Entrerà in vigore il 1 ottobre 2014.
Le modifiche sono le seguenti:
Punti
|
Versione in vigore
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Versione in vigore dal prossimo 10/2014
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6.5
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"Control laboratory premises and equipment should meet the general and specific requirements for Quality Control areas given in Chapter 3." | "Control laboratory premises and equipment should meet the general and specific requirements for Quality Control areas given in Chapter 3. Labortatory 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." |
6.7
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Sono stati eliminati o modificati i seguenti punti: - sampling procedures; - testing procedures and records (including test worksheets and/or laboratory notebooks) - analytical reports and/or certificates;- data from environmental monitoring, where required; - procedures for and records of the calibration of instruments and maintenance of equipment |
Tra i punti deila documentazione che deve essere disponibile nel Controllo Qualità sono stati introdotti: - Procedures describing sampling, testing, records (including test worksheets and/or laboratory notebooks), recording and verifying; - Procedures for and records of the calibrations/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; |
6.8
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"Any Quality Control documentation relating to a batch record should be retained for one year after the expiry date of the batch and at least 5 years after the certification referred to in Article 51(3) of Directive 2001/83/EC" | "Any Quality Control documentation relating to a batch record should be retained following the principles given in chapter 4 on retention of batch documentation" |
6.9
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"For some kind of data (e.g analytical tests results, yields, environmental controls) it is recommended that records are kept in a manner permitting trend evaluation." | "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". |
6.12
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"Reference samples should be representative of the batch of materials of products form 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)." | "Samples should be representative of the batch of materials of products form 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 justify and based on a risk management approach." |
6.13
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"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." | "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." |
6.15
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"Analytical methods should be validated. All testing operations described in the marketing authorisation should be carried out according to the approved methods." | "Testing methods should be validated. A laboratory that is using a testing method and which did not performed the original validation, should verify the appropriateness of the testing method. All testing operations described in the marketing authorisation should be carried out according to the approved methods." |
6.16
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"The results obtained should be recorded and checked to make sure that they are consistent with each other. Any calculations should be critically examined." | "The results obtained should be recorded. Results of parameters identified as quality attribute of as critical should be trended and checked to make sure that they are consistent with each other. Any calculations should be critically examined." |
6.17
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Non è cambiato | E' stato aggiunto, alla lista delle informazioni da registrare, anche il riferimento allo strumento utilizzato per l'analisi |
6.19
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"Special attention should be given to the quality of laboratory reagents, volumetric glassware and solutions, reference standards and culture media. They should be prepared in accordance with written procedures." | "Special attention should be given to the quality of laboratory reagents, solutions, glassware, reference standards and culture media. They should be prepared iand controlled in accordance with written procedures. The level of controls should be commensurate to their use and to the available stability data." |
6.20 (new)
|
paragrafo che non c'era | "Reference standards should be estabilshed as suitable for their intended use. Their qualification and certification as such should be clearly stated and documented. Whenever compendial reference standards from an official recognised source exist, these should prefereably 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 adn is documented). These compendial materials should be used for the purpose described in the appropiate monograph unless otherwise authorised by the National Competent Authority". |
6.20 (old)
6.21 (new)
|
"Laboratory reagents intended for prolonged use should be marked with the preparation date and the signature of the person who prepared them. The expiry date of unstable reagents and culture media should be indicated on the label, together with specific storage condition. In addition, for volumetric solutions, the last date of standardisation and the last current factor should be indicated." | "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 condition. In addition, for volumetric solutions, the last date of standardisation and the last current factor should be indicated." |
