22017 European Authoriy's inspection Findings inthe Arca Validation Qualifcation- ECA Academy + * * A dl ECA | foccor co | if e deg a | tsfornaation Source EcAAcademy > GMPNews > News Detail 01.02.2017 European Authority's Inspection Findings in the Area Validation/Qualification ‘The US American Food and Drug Administration (FDA) has long been publishing inspection results in so-called Warning Letters. Those letters are freely available onthe engish + years now, major violations of GMP have been published in a European inspection database. The Grit maepuiawy swsuity (MHRA does this ina much more detailed way. Read the following examples published by the Mr: eutopeapicAtdhastlyésidn spabtiostibirtcimeeois. the Area Valigation/Qualifgation MHRA's inspection deficlencies 2015, the topic validation occupies rank 8, However, no critical deficiency was ‘ajor" deficiencies concertigéthe validation report and changes to the validation plans. | Fann ya Sil Mila gi gt y SV All ui) tl Regarding the topic qualification, the MHRA presents the following exemplary deficiencies: Inthe top 10. found. Most” * Lack of design phase (DQ, URS) for newequioment ou. ore» * Qualification documents provided by equipment suppliers were not integrated into the company's pharmaceutical quality system to ensure appropriate review. * The use of suppliers’ documentation for the qualification was criticised a second time: the 0Q protocol for an HVAC system obtained from a supplier hadn't been compared and checked with the company's requirements prior to its approval = One heat tunnel equipment hadn't been fully qualified in the OQ. With regard to the topic cleaning validation, the MHRA criticised that: «= The effective removal of organic compounds couldn't be assured, * The effectiveness of sprayballs used for vessel cleaning hadn't been demonstrated nor controlled. * The permitted limits for carryover of organic molecules had neither been set nor risk assessed. * No swab samples had been taken -in particular from difficult to clean areas where other methods or determining residues may not be effective. * There was no scientific rationale to support the selection of products used for the cleaning validation, Concerning process validation, the MHRA gave the following examples deficiencies: *= The performance and process validation activities didn't include any assessment of al critical parameters (e.g. tablet dimensions and embossing). * Not every aspect of manufacturing was covered by process validation (e.g. the use of small coating pans as opposed to the validated automated system), * Validation batches were released before process qualification had been completed, Itis interesting to note that the MHRA criticised twice that the companies inspected had no formal processes for implementing, ‘changes in the GMP regulations. Annex 15 - which became applicable as revised version in October 2015 - had been explicitly mentioned once. You can find the complete MHRA's report on GMDP findings on their website. (© 2017 ECA Foundation, Mannheim itplwwn gmp-compliane.orglgmp-news/auropean-ashortys-inspecton-nings-n-the-aree-validaton-quaifcation 1222017 European Authoriy's inspection Findings inthe Arca Validation Qualifcation- ECA Academy Cookies help us in providing our services. By using our services, you agree that we use cookies. Further itplwwn gmp-compliane.orglgmp-news/auropean-ashortys-inspecton-nings-n-the-aree-validaton-quaifcation oK 2