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[DOCX File]Minor Variation Guideline (chemical)
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Signed declaration of manufacture (for each manufacturing site, if relevant) in accordance with the dossier and according to GMP rules (as described in Annex 3a) (or, if the substance is not a drug substance, a suitable quality assurance system
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[DOC File]ADMINISTRATIVE ORDER
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Routine inspection shall be conducted under an announcement when a newly established manufacturing facility or a manufacturer who has expressed interest of expanding manufacturing activities including, premises change or modification, when GMP certification has expired within 5 years.
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[DOCX File]GMP clearance guidance - TGA
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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 TGA or a current ISO 17025 accreditation certificate. Stability test methods used by the laboratory should be appropriately validated and documented, according to the requirements of the PIC/S ...
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[DOCX File]Preamble
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A valid GMP certificate, a CPP which covers the GMP certification or an official document from a relevant authority confirming the new name and/or address (where applicable). An official letter from the product owner authorising the company/manufacturer with …
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[DOC File]Good Manufacturing Practices (GMP’s) Policy
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WHO GOOD MANUFACTURING PRACTICES (GMP): WATER FOR PHARMACEUTICAL USE (WPU) ... Vendor assessment and authorized certification activities, including confirmation of the acceptability of the delivery vehicle, should be undertaken in a similar way as for any other starting material.
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[DOCX File]PE009, the PIC/S guide to GMP for medicinal products
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application for certification of. good manufacturing practices (gmp) certification scheme. doc no. gl-gp-01 date of issue : 2002-01-01 issue no. 01 effective date : 2002-01-01 page : …
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[DOC File]The Director General
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Good Manufacturing Practices (GMP’s) Policy. The purpose of this policy is to ensure compliance with current Good Manufacturing Practice (GMP) regulations for foods. It is the responsibility of all involved personnel at every level of the organization to act immediately if a risk of violating this policy is detected.
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[DOC File]WHO GOOD MANUFACTURING PRACTICES (GMP):
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3. I undertake to ensure that the medicinal products are manufactured in accordance with Administrative Order No. 2012-0008, Adoption and Implementation of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products, or equivalent. 4.
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Good Manufacturing Practices Certificate | GMP Cosmetic Export - …
GMP certification application for a TGA on-site inspection. If your clearance is expired by more than 30 days, you will not be able to vary it via the TGA Business Services portal. Extensions may not be given where an existing clearance has been given a shortened expiry date or has previously not been issued.
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Gmp certification