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Understanding GMP Audit Procedures

A GMP audit comprehensively inspects a production company to identify flaws and violations. It communicates quality standards and guidance. There are internal audits to ensure meeting quality standards, external audits by third-party suppliers, product audits to check design specifications, process audits comparing processes to requirements, and system audits reviewing the entire quality system. GMP audits are important to adopt quality standards throughout the supply chain and ensure proper documentation and product quality. The audit process involves planning, investigating by documenting relevant information from records and procedures, and preparing a written report.

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Mark Anthony Centeno
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295 views10 pages

Understanding GMP Audit Procedures

A GMP audit comprehensively inspects a production company to identify flaws and violations. It communicates quality standards and guidance. There are internal audits to ensure meeting quality standards, external audits by third-party suppliers, product audits to check design specifications, process audits comparing processes to requirements, and system audits reviewing the entire quality system. GMP audits are important to adopt quality standards throughout the supply chain and ensure proper documentation and product quality. The audit process involves planning, investigating by documenting relevant information from records and procedures, and preparing a written report.

Uploaded by

Mark Anthony Centeno
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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GMP Audit :

Presented by - Sweety Shukla


Audit: A GMP audit is a comprehensive, third-party inspection of a production company. It means
identifying operational flaws and legal v iolations. Along with specific inspection results, GMP audits are
meant to communicate a set of standards and guidance on how to meet these standards.
Auditing is the systematic examination of a Quality system.

Scope and objective :

• To ensure the quality product.


• To access the effectiveness of the Quality assurance
system
• It permits the timely correction of the problem
• It established a high degree of confidence
• It provides a stimulus for the improvement
• Build interdepartmental trust, Understanding, and
communication
Types of Quality Audits :

Internal Audit

External Audit

Product Audit

Process Audit

System Audit
Internal Audit
➢ Internal audit ensures that an organization is meeting
its own quality standards or contractually required
standards. This is also called a first-party audit.
➢ It may be done by the auditors, who work for the
company being rev iewed, they may also be hired
by the company to audit its own function.
For example - a manufacturing process may be audited
on a daily basis for quality control.
External Audit
 External audits are performed by your own
company staff that works in Quality but is
experienced to performed audits.
 In pharma/biotech Quality, external audits
are your company’s third-party suppliers who
would supply the raw materials, active
ingredients, and components such as leaflets,
labels, bottles, blisters, and cartons that you
use to make your finished medicinal
products.

 For Example - GMP suppliers are important


for the adoption of quality standards
throughout the supply chain. If every link in
the chain adheres to the same standards, the
result is a measurable improvement in
product quality. When conducted correctly,
an audit also will ensure proper document
management.
Product Audits:
 A product quality audit verifies that a physical
product meets design specifications and another
quality measurement.
 It involves checking the calibration and test
equipment used to verify that the product is of more
quality standard.
For example- an auditing firm may examine whether the
manufacturer's production facility produces a particular
product as the code and specification.
Process Audits:
 A process audits look at specific processes,
activities, or functions performed by an
organization.
 The auditor compares the actual process with
the documented requirements of the process.

For example- the auditor might conduct an audit


of the design process, manufacturing process, or
inspection process.
System Audits
 System audits are a review of the quality system used by the
company it is a review of how the quality standard is
measured and met by the company.
For example- the auditor might audit the design process,
manufacturing process, inspection, and other processes together.
In addition, the auditor also looks at the interaction between
these processes. how the design function and manufacturing
interact with each other, how defects are recorded, and how the
company ensures that failed product is not passed.
Why do we need help conducting the GMP audits ?

Our quality professionals bring direct experience in pharma/


biotech combination and medical devices development
and manufacturing to help understand and address quality
assurance need at every stage of product development.
What are involved in the GMP audit process?

The auditor Plans the audit.

The auditor document relevant information during their investigation


into your organization’s system and procedure for ensuring the GMP
compliance

For Example manufacturing records.

The auditor prepares the written Report.

GMP Audit : Presented by - Sweety Shukla
Audit: A GMP audit is a comprehensive, third-party inspection of a production company. It means identifying operational fla
Types of Quality Audits : Internal Audit External Audit Product Audit Process Audit System Audit
Internal Audit  Internal audit ensures that an organization is meeting its own quality standards or contractually required
External Audit  External audits are performed by your own company staff that works in Quality but is experienced to perfo
Product Audits:  A product quality audit verifies that a physical product meets design specifications and another quality
Process Audits:  A process audits look at specific processes, activities, or functions performed by an organization.  T
System Audits  System audits are a review of the quality system used by the company it is a review of how the quality stand
Why do we need help conducting the GMP audits ? Our quality professionals bring direct experience in pharma/ biotech combina
What are involved in the GMP audit process? The auditor Plans the audit. The auditor document relevant information during the

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