

Question:

What requirements apply to reference standards, and what preference is given to compendial reference standards according to the EU GMP?

Answer:

Reference standards should be established as suitable for their intended use, with clear qualification and certification stated and documented. Compendial reference standards from officially recognized sources should preferably be used unless fully justified. The use of secondary standards is permitted once their traceability to primary standards is demonstrated and documented.

Question:

What information should be marked on laboratory reagents, solutions, reference standards, and culture media according to the EU GMP?

Answer:

Laboratory reagents, solutions, reference standards, and culture media should be marked with the preparation and opening date, the signature of the person who prepared them, and the expiry date for reagents and culture media. Specific storage conditions should also be indicated, along with the last date of standardization and the last current factor for volumetric solutions.

Question:

What information should be indicated on containers of substances used for testing operations, and what procedures should be followed according to the EU GMP?

Answer:

The date of receipt of any substance used for testing operations should be indicated on the container, and instructions for use and storage should be followed. In some cases, an identification test and/or other testing of reagent materials may be necessary upon receipt or before use.

Question:

How should culture media be prepared, and what verification should be performed according to the EU GMP?

Answer:

Culture media should be prepared in accordance with the manufacturer’s requirements unless scientifically justified, and the performance of all culture media should be verified prior to use.

Question:

What procedures should be followed for used microbiological media and strains according to the EU GMP?

 

Answer:

Used microbiological media and strains should be decontaminated according to a standard procedure and disposed of in a manner to prevent cross-contamination and retention of residues. The in-use shelf life of microbiological media should be established, documented, and scientifically justified.

Question:

How should results from parameters identified as quality attributes or critical be handled according to the EU GMP?

Answer:

Results from parameters identified as quality attributes or critical should be trended and checked to ensure consistency with each other. Any calculations should be critically examined for accuracy.

Question:

What data should be recorded for tests performed according to the EU GMP?

Answer:

The records of tests performed should include data such as the name of the material or product, batch number, references to relevant specifications and testing procedures, test results including observations and calculations, dates of testing, initials of personnel who performed and verified the testing, a clear statement of approval or rejection, and reference to the equipment used.

Question:

What guidance is provided for reference and retention samples according to the EU GMP?

Answer 10:

Guidance on reference and retention samples is provided in Annex 19.