Why is a Site Audit Important ?

An on-site inspection verifies that your manufacturing, packing, labeling, importation, or distribution facility maintains records of all operations, exercises due care in all circumstances, and complies with all applicable rules. With our experience in offering a specialized, walk-through assessment of your facilities, we will serve as your site audit specialist. For the reasons listed below, conducting a site audit is crucial and should be done on a regular basis.

What Is a Pharmaceutical Quality Audit ?

An independent, systematic audit of pharmaceutical quality will determine whether the operations carried out by your business are following industry standards. Additionally, you'll check to see if they're used efficiently to accomplish the specified goals.
Internal and external quality audits are crucial components of a strong pharmaceutical quality management system. Your pharmaceutical company will be evaluated for regulatory compliance and obtain the necessary feedback for improvement with the help of quality audits.

Types of Audits in the Pharmaceutical Industry in India

Several audits are carried out in the Indian pharmaceutical business to verify compliance with legal requirements, quality control measures, and good manufacturing practices. Here are a few typical audit types in India's pharmaceutical sector:

GMP (Good Manufacturing Practice) Audit

The Central Drugs Standard Control Organization (CDSCO) and other regulatory bodies' policies and requirements are followed by pharmaceutical manufacturing facilities through GMP (Good Manufacturing Practice) audits, which are conducted on these facilities. These audits concentrate on equipment validation, documentation procedures, facility hygiene, and production processes.

GLP (Good Laboratory Practice) Audit

GLP audits are carried out in labs where pharmaceutical goods are the subject of non-clinical safety assessments. The goal is to ensure the integrity and dependability of data produced during preclinical testing by confirming compliance with the GLP standards as specified by the CDSCO.

GDP (Good Distribution Practice) Audit

GDP audits look at how pharmaceutical products are distributed and transported to make sure they're handled, kept, and moved in the right ways to maintain product quality all the way through the supply chain.

Pharmacovigilance Audit

As part of their pharmacovigilance duties, pharmaceutical companies are required to monitor, collect, and report adverse drug reactions (ADRs) to the CDSCO. Pharmacovigilance audits evaluate these systems.

Supplier Audit

Supplier audits are conducted to assess the quality systems and procedures of external suppliers, such as those who provide raw materials, contract manufacturers, and service providers to ensure that they adhere to the appropriate quality standards and maintain the quality of the products or services provided by them.

Internal Quality Audit

A pharmaceutical company's internal quality assurance team conducts internal quality audits to evaluate the efficiency of its quality management system, pinpoint areas for improvement, and guarantee continued compliance with internal policies and industry requirements.

Regulatory Authority Audit

Government health authorities, including CDSCO, perform regulatory authority audits to ensure that regulations are being followed. For pharmaceutical products to be marketed in India, marketing approvals must be obtained and maintained.

Process Validation Audits

Process validation audits examine the manufacturing procedures to ensure that they can reliably produce pharmaceutical goods that adhere to predefined standards of quality.

The entire quality, safety, and regulatory compliance of pharmaceutical goods and procedures are crucially dependent on these audits. To provide safe and effective medications to patients, they assist pharmaceutical businesses in upholding high standards, adhering to best practices, and continuously improving their operations.