What are the responsibilities of a Quality Control?( As per EudraLex Vol-4 & USFDA)
Control laboratory premises and equipment should meet the general and specific requirements for Quality Control areas given in Chapter 3.
Laboratory equipment should not be routinely moved between high risk areas to avoid accidental cross-contamination. In particular, the microbiological laboratory should be arranged so as to minimize risk of cross-contamination.
The personnel, premises, and equipment in the laboratories should be appropriate to the tasks imposed by the nature and the scale of the manufacturing operations. The use of outside laboratories, in conformity with the principles detailed in Chapter 7, Contract Analysis, can be accepted for particular reasons, but this should be stated in the Quality Control records.
Laboratory documentation should follow the principles given in Chapter 4. An important part of this documentation deals with Quality Control and the following details should be readilyavailable to the Quality Control Department:
Procedures describing sampling, testing, records (including test worksheets and/or laboratory notebooks), recording and verifying;
Procedures for and records of the calibration/qualification of instruments and maintenance of equipment;
A procedure for the investigation of Out of Specification and Out Of Trend results;
Testing reports and/or certificates of analysis;
Data from environmental (air, water and other utilities) monitoring, where required;
Validation records of test methods, where applicable.
Any Quality Control documentation relating to a batch record should be retained following the principles given in chapter 4 on retention of batch documentation.
Some kinds of data (e.g. tests results, yields, environmental controls) should be recorded in a manner permitting trend evaluation. Any out of trend or out of specification data should be addressed and subject to investigation.
In addition to the information which is part of the batch documentation, other raw data such as laboratory notebooks and/or records should be retained and readily available
The sample taking should be done and recorded in accordance with approved written procedures that describe:
-The method of sampling;
-The equipment to be used;
The amount of the sample to be taken;
-Instructions for any required sub-division of the sample;
-The type and condition of the sample container to be used;
-The identification of containers sampled;
Any special precautions to be observed, especially with regard to the sampling of sterile or noxious materials;
The storage conditions;
Instructions for the cleaning and storage of sampling equipment.
Samples should be representative of the batch of materials or products from which they are taken. Other samples may also be taken to monitor the most stressed part of a process (e.g. beginning or end of a process). The sampling plan used should be appropriately justified and based on a risk management approach.
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.
Further guidance on reference and retention samples is given in Annex 19.
Testing methods should be validated. A laboratory that is using a testing method and which did not perform the original validation, should verify the appropriateness of the testing method. All testing operations described in the marketing authorisation or technical dossier should be carried out according to the approved methods.
The results obtained should be recorded. Results of parameters identified as quality attribute or as critical should be trended and checked to make sure that they are consistent with each other. Any calculations should be critically examined.
The tests performed should be recorded and the records should include at least the following data: i. Name of the material or product and, where applicable, dosage form;
Batch number and, where appropriate, the manufacturer and/or supplier;
References to the relevant specifications and testing procedures;
Test results, including observations and calculations, and reference to any certificates of analysis;
Dates of testing;
Initials of the persons who performed the testing;
Initials of the persons who verified the testing and the calculations, where appropriate;
A clear statement of approval or rejection (or other status decision) and the dated signature of the designated responsible person;
Reference to the equipment used.
All the in-process controls, including those made in the production area by production personnel, should be performed according to methods approved by Quality Control and the results recorded.
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. The level of controls should be commensurate to their use and to the available stability data.
Reference standards should be established as suitable for their intended use. Their qualification and certification as such should be clearly stated and documented. Whenever compendial reference standards from an officially recognised source exist, these should preferably be used as primary reference standards unless fully justified (the use of secondary standards is permitted once their traceability to primary standards has been demonstrated and is documented). These compendial materials should be used for the purpose described in the appropiate monograph unless otherwise authorised by the National Competent Authority.
Laboratory reagents, solutions, reference standards and culture media should be marked with the preparation and opening date and the signature of the person who prepared them. The expiry date of reagents and culture media should be indicated on the label, together with specific storage conditions. In addition, for volumetric solutions, the last date of standardisation and the last current factor should be indicated.
Where necessary, the date of receipt of any substance used for testing operations (e.g. reagents, solutions and reference standards) should be indicated on the container. Instructions for use and storage should be followed. In certain cases it may be necessary to carry out an identification test and/or other testing of reagent materials upon receipt or before use.
Culture media should be prepared in accordance with the media manufacturer’s requirements unless scientifically justified. The performance of all culture media should be verified prior to use.
Used microbiological media and strains should be decontaminated according to a standard procedure and disposed of in a manner to prevent the cross-contamination and retention of residues. The in-use shelf life of microbiological media should be established, documented and scientifically justified.
Animals used for testing components, materials or products, should, where appropriate, be quarantined before use. They should be maintained and controlled in a manner that assures their suitability for the intended use. They should be identified, and adequate records should be maintained, showing the history of their use.
Sec. 211.22 Responsibilities of quality control unit(As Per USFDA)
(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.
(b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit.
(c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.
(d) The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.
EU Guidelines for
Good Manufacturing Practice for
Medicinal Products for Human and Veterinary Use
Chapter 6: Quality Control