6.23 (new)
|
paragrafo che non c'era | "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". |
6.24 (new)
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paragrafo che non c'era | "Used microbiological media and strains should be decontaminated accordin 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." |
6.32 (old)
6.35 (new)
|
"Out of specification or significant atypical trends shoud be investigated. Any confirmed out of specification result, or significant negative trend, should be reported to the relevant competent authorities. The possible impact on batches on the market should be considered in accordance with chapter 8 of GMP Guide and in consultation with the relevant competent authorities." | "Out of specification or significant atypical trends shoud be investigated. Any confirmed out of specification result, or significant negative trend, affecting product batches released on the market should be reported to the relevant competent authorities. The possible impact on batches on the market should be considered in accordance with chapter 8 of GMP Guide and in consultation with the relevant competent authorities." |
| Le parti che seguono non erano inserite nella versione del 2005 | Technical transfer of testing methods | |
6.37 (new)
|
=== | "Prior to transferring a test method, the transferring site should verify that the test method(s) comply with those as described in the Marketing Authorisation or the relevant technical dossier. The original validation of the test method(s) should be reviewed to ensure compliance with current ICH/VICH requirements. A gap analysis should be performed, prior to commencing the technical transfer process." |
6.38 (new)
|
=== | "The transfer of testing methods from one laboratory (transferring laboratory) to another laboratory (receiving laboratory) should be described in a detailed protocol." |
6.39 (new)
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=== | "The transfer protocol should include, but not be limited to, the following parameters: i. Identification of the testing to be performed and the relevant test method(s) undergoing transfer; ii. Identification of the additional training requirements; iii. Identification of standards and samples to be tested; iv. identification of any special transport and storage conditions of test items; v. The acceptance criteria which should be based upon the current validation study of the methodology and with respect to ICH/VICH requirement |
6.40 (new)
|
=== | "Deviations from the protocol should be investigated prior to closure of the technical transfer process. The technical transfer report should document the comparative outcome of the process and should identify areas requiring further test method revalidation, if applicable" |
6.41 (new)
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=== | "Where appropriate, specific requirements described in others European Guidelines, should be addressed for the transfer of particular testing methods (e.g. Near Infrared Spectroscopy)" |
E' stata posta ancora l'attenzione sul fatto che i metodo non solo devono essere validati, ma che qualsiasi modifica al metodo validato deve essere verificata.
E' stata ampliata la parte riguardante il trattamento dei reagenti/standard, ribadendo che va comunque gestita la preparazione, la scadenza e la validità all'apertura, lo stoccaggio, ecc.
E' chiaro come il concetto di Out of Trend sia entrato ormai a far parte della routine di laboratorio e debba essere tenuto in considerazione. La questione era già stata accennata nella versione del 2005 del capitolo ma ora è stata ulteriormente sottolineata.
E' stata ampliata la parte riguardante il trattamento dei reagenti/standard, ribadendo che va comunque gestita la preparazione, la scadenza e la validità all'apertura, lo stoccaggio, ecc.
E' chiaro come il concetto di Out of Trend sia entrato ormai a far parte della routine di laboratorio e debba essere tenuto in considerazione. La questione era già stata accennata nella versione del 2005 del capitolo ma ora è stata ulteriormente sottolineata.
Eventuali dati fuori trend devono quindi essere oggetto di indagine, magari meno impegnativa rispetto un OOS ma comunque tenuti in osservazione.
Infine è stato introdotto il capitolo dell'analytical transfer che non era presente nella precedente (e ancora attuale fino a settembre) edizione del capitolo 6 (Quality Control) del volume 4 delle GMP.
Scusate la lunghezza del post, ma le modifiche erano tante!!!
Aggiornamento del 14/11/14
Vi consiglio anche il post "Update to EU GMP chapter 6 - Quality Control" del blog Inspired Pharma che commenta in modo più ironico le modifiche introdotte!
Infine è stato introdotto il capitolo dell'analytical transfer che non era presente nella precedente (e ancora attuale fino a settembre) edizione del capitolo 6 (Quality Control) del volume 4 delle GMP.
Scusate la lunghezza del post, ma le modifiche erano tante!!!
Aggiornamento del 14/11/14
Vi consiglio anche il post "Update to EU GMP chapter 6 - Quality Control" del blog Inspired Pharma che commenta in modo più ironico le modifiche introdotte!
