Gmp audit checklist pharmaceutical
[DOC File]SUPPLIER QUALITY EVALUATION QUESTIONNAIRE
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(if applicable) Corrective action reports for identified temperature excursions Vertical audit of laboratory results and corresponding QC data for results of a randomly selected sample Other (please add any additional site-specific pharmacy documents below) Site FDA Inspection Preparation Checklist. v 1.0 22Nov10 Page 4 of 9
[DOCX File]APPLICATION CHECKLIST (ICH CTD)
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Yes No N/A 2.3 Do you maintain records of the training? Yes No N/A 2.4 Is your personnel aware that the products supplied are used for the manufacturing of active pharmaceutical ingredients? Yes No N/A 2.5 Does the Training Program in place have the following elements: 2.5.1 Formal Introduction to Regulatory Guidance (GMP, ISO, etc.)
[DOCX File]APPLICATION CHECKLIST (ICH CTD)
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: GMP certificate/ proof of GMP compliance and the latest inspection report issued by the chosen reference agency should be submitted. If applicable, either the Application for GMP Evidence Evaluation or Application Form for Requesting An Overseas GMP Audit should be submitted for finished product manufacturing sites which are new to Singapore.
GMP Audit Checklist: Free Templates | SafetyCulture
Good Manufacturing Practice – GMP . Audit . Checklist. Sr. # (Contents) ... Are pharmaceutical products designed and developed according to the requirement of GMP & other associated codes such as good laboratory practice (GLP) and good clinical practice (GCP)? ... Do you have an effective internal GMP inspection program to audit all the ...
[DOC File]SITE FDA INSPECTION PREPARATION CHECKLIST
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6.4.9 Is the audit closed after final approval of the audit report from management? 6.5 Performance Evaluation and Improvement - Management Review PROCEDURE MDSAP QMS P0005 – Management ...
[DOCX File]GOOD MANUFACTURING PRACTICE (EMP) CHECK LIST
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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.
[DOCX File]Guide: GMP checklist for ATMP manufacturers
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: a GMP certificate/proof of GMP compliance and the latest inspection report issued by the chosen reference agency should be submitted. If applicable, either the Application for GMP Evidence Evaluation or the Application Form for Requesting An Overseas GMP Audit should be submitted for finished product manufacturing sites which are new to ...
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