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

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

Question:

What does Quality Control involve, and why is its independence from Production considered fundamental?

Answer:

Quality Control encompasses sampling, specifications, testing, organization, documentation, and release procedures to ensure that necessary tests are conducted, and materials or products are not released until their quality is deemed satisfactory. It extends beyond laboratory operations to encompass all decisions affecting product quality. The independence of Quality Control from Production is considered fundamental as it ensures unbiased assessment and oversight, contributing to the effective operation of Quality Control processes.

Question:

What requirements should be met by the Quality Control Department of a holder of a manufacturing authorization?

Answer:

The Quality Control Department should be independent from other departments and be overseen by an individual with suitable qualifications and experience. This individual should have access to one or more control laboratories and ensure that adequate resources are available to effectively carry out all Quality Control arrangements.

Question:

What are the principal duties of the head of Quality Control?

Answer:

The head of Quality Control is responsible for summarizing the department’s duties, which include establishing, validating, and implementing quality control procedures, overseeing the control of reference and/or retention samples, ensuring proper labeling of containers, monitoring product stability, and participating in investigations related to product quality. These operations should be conducted in accordance with written procedures and documented as necessary.

Question:

What factors should be considered in the assessment of finished products?

Answer:

The assessment of finished products should consider various factors, including production conditions, results of in-process testing, review of manufacturing documentation (including packaging), compliance with Finished Product Specifications, and examination of the final finished pack.

Question:

What access should Quality Control personnel have in production areas?

Answer:

Quality Control personnel should have access to production areas for sampling and investigation purposes as appropriate.

Question:

What additional duties does the Quality Control Department have beyond the principal duties of the head of Quality Control?

Answer:

In addition to the principal duties of the head of Quality Control, the Quality Control Department is responsible for tasks such as establishing, validating, and implementing all quality control procedures, overseeing the control of reference and/or retention samples, ensuring proper labeling of containers, monitoring product stability, and participating in complaint investigations. All these operations should be carried out according to written procedures and documented when necessary.

Question:

What requirements should be met regarding control laboratory premises and equipment according to EU GMP?

Answer:

Control laboratory premises and equipment should adhere to both general and specific requirements outlined in Chapter 3 for Quality Control areas. It’s advised not to routinely move laboratory equipment between high-risk areas to prevent accidental cross-contamination. Specifically, the microbiological laboratory should be arranged to minimize the risk of cross-contamination.

Question:

What considerations should be taken regarding personnel, premises, and equipment in the laboratories?

Answer:

Personnel, premises, and equipment in the laboratories should be suitable for the tasks dictated by the nature and scale of manufacturing operations. It is essential to ensure that these aspects are appropriate to maintain the quality and integrity of the manufacturing process.

Question:

Under what circumstances can the use of outside laboratories be accepted according to the EU GMP?

Answer:

The use of outside laboratories can be accepted for specific reasons, provided it is in conformity with the principles outlined in Chapter 7 on Contract Analysis. However, this utilization should be explicitly stated in the Quality Control records to ensure transparency and accountability.

Question:

What aspects of laboratory documentation should be readily available to the Quality Control Department?

Answer:

The following details should be readily available to the Quality Control Department as part of laboratory documentation:

  1. Specifications;
  2. Procedures describing sampling, testing, records (including test worksheets and/or laboratory notebooks), recording, and verifying;

iii. Procedures for and records of the calibration/qualification of instruments and maintenance of equipment;

  1. A procedure for the investigation of Out of Specification and Out Of Trend results;
  2. Testing reports and/or certificates of analysis;
  3. Data from environmental (air, water, and other utilities) monitoring, where required;

vii. Validation records of test methods, where applicable.

Question:

What should laboratory documentation adhere to according to EU GMP?

Answer:

Laboratory documentation should adhere to the principles outlined in Chapter 4. This ensures that documentation is comprehensive, accurate, and consistent, meeting the requirements for effective Quality Control.

Question:

Why is it important for the Quality Control Department to have readily available access to specific details of laboratory documentation?

Answer:

It is important for the Quality Control Department to have readily available access to specific details of laboratory documentation to ensure effective monitoring, verification, and validation of processes and results. Having access to this documentation enables the department to uphold quality standards, identify deviations or anomalies, and take appropriate corrective and preventive actions when necessary.

Question:

What kinds of data should be recorded in a manner allowing trend evaluation, and what action should be taken regarding out of trend or out of specification data?

Answer:

Data such as test results, yields, and environmental controls should be recorded in a manner that permits trend evaluation. Any out of trend or out of specification data should be addressed promptly and subjected to investigation to identify the root cause and implement appropriate corrective actions.

Question:

Apart from the information included in batch documentation, what other raw data should be retained and readily available according to the EU GMP?

Answer:

In addition to the information included in batch documentation, other raw data such as laboratory notebooks and/or records should be retained and readily available. This ensures comprehensive documentation and facilitates traceability and accountability in Quality Control processes.

Question:

What aspects should approved written procedures for sample taking describe according to the EU GMP?

Answer:

Approved written procedures for sample taking should describe:

  1. The method of sampling;
  2. The equipment to be used;

iii. The amount of the sample to be taken;

  1. Instructions for any required sub-division of the sample;
  2. The type and condition of the sample container to be used;
  3. The identification of containers sampled;

vii. Any special precautions to be observed, especially with regard to the sampling of sterile or noxious materials;

viii. The storage conditions;

  1. Instructions for the cleaning and storage of sampling equipment.

Question:

What should samples be representative of, and what additional samples may be taken according to the EU GMP?

Answer:

Samples should be representative of the batch of materials or products from which they are taken. Additional samples may also be taken to monitor the most stressed part of a process, such as the beginning or end. The sampling plan should be appropriately justified and based on a risk management approach.

Question:

What information should sample containers bear, and how should they be managed according to the EU GMP?

Answer:

Sample containers should bear a label indicating the contents, with the batch number, the date of sampling, and the containers from which samples have been drawn. They should be managed in a manner to minimize the risk of mix-up and to protect the samples from adverse storage conditions.