Audit Agenda is a key aspect of Audit Management for not only Pharma Industry. It consists of many parameters to gather information for further assessment.
Audit Agenda Template of Pharmaceutical
A model template for Pharmaceutical Industry has been provided here for guidance purposes.
Company Name
Audit Agenda
Number: ###
| Audited Company: | |
| Location of the site: | |
| Country: | India/USA/UK/China |
Audit date:
Auditor (lead):
E-mail:
Co-Auditor(s): /
E-mail: /
Participant(s): /
Audit Programme:
| The first audit of the site | Re-audit |
Subject and purpose of the audit:
The subject of an audit is the following material(s):
The purpose of the audit is to address the compliance of the manufacturer with the provisions of the Reference documents listed below.
Reference documents:
| Eudralex, The rules governing medicinal products in the European Union, Volume 4: Guidelines for good manufacturing practice for medicinal products for human and veterinary use (EU-GMP), Part II – Basic requirements for Active Substances used as Starting Materials. |
Audit Agenda – Introduction meeting
Making an Introduction meeting part of the Audit Agenda is a good practice.
• Presentation of the company
• Basic information about the company, if not included in the presentation: – Site layout, – Number of employees (total, QA, QC), – Organogram and responsibilities of employees (with focus on QA/QC function), – Computer/manual material management system, – Review of local and foreign inspections: o GMP approvals, o ISO 9001/14001 certificates, other certificates. – Contract manufacturing/laboratory testing.
• Nature of other products manufactured by the audited site: – API’s, – Potent drugs, – Hormones, – Penicillin or cephalosporin antibiotics, – Non-medicinal products. (Please prepare a list of APIs by individual production blocks with a focus on the manufacturing equipment used for audited API)
• Review of the manufacturing processes (please prepare reaction schemes or flow charts of the processes).
Audited areas: Quality Management System
| Site Master File and Quality Manual |
| Documentation system, SOP system, list of SOPs |
| Annual Product Quality Review for audited API’s |
| Evaluation and investigation of OOT results, OOS results, and deviations |
| Change control system |
| Vendor approvals |
| Other particularities connected to herbal drugs according to GMP Annex 7 (if applicable) |
| Health, Safety, Environment (HSE) management system |
Personnel
| List of key personnel |
| Requirements for qualifications and experience on different levels |
| Job descriptions, responsibilities |
| Training (schedule records) |
| SOPs about hygiene, clothing, smoking, eating, drinking, personnel suffering from infectious diseases / open lesions. |
Premises and equipment
| Warehouses (raw material, packaging material, and finished products warehouse): Documentation and records, Receipt of incoming materials, Identification and labeling, Sampling, Quarantine, Release, Separation of materials: quarantine/approved/rejected – FIFO/FEFO system, Temperature and humidity monitoring/control, Vermin control, Recalled & returned goods, Access control, Reduced testing program. |
| Manufacturing equipment: Dedicated or non-dedicated equipment, Identification (equipment, pipelines/processing lines), Logbooks, status boards, Calibrations of instruments, Cleaning procedures and records, Schedule/procedures/records for preventive maintenance, Qualification of equipment. |
Documentation
| Batch Manufacturing Records for randomly selected batches for audited API’s. |
| Validation documentation for audited API’s |
| Validation of Analytical Procedures |
| Cleaning validation |
| Specification requirements for starting materials for herbal substances/preparations (if applicable) |
Audit Agenda for Production
| Production operation (preferably we would like to see the production of audited API’s in operation) |
| Issuing of batch records |
| Are the critical steps witnessed by the second person? |
| IPC sampling and control, records, acceptance criteria, raw data |
| Process parameter control |
| Measures to prevent mix-up and contamination/cross contamination |
| Recovery of solvents and reagents, treatment of mother liquors (second crops?) |
| Blending/homogenization of batches |
| Blending of tails |
| Packaging and labeling/records of the finished products |
| Maintenance program – schedule, records |
| In-line records |
| The layout of the clean area and HVAC system |
| Material flow and personnel flow in the clean area |
| Temperature and relative humidity in the clean area (requirement and records) |
| Process water, purified water quality, a pyrogenic water |
| The layout of the purified water system |
| Measurement to prevent microbial growth and accumulation |
| Reprocessing and Reworking |
Quality control Audit Agenda
| Description of sample flow |
| Sampling, procedure, tools |
| Handling of sample received, sample register |
| Testing of raw materials, intermediates and finished products |
| Analytical raw data |
| Log books |
| Preparation and standardization of standards/standards solutions |
| Storing of standards, chemicals and reagent |
| Qualification or validation of the laboratory equipment |
| Retention samples |
| Microbiological tests |
| Endotoxin testing |
| Stability testing of APIs |
| Definition and basis for expiry/retest date |
Outsourced activities
| Contract laboratories |
| Pest control |
Complaints and product recalls
| Customer complaints, returns and recalls, evaluation, responses |
Self-inspection and Tour of the company
| As a part of the audit, tour of the company will also be performed. Tour flow should be organized to include the following points: |
| • Raw material warehouse (solid&liquid) |
| • Packaging material warehouse |
| • Bulk solvents storage |
| • Production (all stages from starting materials on) |
| • Clean area (final API processing, packaging) |
| • Finished product warehouse |
| • Purified water system |
| • Quality control premises |
Closing meeting (Final conclusions)
Please prepare as many documents as possible in advance; additional documentation might also be requested. The schedule might be changed during the audit. Additional topics might be reviewed, depending on findings during the audit.
CONFIDENTIAL
SOP-XXYYZZ
Download Audit Agenda Template (Word format)
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