Principle
- Quality Control is concerned with sampling, specifications and testing as well as the organisation, documentation and release procedures which ensure that the necessary and relevant tests are carried out, and that materials are not released for use, nor products released until their quality has been determined to be satisfactory. Quality Control is not confined to laboratory operations, but should be involved in all decisions, which may concern the quality of the product.
General
- Samples for laboratory testing should be taken in a manner so as to avoid risk of microbial contamination of the product and mix-up of samples.
- Documented procedures for quality control should be established, implemented and maintained. The procedures should ensure that the product meets specifications.
- Solutions, which are in direct contact with the product during manufacture, should be sterile. If prepared in-house, they should be prepared in an appropriate environment and should comply with the requirements of the test for sterility.
Sampling
- Sampling should be conducted in accordance with approved written procedures that describe:
- the method of sampling;
- the equipment to be used;
- the number and quantity of the samples to be taken;
- the type and condition of the sample container to be used;
- any special precautions to be observed;
- the storage conditions for samples;
- Instructions for the cleaning and storage of sampling equipment.
Testing
- Screening tests for donor suitability should be carried out by a competent laboratory. Where required by legislation the laboratory should be licensed by the regulatory authority for therapeutic products.
- Screening tests should be conducted according to documented procedures and should include (or refer to) the acceptance criteria for individual tests.
- Tests should be performed using qualified equipment and methodology, which has been appropriately validated.
- Testing of samples should take into account any factors (including pooling of samples), which may cause dilution sufficient to alter test results.
- The quality of the laboratory testing should be regularly assessed by the participation in a formal system of proficiency testing, such as an external quality assurance program.
- Test records should include at least the following data:
- reference to the donation;
- details of equipment and materials used;
- references to the relevant specifications and testing procedures;
- test results, including observations and calculations;
- date(s) of testing;
- identification of the person(s) who performed the testing;
- identification of the person(s) who reviewed the results, including a check of calculations, where applicable.
- Laboratory test results, which do not satisfy, specified acceptance criteria should be handled according to documented procedures. The procedures should ensure that products not meeting acceptance criteria are quarantined, the out of specification investigated and if applicable, samples are re-tested.
- The retention time, storage conditions, quantity and expiry of donor test samples retained for retesting, should be determined on a risk basis and take regulatory requirements into account.
- In order to ensure both the reliability of the manufacturing process and the quality of the final product there should be routine microbial contamination testing. Where contamination is demonstrated, records should show the corrective action taken.
Product release
- There should be a system of quarantine for all products to ensure that they are not released for supply until they have met all defined acceptance criteria, including regulatory requirements. There should be a documented procedure, which defines the requirements for release of product for supply. Records of product release should be maintained.
- The manufacturer should ensure that where Tissue and Cellular Therapy Products do not meet the product specifications, a review of the product should be undertaken. Only when a risk based approach and/or regulatory requirements have been met can such products to be released.
- Procedures for the management of products where all requirements have not been fulfilled should be established and maintained. Records including actions taken should be documented and maintained.
- Products not released should be identifiable from those, which conform to specification and have received their final inspection. Appropriate records should be maintained. In the event that the final product fails release, and where applicable, a check should be made to ensure that other products from the same donation are identified. Products prepared from previous donations (where applicable) by the same donor should also be identified. There should be an immediate update of the donor record to ensure that the donor cannot make a further donation, if appropriate.
- Where applicable, autologous Human Blood or Human Blood Components, Human Tissue and Human Cellular Therapy Products from donors with repeatedly reactive mandatory screening tests, with the intended purpose of reintroduction into that donor, records should be available to demonstrate the rationale for this use. Where applicable, product should be appropriately labelled. Authority for the release of this product should be documented.
- There should be a documented procedure, which defines the disposal requirements for product not suitable for use. Product, which is to be discarded, should be labelled to reflect its status, stored in a dedicated and secure area, and disposed of. There should be a record of discarded product, including the reason for discard.