Gmp certification training
[DOCX File]Guide: GMP checklist for ATMP manufacturers
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Introduction: GMP checklist for ATMP manufactures is based on Part IV- GMP Requirements for Advanced Therapy Medicinal Products of the EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines and contains specific questions about quality work at the GMP facility with references to the corresponding requirements of the regulations and supporting documents.
[DOC File]GMP/GHP MANUAL
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Define the responsibilities and authorities of personnel whose work affecting good manufacturing practices or good hygienic practices and document the separately. Please attach the organizational structure, identifying relevant personnel. ... State how training programmes are conducted please attach the training plan or training schedule if any.
[DOCX File]PE009, the PIC/S guide to GMP for medicinal products
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It is the responsibility of the contract giver to ensure that any laboratories used for ongoing stability testing is appropriate. For that reason, other certification may be used in lieu of a GMP certification, such as a licence issued by a regulatory authority acceptable to the …
[DOCX File]Guidance on the GMP clearance of overseas medicine ...
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Overseas TGA on-site audits involve considerable lead-time in planning to ensure efficient audit visits. The usual lead time for an initial overseas on-site audit or a renewal of a GMP Certification for a site that was previously audited by the TGA is 6 months from the date of an effective GMP Certification …
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