Change Management

Selection criteria for an auditor for vendor qualification / audit

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The following factors are used to choose an auditor for vendor qualification: 1. Experience and Qualifications: 2. Technical Proficiency: 3. Auditing Proficiency: 4. Self-reliance and impartiality: 5. References and Reputation: 6. Adherence to Regulatory Mandates: 7. Audit Methodology and Approach: Organizations can choose a skilled auditor to assess vendors and guarantee adherence to industry standards and legal obligations by taking these factors into account.

UNDERSTANDING OF SUPAC GUIDELINES (SCALE UP AND POST APPROVAL CHANGES):

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This guidance provides recommendations to sponsors of new drug applications (NDA’s), abbreviated new drug applications (ANDA’s), and abbreviated antibiotic applications (AADA’s) who intend, during the post approval period, to change: SU: Scale-up during original dossier assessment. Note that this is not SU during development. Consider changes made after the Biobatch   PAC: Post-PQ/post-approval, i.e. Variations. … Read more

BASIC UNDERSTANDING OF QUALIFICATION, CALIBRATION AND PREVENTIVE MAINTENANCE:

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QUALIFICATION: Qualification is the planning, carrying out and recording of tests on equipment and systems, which form part of the validated process, to demonstrate that it will perform as intended. All manufacturing equipment, laboratory instrument and supporting utilities shall be considered for qualification. After successful completion of qualification exercise, the Equipment / instrument / Utilities … Read more

BASIC UNDERSTANDING OF AREA AND ROOM CONDITIONS:

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The premises used for warehousing, manufacturing, processing, storage, packaging labeling and testing purposes shall be; WAREHOUSING AREA: PRODUCTION AREA: ANCILLARY AREAS: QUALITY CONTROL AREA: REFERENCE: 1. Schedule M 2. 21 CFR art 210 & 211 3. WHO Technical Report Series 908