This should normally provide sufficient assurance that the results of an audit carried by the third party are credible, thus waiving the need for an audit conducted by the manufacturing-authorisation holder itself. There should be evidence that the contract-giver has evaluated the contract-acceptor with respect to the aspects described above.Īll parties involved should be aware that audit reports and other documentation relating to the audit will be made available for inspection by the competent authorities if requested. If a third party is involved, the arrangements should be subject to chapter 7 of the GMP guideline. These aspects can be inspected as necessary by the competent authorities. conducted by properly qualified and trained staff, in accordance with approved procedures. Section 5.25 of the GMP guideline requires starting materials to be purchased from approved suppliers and about whom the manufacturer has a particular and thorough knowledge.Īn audit conducted by the manufacturing-authorisation holder itself should be integral to the manufacturer's quality-assurance system and subject to the basic GMP requirements, i.e. Small manufacturers may not have the necessary expertise or resource to conduct their own audits. The document 'guidance on the occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers of active substances used as starting materials', published as part of the Community procedures, states that it is expected that manufacturing-authorisation holders will gain assurance that the active substances they use are manufactured in accordance with GMP through audit of the active-substance suppliers. Requirements for active substances used as starting materials in veterinary medicinal products (New Feb 2022).EU GMP guide part IV: GMP requirements for advanced therapy medicinal products (ATMP): Guidelines on GMP specific to ATMPs (New June 2019).Active substance registration (New July 2018).23 (3) of regulation 2021/1248 requirement relating the nature of check at the reception of veterinary medicinal products before being transferred to saleable stock (New Oct. GMP certificates, non-compliance statements and manufacturing authorisations.EU GMP guide annexes: Supplementary requirements: Annex 19: Reference and retention samples (Updated).EU GMP guide annexes: Supplementary requirements: Annex 16 (Updated May 2018).EU GMP guide annexes: Supplementary requirements: Annex 13.EU GMP guide annexes: Supplementary requirements: Annex 11: Computerised systems.EU GMP guide annexes: Supplementary requirements: Annex 8: Sampling of starting and packaging materials: Use of near-infrared (NIR) technology for container-wise identity testing.EU GMP guide annexes: Supplementary requirements: Annex 8: Sampling of starting and packaging materials: Glycerol. ![]() EU GMP guide annexes: Supplementary requirements: Annex 6: Manufacture of medicinal gases. ![]()
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