What are the different types of Audit in a pharmaceutical company?

Overview of Audit Types

The audits can be broadly classified into three main categories:

1. Internal Audits (First-Party)

2. External Audits (Second-Party)

3. Regulatory Audits (Third-Party)

1. Internal Audits (First-Party Audits)

These are audits conducted within the company, by the company, on its own systems, processes, and facilities.

· Purpose: To proactively identify gaps, ensure continuous compliance with internal SOPs and external regulations, and prepare for external audits.

· Conducted By: An independent Quality Assurance unit or internal audit team within the company.

· Key Areas:

· Process Audits: Focusing on a specific manufacturing or control process (e.g., tablet compression, sterilization, water system operation).

· System Audits: Reviewing a quality system in its entirety (e.g., Change Control, Deviations, CAPA, Training, Supplier Management).

· Product-Specific Audits: Auditing all aspects related to a specific product, from development to distribution.

· Facility Audits: Assessing the overall state of a facility, including cleanliness, maintenance, and utilities

2. External Audits (Second-Party Audits)

These audits involve an external organization that has a direct relationship with the company being audited.

A. Supplier/Vendor Audits

This is the most common type of external audit. A pharmaceutical company audits its suppliers to ensure the quality of incoming materials and services.

· Purpose: To qualify and monitor suppliers, ensuring they meet the required quality standards.

· Suppliers Audited:

· Active Pharmaceutical Ingredient (API) Manufacturers

· Excipient Suppliers

· Primary Packaging Material Suppliers (e.g., glass vials, rubber stoppers, blisters)

· Contract Manufacturing Organizations (CMOs) / Contract Testing Laboratories

· Critical Service Providers (e.g., calibration, pest control, logistics)

B. Customer Audits

A customer (e.g., another pharmaceutical company, a large hospital group, or a government procurement body) may audit the manufacturer to gain confidence in the quality of the products they are purchasing.

· Purpose: For the customer to verify the manufacturer's quality systems before entering into a supply agreement.

3. Regulatory Audits (Third-Party Audits)

These are conducted by government regulatory bodies to determine if a company is in compliance with laws and regulations. These are the most high-stakes audits.

Example: FDA Inspections (U.S. Food and Drug Administration)

· Types:

· Pre-Approval Inspection (PAI): Conducted before a new drug is approved to verify the accuracy of data submitted in the NDA/ANDA and to ensure the commercial facility is capable of consistently manufacturing the product.

· Routine GMP Surveillance Inspection: Periodic, unannounced inspections of manufacturing facilities to assess ongoing compliance with GMP regulations.